Humaworm shut down

Humaworm shut down DEFAULT

Delivery Method:
United Parcel Service
Product:
Drugs
Food & Beverages

Recipient:

Recipient Name

Reba G. Bailey

Humaworm

Lexington Street
P. O. Box
Carrollton, MS
United States

Issuing Office:
Office of Human and Animal Foods Operations East 5

United States


April 20,

Warning Letter

Dear Mrs. Bailey:

The U.S. Food and Drug Administration (FDA) conducted an inspection of your facility located at Barnes Avenue, Carrollton, Mississippi from July , During the inspection we collected your product labeling for your Humaworm for Adults Formula Bulk (aka “Humaworm (Bulk)”) product. Based on our inspection and subsequent review of your product labeling, including product labeling collected during the inspection, and subsequent review of your website at https://www.humaworm.com, we have identified serious violations of the Federal Food, Drug, and Cosmetic Act (the Act) and applicable regulations. You can find the Act and FDA regulations through links on FDA’s home page at www.fda.gov.

Unapproved New Drugs and Misbranded Drugs

FDA reviewed your website at the Internet address https://www.humaworm.com in March , and has determined that you take orders there for the products Humaworm Parasite Cleanse, Humaworm Parasite Cleanse For Children, and Candida & Fungi Cleanse. The claims on your website and on your product labeling for Humaworm for Adults Formula Bulk (aka “Humaworm (Bulk)”) establish that the products are drugs under section (g)(1)(B) of the Act [21 U.S.C. (g)(1)(B)] because they are intended for use in the cure, mitigation, treatment, or prevention of disease. As explained further below, introducing or delivering these products for introduction into interstate commerce for such uses violates the Act.

Examples of some of the claims on your website, https://www.humaworm.com, that provide evidence that your products are intended for use as drugs include:

Home page:
• “We are a family run business that specializes in the creation of herbal formulas for the removal of parasites. . .”

Questions & Answers tab:
• “Do I need to change my diet for HUMAWORM to be more effective?

No – HUMAWORM will work regardless of what you eat. You do need to drink at least 2 quarts of water every day during the cleanse to keep the parasites and toxins flushing out of your body.”

• “When will it take effect?

HUMAWORM will begin working the first day, however you will begin to feel the effects within days. Most parasites are removed during the first 7 days. The rest of the parasites, their larvae and eggs are removed in the next 23 days. Due to the life cycle of a parasite and their ability to migrate throughout the body, it is essential to take the full 30 day dose, even after you’re feeling GREAT!”

• “I have not seen any worms. Is it working?

Yes, if you’re taking HUMAWORM as directed, it’s working. Remember that 70% of parasites are microscopic and not everyone will see visible parasites during the cleanse. Judge the effectiveness by the way you feel overall and take HUMAWORM for the full 30 days, even if you feel GREAT after just a week or two.”

• “I feel like I have the flu! Why????

This is from your body detoxing. HUMAWORM is removing parasites. . .”

Parasite Facts and Figures tab:
• “PARASITE FACTS AND FIGURES

There are four classifications of parasites. 30% live in our digestive systems while the other 70% live all over our bodies including, the blood, and all organs including the brain and even in our eyes and sinus cavities. There are over 1, types of parasites in these four classes that can live in the human body.”

• “BACTERIA, VIRUSES and FUNGUS (mold, yeasts) are ALL in the very broad parasite category.”

• “The following is a partial list from each of the four groups which will give you the general idea about how different parasites wreak havoc on our bodies. . .

NAEGLERIA – this one is found in water and soil, but only one species – naegleria fowleri – can infect humans. The infection mimics bacterial meningitis and affects the brain and spinal cord. . . Infection causes Primary Amebic Meningoencephalitis (PAM), a brain inflammation, which leads to the destruction of brain tissue. . .

MALARIA . . .

CRYPTOSPORIDIUM . . . The infection is called Cryptosporidiosis – also known as crypto. . . They are ideal carriers for many of our autoimmune diseases. During the past 2 decades, crypto has become recognized as one of the most common causes of waterborne disease within humans in the United States. It may be found in drinking water and recreational water in EVERY REGION of the United States AND throughout the WORLD. The most common symptom of cryptosporidiosis is watery diarrhea. Other symptoms include dehydration, weight loss, stomach cramps and/or pain, fever, nausea and vomiting. . .

AMERICAN TRYPANOSOMIASIS – also called Chagas Disease is an infection caused by the parasite Trypanosoma cruzi. . . symptoms include cardiac problems, swollen esophagus and/or swollen large bowel.

TUBERCULOSIS . . .

LYMPHATIC FILARIASIS – . . . people with this parasite will have more bacterial infections. . .

E COLI . . .

LISTERIA. . .

TRICHINELLA. . .

SPIROCHETE – this parasite is carried by lice, ticks, fleas, mites and flying biting insects who all transmit them to humans. They cause relapsing fever, jaundice, Lyme disease, Vincent angina and Wyles disease. . .

PINWORMS . . .

HOOKWORMS. . . In the lungs they can cause pneumonia. In the intestines they hook themselves into the intestinal walls where each one drinks up to 1cc of blood per day causing bleeding and tissue death, not to mention anemia weakness. . . Hookworms also cause asthma, eye pain, insomnia, and dry skin and hair. . . While a light infection may cause no symptoms, heavy infection can cause anemia, abdominal pain, diarrhea, loss of appetite, and weight loss. Heavy, chronic infections can cause stunted growth and mental development. . .

BAYLISASCARIS. . . The symptoms – which can take a week or more to show – include nausea, fatigue, liver enlargement, loss of coordination and loss of muscle control. Severe cases can cause blindness and coma.

SCHISTOSOMIASIS. . . Days after infection, itchy skin or a rash develops – after months, fever, chills, cough and muscle aches set in. . . The eggs can be found in the brain, spinal cord and can cause seizures, spinal cord inflammation and paralysis. The parasite can damage the liver, intestines, lungs and bladder. . .

. . . infection is called CYSTICERCOSIS. When the cysticerci are found in the brain, the condition is called neurocysticercosis. . . Signs and symptoms of infection will depend on how many there are and where in the body they are located. You may feel lumps in the muscles, under the skin. They may float in the eyes causing blurry or disturbed vision. They can also cause swelling of the eyes. In the brain, they cause headaches and seizures – they also cause confusion, lack of attention, balance difficulties and swelling of the brain (hydrocephalus). Heavy infections can cause sudden death.

FISH TAPEWORM. . . It causes anemia, water retention and weight gain as it makes the host uncontrollably hungry.

Alveolar Echinococcosis. . . infection in humans causes parasitic tumors to form in the liver, and, less commonly, the lungs, brain, and other organs. If left untreated, infection with AE can be fatal. . . Symptoms may mimic those of liver cancer and cirrhosis of the liver.”

How We Get Parasites tab:

• “If after reading this section you’re thinking ‘If parasite eggs are everywhere and are so easy to obtain, then why aren’t we ALL infected?’ The answer? 90% of us ALREADY ARE. Here are some examples of how easily you can become a parasite host . . .”

• “HOW & WHY PARASITES MAKE US SICK

Before you read over the following list of symptoms, you need to understand how and why parasites make us sick. Parasites are the HIDDEN DISEASE, they can occur ANYWHERE in the body, in EVERY organ, in ALL tissues, and in the blood. Parasites can cause problems that mimic other disorders and are not diagnosed as being parasite related.”

Symptoms tab:
• “Some Symptoms of Parasite Infections

STOMACH & INTESTINAL COMPLICATIONS – The sheer number of parasites in the lower digestive system and the toxic waste produced by them can cause these problems: Diarrhea[,] Chronic Constipation . . .”

“SKIN DISORDERS & ALLERGIES – Parasites that penetrate the skin cause itching. When tissue becomes inflamed from these parasites, the body’s white blood cells increase to defend the body. . . Symptoms include: . . . Allergies . . . Allergic Reactions to Food. . .”

De-Worming Humans tab:
• “Modern medicine and chemicals used to treat worms are formulated to rid the body of only one type of parasite at a time. Parasites easily migrate to a different part of the body that’s not being treated. Herbal treatments work differently.”

• “HERBAL REMEDIES FOR PARASITE REMOVAL

There are two schools of thought on herbal parasite removal. . . The second school of thought is what HUMAWORM is based on. We have found that a milder dose of parasite killing herbs over a longer period of time is the MOST EFFECTIVE way to rid your entire body of parasites and their toxins. Your body does not go into shock – and all parasites, larvae and eggs are removed over a thirty day period. Most parasites are destroyed within the first week of treatment, however, the remaining larvae and eggs are removed in the next twenty-three days. Parasites will try to migrate to any part of the body that is not being treated so they can stay with you – their host. The HUMAWORM FORMULA treats the entire body so there is NOWHERE for them to hide.”

Order Products tab:
• “Humaworm Parasite Cleanse”

• “Humaworm Parasite Cleanse For Children”

• “Candida & Fungi Cleanse”

CANDIDA & FUNGI CLEANSE tab:
• “CANDIDA & FUNGI CLEANSE”

• “Candida yeast infections are more common today than they have ever been!”

• “When the yeast strain CANDIDA is allowed to overgrow in the body it can cause major problems such as: . . . yeast infections in both men & women. . .athlete’s foot. . .thrush in the mouth and on the genital area. . .”

• “FUNGI overgrowth causes: . . .respiratory problems. . .allergic reaction problems…”

Examples of some of the claims on your Humaworm for Adults Formula Bulk (aka “Humaworm (Bulk)”) product labeling that provide evidence that this product is intended for use as a drug include:

• “This formula is formulated & promoted as a Whole Body Parasite Cleanse.”
• “Taking Humaworm for Adults before eating will ensure that the parasites will get a good belly full of parasite killing herbs instead of thriving off your good nutrition!!!”

Your products Humaworm for Adults Formula Bulk (aka “Humaworm (Bulk)”), Humaworm Parasite Cleanse, Humaworm Parasite Cleanse For Children, and Candida & Fungi Cleanse are not generally recognized as safe and effective for the above referenced uses and, therefore, the products are “new drugs” under section (p) of the Act [21 U.S.C. (p)]. New drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from FDA, as described in sections (d) and (a) of the Act [21 U.S.C. (d), (a)]. FDA approves a new drug on the basis of scientific data and information demonstrating that the drug is safe and effective.

A drug is misbranded under section (f)(1) of the Act [21 U.S.C. (f)(1)] if the drug fails to bear adequate directions for its intended use(s). “Adequate directions for use” means directions under which a layperson can use a drug safely and for the purposes for which it is intended (21 CFR ). Prescription drugs, as defined in section (b)(1)(A) of the Act [21 U.S.C. (b)(1)(A)], can only be used safely at the direction, and under the supervision, of a licensed practitioner.

Your products Humaworm for Adults Formula Bulk (aka “Humaworm (Bulk)”), Humaworm Parasite Cleanse, and Humaworm Parasite Cleanse For Children are intended for treatment of one or more diseases that are not amenable to self-diagnosis or treatment without the supervision of a licensed practitioner. Therefore, it is impossible to write adequate directions for a layperson to use your products safely for their intended purposes. Accordingly, your Humaworm for Adults Formula Bulk (aka “Humaworm (Bulk)”), Humaworm Parasite Cleanse, and Humaworm Parasite Cleanse For Children fail to bear adequate directions for their intended use and, therefore, the products are misbranded under section (f)(1) of the Act [21 U.S.C. (f)(1)]. The introduction or delivery for introduction into interstate commerce of these misbranded drugs violates section (a) of the Act [21 U.S.C. (a)].

Adulterated Dietary Supplements

We note that your product Humaworm for Adults Formula Bulk (aka “Humaworm (Bulk)”) is not labeled as a dietary supplement, and therefore does not meet the definition of a dietary supplement. See section (ff)(2)(C) of the Act [21 U.S.C. (ff)(2)(C)]. However, we note that your product labeling contains a statement that closely resembles the statement required under section (r)(6)(C) of the Act [21 U.S.C. (r)(6)(C)] for dietary supplements that make certain labeling claims. Based on your use of this statement, it appears you may intend to market your product Humaworm for Adults Formula Bulk (aka “Humaworm (Bulk)”) as a dietary supplement. Even if this product was properly labeled as a dietary supplement, and even if this product and your Humaworm Parasite Cleanse, Humaworm Parasite Cleanse For Children, and Candida & Fungi Cleanse products were not unapproved new drugs or misbranded drugs, these products would be adulterated dietary supplements under section (g)(1) of the Act [21 U.S.C. (g)(1)] because the products have been prepared, packed, or held under conditions that do not meet the Current Good Manufacturing Practice (CGMP) regulations for dietary supplements in 21 Code of Federal Regulations Part (21 CFR Part ).

1. You failed to establish specifications required by 21 CFR Specifically:

a. You failed to establish specifications for dietary supplement labels (label specifications) and for packaging that may come in contact with dietary supplements (packaging specifications), as required by 21 CFR (d). Specifically, you did not establish label specifications or packaging specifications for any of your dietary supplements. Packaging that may come into contact with dietary supplements must be safe and suitable for its intended use and must not be reactive or absorptive or otherwise affect the safety or quality of the dietary supplement.

b. You failed to establish product specifications for the identity, purity, strength, and composition of the finished batch of the dietary supplement, and for limits on those types of contamination that may adulterate, or that may lead to adulteration of, the finished batch of the dietary supplement to ensure the quality of the dietary supplement, as required by 21 CFR (e). In particular, you did not establish finished product specifications for any of your dietary supplements.

Once you have established specifications, you must determine whether the specifications are met in accordance with 21 CFR and 21 CFR You must also ensure any tests and examinations you use to determine whether the specifications are met are appropriate, scientifically valid methods, as required by 21 CFR (h)(1), and you must make and keep records of all activities relating to such specifications in accordance with 21 CFR (b).

2. You failed to conduct at least one appropriate test or examination to verify the identity of any component that is a dietary ingredient, prior to its use, as required by 21 CFR (a)(1)(i). Specifically, you did not conduct any test or examination to verify the identity of any dietary ingredient prior to its use in manufacturing your dietary supplements.

3. You failed to implement quality control operations in your manufacturing, packaging, labeling, and holding operations for producing the dietary supplement to ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the master manufacturing record (MMR), as required by 21 CFR For example, during the inspection, our investigators observed that you did not follow your quality control written procedures, titled “Quality Control Requirements for the Production of Humaworm Dietary Supplements.”

4. You failed to prepare and follow a written MMR for each unique formulation of dietary supplement that you manufacture, and for each batch size, to ensure uniformity in the finished batch from batch to batch, as required by 21 CFR (a). For example, it was observed during the inspection that you did not have a written MMR for the Humaworm for Adults Formula Bulk (aka “Humaworm (Bulk)”) product you manufacture. For each unique formulation of a dietary supplement you manufacture, you must prepare and follow an MMR that includes the information specified in 21 CFR

5. You failed to prepare a batch production record every time you manufacture a batch of a dietary supplement, as required by 21 CFR (a). For example, it was observed during the inspection that you did not prepare a batch production record for the Humaworm for Adults Formula Bulk (aka “Humaworm (Bulk)”) product you manufactured.

6. Your personnel failed to use hygienic practices to the extent necessary to protect against contamination of components, dietary supplements or contact surfaces, as required by 21 CFR (b). Specifically, during the inspection, an employee was observed scooping your Humaworm for Adults Formula Bulk (aka “Humaworm (Bulk)”) powder into packaging bags with ungloved soiled hands, while wearing a soiled apron, unsecured personal jewelry, and no hairnet. This employee was observed storing food products for personal use in the processing room and admitted to our investigators that she eats in the processing room.

7. You failed to maintain, clean, and sanitize, as necessary, all equipment, utensils, and any other contact surfaces used to manufacture, package, label or hold components or dietary supplements, as required by 21 CFR (d). For example, on July 15, , our investigators observed product residue on a manual capsule filler and processing table from a batch of another product that you said you manufactured on July 12,

8. You failed to take all necessary precautions during the manufacture of a dietary supplement to prevent contamination of components or dietary supplements, as required by 21 CFR For example, you failed to perform manufacturing operations under conditions and controls that protect against the potential for growth of microorganisms and the potential for contamination, as required by 21 CFR (a). You also failed to perform mechanical manufacturing steps by any effective means to protect the dietary supplements against contamination, by, for example, cleaning and sanitizing contact surfaces, as required by 21 CFR (h).

9. You failed to establish and follow written procedures for fulfilling the requirements that apply to components of dietary supplements, as required by 21 CFR Specifically, during the inspection it was observed that you did not identify each lot of components that you receive in a manner that allows you to trace the lot to the supplier, the date received, the name of the component, the status of the component (e.g., quarantined, approved, or rejected), and to the dietary supplement that you manufactured and distributed, as required by 21 CFR (d)(1).

You failed to ensure that each person engaged in manufacturing, packaging, labeling or holding, or in performing any quality control operations, has the education, training, or experience to perform the person’s assigned functions, as required by 21 CFR (c). Specifically, you failed to ensure that employees are trained on the applicable dietary supplement CGMP requirements, as shown by your employee’s statement that she has not received training on CGMP requirements and by her failure to use hygienic practices to the extent necessary to protect against contamination of components, dietary supplements, and contact surfaces.

Furthermore, you must make and keep documentation of training, including the date of the training, the type of training, and the person(s) trained, as required by 21 CFR (b)(2).

Misbranded Dietary Supplements

Even if your Humaworm for Adults Formula Bulk (aka “Humaworm (Bulk)”) product was not an unapproved new drug and a misbranded drug, and your product was properly labeled as a dietary supplement, your product would also be a misbranded dietary supplement under section of the Act [21 U.S.C. ]. If you intend to market your Humaworm for Adults Formula Bulk (aka “Humaworm (Bulk)”) products as a dietary supplement, our label review shows that this product is not properly labeled as a dietary supplement. If you intend to market your products as dietary supplements, they must comply with the applicable statutory and regulatory requirements for dietary supplements. If this product was a dietary supplement, it would be misbranded for the following reasons:

1. Your Humaworm for Adults Formula Bulk (aka “Humaworm (Bulk)”) would be misbranded within the meaning of section (q)(5)(F) of the Act (21 U.S.C. (q)(5)(F)) in that the label fails to have supplement facts information as required by 21 CFR

2. Your Humaworm for Adults Formula Bulk (aka “Humaworm (Bulk)”) product would be misbranded within the meaning of section (s)(2)(B) of the Act [21 U.S.C. § (s)(2)(B)] because the label does not include a statement of identity as a “dietary supplement” as required by 21 CFR (g).

3. Your Humaworm for Adults Formula Bulk (aka “Humaworm (Bulk)”) product would be misbranded within the meaning of section (s)(2)(C) of the Act [21 U.S.C. § (s)(2)(C)] because the label fails to identify the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient in the product is derived, as required by 21 CFR (h)(1).

4. Your Humaworm for Adults Formula Bulk (aka “Humaworm (Bulk)”) product would be misbranded within the meaning of section (e)(2) of the Act [21 U.S.C. § (e)(2)] because the label fails to declare the net quantity of contents on the principal display panel as required by 21 CFR

5. Your Humaworm for Adults Formula Bulk (aka “Humaworm (Bulk)”) product would be misbranded within the meaning of section (i)(2) of the Act [21 U.S.C. § (i)(2)] because the label fails to declare the capsule ingredients as required by 21 CFR (a) and (g).

The violations cited in this letter are not intended to be an all-inclusive statement of violations that exist at your facility or in connection with your products. You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations.

You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure and injunction.

Within fifteen working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the time within which you will complete the correction. If you believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration.

Section of the Act [21 U.S.C. j] authorizes FDA to assess and collect fees to cover FDA’s costs for certain activities, including re-inspection-related costs. A re-inspection is one or more inspections conducted subsequent to an inspection that identified noncompliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved. Re-inspection related costs means all expenses, including administrative expenses incurred in connection with FDA’s arranging, conducting, and evaluating the results of the re-inspection and assessing and collecting the re-inspection fees [21 U.S.C. j(a)(2)(B)]. For a domestic facility, FDA will assess and collect fees for re-inspection related costs from the responsible party for the domestic facility. The inspection noted in this letter identified noncompliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any re-inspection-related costs.

Please send your reply to Allison C. Hunter, Compliance Officer, Food and Drug Administration, at the above address or email ORAHAFEAST[email protected] Should you have any questions or comments, please do not hesitate to contact Allison Hunter at () X

Sincerely,
/S/

Steven B. Barber
Division Director
Office of Human and Animal Foods Operations East 5

  • Content current as of:

Sours: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/humaworm

On Facebook, fears of parasites push people to post pictures of feces and pursue dangerous remedies

Fears of parasites have led thousands of people to post pictures of their own feces in a private Facebook group and then pursue a range of remedies proposed by other group members that medical experts consider unsubstantiated by scientific research and potentially dangerous.

The posts are another example of the wide variety of health misinformation that can be found on Facebook, and add to the pressure on the social media giant to rein in such misinformation, if not ban it outright.

The posts in these groups follow a clear pattern: A member writes about a perceived health condition or symptoms along with any regimen they’re undergoing. Then, in the first comment, the member usually follows up with a photo of what they claim is their poop.

These people are all convinced that their bodies are littered with parasites.

“What is this? It feels like a slug. It is at least 2 inches long and it is the only thing that came out. Pic in comments,” reads a recent post in the Humaworm Parasite Removal & Natural Health Group, which has 33, Facebook members.

Humaworm is just one of many Facebook groups in which people come together to share and diagnose what they claim are parasitic infections. The groups also share a variety of treatments that are not backed up by science.

One private group with 1, members, called “Parasites cause all Disease,” promotes drinking turpentine to cure ailments.

Parasites, which are organisms that live on or in a host that also serves as its food source, are a legitimate health concern and can cause diseases such as malaria, toxoplasmosis and Chagas disease. But the claims made by Humaworm and other parasite groups — that 90 percent of Americans are hosts to parasites that are making them seriously ill — are drastically overstated, according to data from the Centers for Disease Control and Prevention.

And while these groups have been under pressure from authorities, including a recent raid by federal agents on the business behind the Humaworm group, they have so far been successful in sidestepping Facebook’s broader crackdown on health misinformation in part by adapting to new rules, including the use of coded phrasing such as “fairy tales” in an attempt to portray their activities as works of fiction.

The group’s members, however, clearly take the topic seriously. Many of the posts come from parents looking for ways to treat what they believe are parasites in their children.

“What is a safe way to start a 5 year old on a parasite treatment/cleanse?” one mother posted this week.

Federal action

In the last year, health advocates and lawmakers have been increasingly critical of social media platforms including Facebook and YouTube for hosting and recommending content that spreads health misinformation.

While Facebook has made moves to downrank anti-vaccination pages and provide warnings on pages and groups that push vaccine misinformation, they’ve stopped short of banning accounts that promote such content. This summer, Facebook said it would reduce the reach of posts with “exaggerated or sensational health claims” but have declined to act on groups that promote potentially dangerous cure-alls.

Facebook did not respond to questions concerning the Humaworm community, but groups promoting similar products of questionable safety have been removed for violating Facebook’s rules on “nonmedical drugs,” which forbid content that promotes drug sales or describes personal drug use outside of recovery.

But the specter of a ban hangs over the groups, an indication that Facebook’s crackdown has forced these groups to change how they work.

Federal agents executed a search warrant last month at Humaworm’s headquarters in Carrollton, Mississippi, a business from which Reba Bailey, 48, made and sold homemade herbal pills that she claimed could cleanse the body of parasites and treat nearly every illness — from headaches to cancer. Agents confiscated equipment, herbs, and computers, according to Bailey’s social media posts.

The raid drove Bailey to make the Humaworm group private.

“ANNOUNCEMENT: HUMAWORM IS CLOSED AS OF TODAY,” Bailey posted to her then-public group. “I can't talk about why. I WILL BE HIDING THIS GROUP.”

Following the October raid, Bailey changed the name of her Facebook group from Humaworm Parasite Removal & Natural Health Group to Parasites & Natural Health, and she and her group members have started referring to specific herbal recipes as “fairy tales” to evade what they fear is a forthcoming Facebook ban, according to posts viewed by NBC News.

“Is there a fairy tale goldilocks porridge recipe for Lyme in a five yr old or nursing mom?” one member asked after Bailey released the recipes for several other herbal remedies.

Many of the posts in Bailey’s group are not from people seeking advice for themselves, but from parents looking for ways to treat what they believe are parasites in their children.

“Omg my 5 month old just passed about 50 worms 🐛 how can a baby that young pass so many and have so many!” another posted in the Humaworm group, along with a photo of a dirty diaper.

Many of the comments suggested that solutions offered by Humaworm are meant to “detoxify” the baby, while other replies advised the mother to stop feeding her child bananas.

One responded, “It’s just baby poop.”

Bailey did not answer requests for comment sent through email and FB message, and a message left at the company phone number was not returned. A GoFundMe campaign for Bailey’s living expenses has raised $3,, and she has quickly written a book of recipes for her products that she’s selling for $

The FDA declined to comment on the raid “as a matter of policy,” according to a spokesperson.

‘Seek medical care’

The internet provides a wealth of information and connectivity for the sick and their doctors. But for people who are overly anxious, isolated or hopeless about symptoms that doctors have been unable to name or treat, online diagnoses and involvement in social media groups like those dedicated to parasite cleanses on Facebook can increase their fears, a phenomenon known as Cyberchondria.

The misguided belief that one’s body is being overrun by worms also has a name: delusional parasitosis.

Posts in the parasite Facebook groups document the effects of many of the suggested remedies. Humaworm and other non-FDA-approved “miracle” parasite cures have caused general pain, rashes, headaches, fevers, heart irregularity and flu symptoms, according to posts seeking confirmation that these are symptoms of parasite “die-off.” They claim the negative effects are actually a positive sign, triggered by the dying parasites.

“These types of cures are things we used to see before medical knowledge or research,” said Jennifer Grygiel, an assistant professor and social media researcher at the S.I. Newhouse School of Public Communications at Syracuse University. “The news media environment is degrading so badly that we’re digressing backwards, toward medieval times.”

“People are reading less about medicine from journalists or medical professionals,” Grygiel said. “It’s not even Doctor Google anymore. People are becoming more reliant on social media, and Facebook is reaping the benefits.”

The group’s move to become hidden also poses challenges for those trying to find and address health misinformation online.

“Groups can become private or hidden at any time, making it hard for journalists and researchers to show what is happening on Facebook,” Grygiel said. “And that’s strategic on Facebook’s part.”

Side effects aside, using a photo on Facebook to diagnose a parasitic infection is unreliable, said Dr. Benjamin Levy, the division head of gastroenterology at Mount Sinai Hospital in Chicago.

“Appearance of stool is helpful when trying to determine hydration status,” Levy said. But people concerned about parasites “should go see a doctor and have the physician order stool testing, where a lab can look at the sample under a microscope.”

Levy offered a warning about enemas, supplements and other at-home remedies promoted by group members.

“Depending on the device or the substance used, you can cause irritation or abrasions and you may be sloughing off skin or mucosa and exacerbating hemorrhoids,” Levy said. “In , we have great medications that have been studied and deemed safe. My advice would be to seek medical care before going on the internet for solutions.”

Brandy Zadrozny is a senior reporter for NBC News. She covers misinformation, extremism and the internet.

Sours: https://www.nbcnews.com/tech/tech-news/facebook-fears-parasites-push-people-post-pictures-feces-pursue-dangerous-n
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Parasites in humans more prevalent than we think

Back in the s and &#x;40s American mothers dewormed their horses, cows, cats, dogs and their kids with a not so tasty drink each fall and spring, made with wormwood, diatomaceous earth, castor oil and molasses.

This wisdom passed down from generations of mothers had one goal: to rid their family and animals from parasites, which are organisms that depend on a host for food.

Today that tradition has been replaced with the idea that parasites only affect those who travel abroad and drink the water.

This widely accepted theory is inaccurate as parasitic infections affect millions of people in the United States every year, according to the Centers for Disease Control.

Pam Gerry is a nurse in Sanford, Maine, who works as a colon hydro therapist and considers her science laboratory the stool she urges out of her patients' bodies with up to 10 gallons of warm water in the course of a minute treatment. Seven out of every 10 people who visit her office for their first colonic treatment have macroscopic parasites that she can see rush past in the clear tubing.

Of the thousand or so parasites, only 30 percent can be seen with the naked eye, so theoretically we could be missing 70 percent of the parasites that come in, and already seven out of 10 patients I treat have parasites I can see, she said.

Parasites cause a wide variety of conditions in humans, bloating and daily burping often being the first symptom of a parasite infestation. Other symptoms include skin issues, gluten and lactose sensitivities, insomnia, gastrointestinal upset, irritable bowel syndrome, general bowel changes and a weakened immune system, to name a few.

Some people will crave sugar and this is always a sign of the imbalance in the body. These parasites have the ability to capture our palate and demand we deliver their fuel, Gerry said last week. One of my patients had been on a parasite cleanse for 10 days and she said it was the first time in three years that she had been in the Shaw&#x;s bakery and nothing called out to her. The change is that tangible.

Some of the most common parasites are flat worms, ascaris, rope worms and candida, which is a yeast overgrowth that is technically different, Gerry said, but still a common parasite.

She also warned that when a parasite is present, it is acidic to the human body and its waste is neurotoxic and can cause anxiety, irritability and depression.

How do humans become a host for parasites? There are many, many ways, including eating produce that is not washed and scrubbed with a brush, even if it is organic produce that says triple washed on the packaging.

We have to live defensively. We need to wash the produce before we eat it. It is grown in the dirt and dirt is microbes. There are parasites that live in the dirt, live in the water, live on the mosquitoes, flies, fleas and ticks that bite us, Gerry said. We are commensural with them, we have lived in harmony with the parasites, but they have a job to do, they are scavengers in our bodies, when they overgrow they become problem.

Pet owners are at risk of contracting parasites if they let their pets lick their faces or even change a kitty litter box without a mask on, Gerry said.

Cats have parasites whose eggs go airborne when the box is emptied and can easily be breathed right in.

Gerry said she automatically assumes each person she treats has been exposed to parasites, unless they live in a bubble.

Eating raw fish is a risk, Gerry stressed, as well as medium rare meats, especially pork, which is believed to be the meat with the most parasites.

While most doctors prescribe stool sample testing to determine if someone has parasites, Gerry suggests colonic treatments to cleanse the colon and offer the colon hydro therapist the chance to see the stool in its environment.

Colon hydro therapy offers the ability to read the stool and to observe the conditions that the microbiome create on the stool. It is either going to be opaque and clean and smooth without imperfections with a smooth covering over it or overgrown with slime and full of barnacles, Gerry said. Stool that is imbalanced is like a war zone, looks so different than healthy stool.

There are many available herbal tinctures that cleanse the digestive tract, as well as supplements that when taken semi-annually, can bring balance and health back into the gastrointestinal environment. Gerry recommends Candisol for those with the yeast overgrowth called candida, Humaworm, an herbal anti-parasitical capsule and Paragon, a liquid homeopathic tincture.

When anyone uses an agent against them these parasites have the ability to become resistant right way within a week. They change their own DNA and the subsequent generation becomes resistant to the agent. That is why I recommend Humaworm because it has 26 ingredients and is much harder to resist.

Sours: https://www.seacoastonline.com/news//parasites-in-humans-more-prevalent-than-we-think
Parasite Cleansing for Acne - houseofmanna.org

FDA raids Carrollton business

The U.S. Food and Drug Administration is conducting an investigation into a Carrollton business that sells herbal products and other natural remedies for ailments.

Fifteen armed agents raided Tuesday morning the office of Humaworm, located at Lexington St., across from the Carroll County Courthouse.

The owner of the business, Dr. Reba Bailey, said Wednesday the raid was “very scary,” but that the agents were polite and just following FDA protocol. She said she is confident that the probe, which she expects to take as long as six months, will find no wrongdoing.

Carroll County Sheriff Clint Walker said the agents, from the FDA’s New Orleans office, contacted him when they arrived into town and told him they were going to execute a search warrant of the business. They used space at the sheriff’s office to conduct interviews of Bailey and her two employees.

He said the agents provided him with no further information.

“I’m not sure on the particulars of the case,” Walker said Wednesday.

The sheriff told The Conservative that no arrests were made.

An FDA spokesman declined to provide any details.

“As a matter of policy, the FDA does not comment on possible criminal investigations,” Jeremy Kahn, a press officer, said in an email from his office outside of Washington.

Bailey, however, posted on Facebook Wednesday that the FDA agents confiscated “encapsulating machines, the herbs, the capsules, my computers and all of my old records,” effectively shutting down the business while the federal agency tests all of the herbs and blended formulas to verify their composition.

She wrote that the agents “were looking for illegal drugs — which I have never made — and for any herbs from overseas — which I do not use.”

She wrote that Humaworm, which she started in , has always been in compliance with FDA regulations and passed its regular inspections.

In February , however, the FDA sent Bailey a warning letter, saying it had “found serious violations of the Federal Food, Drug and Cosmetic Act and applicable regulations.” The warning letter was issued following an FDA inspection in August of Humaworm’s office and the federal agency’s subsequent review of the labeling on the products the company sold there and online at www.humaworm.com.

It accused Humaworm of selling unapproved new drugs across state lines and that the products failed to bear adequate directions for their intended use.

That case appears to remain open, although Bailey said in an interview with the Commonwealth later Wednesday that she thought it had been closed. “When they came and inspected this summer, the inspectors did not say that I had anything open with them or any current issues with them.”

The website www.humaworm.com is still active, but it presently has nothing on it other than a landing page. Previously, according to the FDA, it contained numerous assertions that the herbal medicines Bailey creates, such as Humaworm Parasite Cleanser, can be used to deworm their users from parasitic infestations.

A doctor of naturopathic medicine, Bailey maintains that such parasites are the source of many medical problems. Naturopathic doctors believe in the ability of the body to heal itself and use herbal remedies or other alternative therapies — such as acupuncture or massage — to facilitate this healing. They are not licensed to write prescriptions.

Other products sold on the website included those that claimed to be effective against a wide range of diseases, from herpes to Lyme disease.

Bailey said she complied with the objections cited in the warning letter. She changed the name of some of her products and reworded some of the claims of what the products would do for those who used them.

She said the FDA agents who participated in Tuesday’s daylong raid focused mainly on whether she was importing herbs from overseas. She said that she purchases all of her ingredients from a California-based company, and that all of those ingredients come with a certificate of analysis stating the herb’s purity.

“I’m not going to buy something out of the back of a pickup truck, and I’m not going to import undocumented herbs out of China,” she said.

When asked what prompted the raid, Bailey said, “I feel like somebody may have said there was some illegal drug activity going on.”

She said, however, that she did not want to connect that false allegation against Humaworm to her belief that another business venture was undermined by some people in the tiny historic community.

“I don’t want people to think that I feel like I’m a target,” she said. “I don’t want people to think that. You just live and let live and just do the best you can.”

Bailey and her husband, Steve, moved from Oxford to Carrollton with their youngest child seven years ago. At various times, they operated a snowcone stand, an ice cream shop, a mechanic’s shop and, most recently, a grocery store — all of which have since closed.

When the grocery, located in the former 4K convenience store in North Carrollton, closed in July, Bailey was frustrated and said at the time that she and her family would be moving to Orange Beach, Alabama, within a year. They have since revised their plans. Bailey said Wednesday that her son, now a ninth-grader, wants to graduate with his friends and the family will remain at least until then.

She said Tuesday’s raid, while it provided grist for the rumor mill and will be a financial setback, is not a tragedy.

“I had an infant daughter that died in , and she died in my arms. My father died in my arms. Our home burned to the ground in , and we lost everything we owned. Those were tragedies. This is not a tragedy. This is a big bump in the road that we’re going to get over. I believe that. I have to believe that.”

• Contact Tim Kalich at or [email protected]

Sours: https://www.gwcommonwealth.com/news-top-stories/fda-raids-carrollton-business

Shut down humaworm


Recipient:
Humaworm

United States

Issuing Office:
New Orleans District Office

United States


Black HHS-Blue FDA Logo

New Orleans District

BNA Drive
Building Suite
Nashville, TN
Telephone: ()
FAX: ()

February 8,

Warning Letter no. NOL

UNITED PARCEL SERVICE

Delivery Signature Requested

Reba G. Bailey, Owner

Humaworm

Lexington Avenue

Carrollton, Mississippi

Dear Mrs. Bailey:

The United States Food and Drug Administration (FDA) conducted an inspection of your facility, located at Lexington Avenue, Carrollton, Mississippi, on August 16 and 17,  Based on our inspection and subsequent review of your product labeling, we found serious violations of the Federal Food, Drug and Cosmetic Act (the Act) and applicable regulations. We also reviewed your website at the Internet address www.humaworm.com in December and determined that you take orders there for the products “Humaworm Formula”, “Fast Help Formula”, “Liver & Gallbladder Cleanse & Restore”, “Lung Cleanser”, “Natural Anti-Biotic”, “Natural Anti-Viral”, “Herpes Cleansing Formula”, “Lyme’s & Syphillis Cleansing Formula”, “Natural Pain Killer”, “Hu-Mana-Tea!”, “Candida Yeast & Fungi Cleanse,” “Colon Cleanse,” “Lung Cleanse”, and “RG’s Medicated Skin Cream”. The claims on your website and on your product labels establish that the products are drugs under Section (g)(1)(B) and/or (g)(1)(C) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. §§ (g)(1)(B) and/or (g)(1)(C)] because they are intended for use in the cure, mitigation, treatment, or prevention of disease and/or are intended to affect the structure or function of the body. As explained further below, introducing or delivering these products for introduction into interstate commerce for such uses violates the Act. You can find the Act and FDA regulations through links on FDA’s Internet home page at www.fda.gov. 

FDA received your response, dated September 2, ; however, the response is inadequate because it failed to address the following significant violations:

Unapproved New Drugs

FDA reviewed your website at the Internet address examples of some of the website claims which provide evidence your product are intended for use as a drug include:

www.humaworm.com

Home page:

  • FACT: OVER 90% OF AMERICANS HAVE PARASITES”
  • “The Best Parasite Cleanse In The WORLD!”
  • “We are striving to inform the general population of the widespread epidemic of parasite problems right here in America.”
  • “We will teach you about herbs that are used to safely eradicate all parasites from our human bodies.”

How We Get Parasites tab:

  • “‘If parasite eggs are everywhere and are so easy to obtain, then why aren’t we ALL infected?’ The answer? 90% of us ALREADY ARE.”
  • “Deworm YOURSELF and your family twice per year to stay clear of any parasitic infestations!”

Humaworm Formula and Dosing tab:

  • “There are three categories of herbs in our formulas. The first is the herbs that have the ability to kill parasites, their larvae and their eggs. ***The second category of herbs is purifiers. They have the ability to sweep through the body and remove all toxins left over from the parasites. Some clean the blood, while other [sic] clean specific organs…”

Additional Cleansing Formulas tab:

  • “*NEW* FAST HELP FORMULA***This formula is to be used for any type of bacterial/viral infection or any unspecific felling [sic] of ‘unwellness’. Uses include: stomach virus/flu/bug, flu/colds, sinus infections, ear infections, any infection that comes on fast and needs fast relief”
  • “It helps to relieve problems with cirrhosis, fatty liver, jaundice, hepatitis, virul [sic] hepatitis and alcohol poisoning.”
  • “[P]eople who have had pneumonia, bronchitis, emphysema and asthma will find this cleanse MOST beneficial in helping the lungs get clean and strong.”
  • “NATURAL ANTI-BIOTIC This formula will help to more naturally kill bacteria in the body***Elecampane-kills the mycobacteria ‘tubercle bacillus’ which is the lung bacteria that causes tuberculosis.”
  • “NATURAL ANTI-VIRAL This formula helps to naturally kill a wide variety of viruses.***Hyssop kills a very wide variety of viruses including the herpes simplex virus”
  • “HERPES CLEANSING FORMULA This formula will help kill the herpes virus.”
  • “LYME’S & SYPHILLIS [sic] CLEANSING FORMULA***Our Lyme’s & Syphillis [sic] Formula can be taken for 2 weeks on and 4 weeks off as needed for infection.”
  • “NATURAL PAINKILLER Great for nerve pain relief, headaches including migraines and cluster headaches, muscle aches, arthritis and joint pain. Combats chronic pain too.”

Hu-Mana-Tea-Detox Tea tab:

  • “Hu-Mana-Tea- THE Detox Tea!***Hu-Mana-Tea***has been used for decades as a supposed cancer treatment and preventative. “

Herb History and Diagnosis, Deworming Humans tab:

  • “We have found that a milder dose of parasite killing herbs over a longer period of time is the MOST EFFECTIVE way to rid your entire body of parasites and their toxins….”
  • “Most parasites are destroyed within the first week of treatment, however, the remaining larvae and eggs are removed in the next twenty-three days…”

Further Research Links tab:

  • “REAL parasites from REAL people using HUMAWORM products…”
  • “My Journey With Candida…”

Candida and Fungi Cleanse tab:

  • “Candida yeast infections are more common today than they have ever been!  This is from the overuse of anti-biotics….When the yeast strain CANDIDA is allowed to overgrow in the body it can cause major problems such as:…yeast infections in both men & women…jock itch…athlete's foot…skin problems including rashes that won't go away…thrush in the mouth and on the genital area…FUNGI overgrowth causes:…respitory problems…allergic reaction problems…”

How to Know Which Formula to Use tab:

  • “HUMAWORM Parasite Cleanse - is the broad spectrum, whole body parasite cleanse.  This formula will kill parasites, larvae and eggs from ALL OVER the body including organs and the blood….”
  • “Natural Anti-Biotic - we move on from whole body cleansing and will start to deep clean certain things from the body.  Bacterial infections are also considered parasitic and they have their own cell.  This formula is broad spectrum and will kill all types of bacteria.  IF any bacterial infection has plagued you for a long time, for example bladder infections, then I would recommend that the Natural Anti-Biotic be taken after the Humaworm.
  • “Natural Anti-Viral - viruses are teeny tiny.  They do not even have their own cell so they invade other cells and are also considered parasitic.  This is WHY anti-biotics won't kill viruses.  The anti-viral formula WILL kill viruses and it is broad spectrum.  If a viral infection such as shingles is the problem, then the Natural Anti-Viral would be the next thing to take after the Humaworm…”
  • “Lyme/Syphilis Cleanse, Herpes Cleanse - these are designed to go even further than the Anti-Biotic and Anti-Viral and to specifically target these particular pathogens.  Lyme and syphilis are "first cousin" bacteria of the borrelia burgdorferi species and the formula will work for both.  These formulas are to be taken after the Humaworm and the anti-biotic and/or the anti-viral. For example, for Lyme Disease, you would take Huaworm and Hu-Mana-Tea for 30 days, then the Natural Anti-Biotic for 15 days then the Lyme Cleanse for 15 days along with the tea.  This would be a total of 60 days of straight cleansing and you would clean the WHOLE body first, then ANY bacteria that might have taken hold, then you would blast out any reaming borrelia burgdorferi with the Lyme Cleanse….”
  • “Candida Cleanse…This yeast is called candida. It is supposed to be there to aid in digestion and it is great when it is kept under control by the good bacteria. HOWEVER, when a body gets sick from ANY infection and especially any bacterial infection, this upsets the gut balance. Anti-biotics (especially prescription anti-biotics) will KILL ALL BACTERIA in the gut. All of it including the GOOD bacteria. Antibiotcs DO NOT kill yeast!!!! If the good bacteria is not replenished in a timely manner, then the yeast will grow out of control and will stray to other areas of the body. ( Good bacteria can be replenished quickly by simply eating yogurt for a few days. That's it, the body will do the rest.) Candida yeast out of control is the cause of vaginal yeast infections, athlete's foot and jock itch. It is ALL the SAME STRAIN of yeast. In order to get the body cleared of this crazy yeast, you must KILL ALL OF THE YEAST in the ENTIRE BODY! You can't starve it out or wish it away. It must be wiped out all at one time. This is where the Candida Cleanse comes into play. It will kill all of it from all over the body at one time. Then your body will simply get the proper amount of yeast you need from the foods you eat and it will be able to keep a good balance which will allow you to have proper digestion and NOT have fungal infections that are out of control…”
  • “Pain Formula - is OUTSTANDING for any type of nerve pain…”

Symptoms of Parasites tab:

  • “The Symptoms of Parasite Infections… Abdominal Pain… Chronic Fatigue Syndrome… Weeping Eczema…Cutaneous Ulcers…Papular Lesions…Swelling…Sores… Depression… Insomnia… Muscle Pain…Joint Pain…Muscle Cramping…Numbness of the Hands and/or Feet…Heart Pain…Pain in The Navel…Pain in the Back, Thighs or Shoulders…Arthritic Pains…Fast Heartbeat… Hypoglycemia…Anemia… Male Impotence…Erectile DysfunctionPMS…Candida – Yeast Infections…Urinary Tract Infections…Cysts & Fibroids…Prostate Problems…Fever…Peritonitis…Chronic Viral or Bacterial Symptoms…”

Types of Parasites tab:

  • “This is not ALL of them, but this will give you a pretty good idea of what HUMAWORM helps to remove: Ringworm, tapeworms, pinworms, candida albicans (yeast infections) and plasmodia (which is the malaria causing parasite), roundworms including ascaris , hookworms, whipworms, flukes including the blood fluke the anisakid worm and microscopic parasites and all parasitic larvae and eggs.  All microscopic protoza (including blastocystis hominis ) , tuberculosis (Mycobacterium tuberculosis), cholera, scabies, viruses, bacteria and fungi including, pseudomonas aeruginosa, all species of shigella, staph (staph aureus) and strep (Streptococcus), bacteria, fungal infections (ie: yeast infections), threadworms and skin parasites (including scabies).  Cryptococcus neoformans, Aspergillus, Saprolegnia, and Zygorhynchus species. Salmonella typhimurium, and other bacterial species (including sixty + types of fungi and twenty + types of bacteria, including some of the most potent viruses known to man), B. subtilis, P. mirabilis, Salmonella typhi, methicillin-resistant Staph aureus, Staph faecalis, salmonella enteritidis, and V. cholerae , Escherichia, Proteus, Providencia, Citrobacter, Klebsiella, Hafnia, Aeromonas, Vibrio and Bacillus genera, Microsporum, Epidermophyton, Trichophyton, Rhodotorula, Torulopsis, Trichosporon, Cryptococcus neoformans, Entamoeba histolytica and Paramecium caudatum, the herpes simplex virus, and viral infections. Also cystitis, prostatitis, gonorrhea, and syphilis, cholera, giardia, salmonella, and Eschorichia Coli….”

RG’s Medicated Skin Cream tab:

  • “This All-in-One cream is used for :…itching…rashes…poison oak, ivy & sumac…ringworm…skin candida…eczema…psoriasis athlete’s foot…Morgellons…bug bites…acne on face & body…burns…sore muscles…cracked skin…scabies…strongyloides…nail fungus…head lice…jock itch…female vaginal itch…cracked heels and elbows…diaper rashes…pubic lice…dandruff…boils…”

Your website also contains evidence of intended use in the form of personal testimonials recommending or describing the use of products for the cure, mitigation, treatment, or prevention of disease. Examples of some of the testimonials provide evidence your products are intended for use as drugs include:

Testimonials tab:

  • “THRUSH GONE!LUPUS!BREAST CYSTS GONE!ECZEMA GONE!HUMAWORM HELPS WITH GIARDIA! FIBROMYALGIA…MOUTH SORES & ECZEMA ALL CLEARING UP…NATURAL ANTIBIOTIC…HELPED VERTIGO PROBLEM IN OLDER LADY…REMOVED OVER 7 POUNDS OF LIVER FLUKES!NO PAIN!HUMAWORM and WARTS…TAPEWORM IS GONE!HUMAWORM HELPS FIBROMYALGIA SUFFERERS!!MIGRAINE HEADACHES GONE!CHRONIC FATIGUE GONE!ANOTHER CASE OF "CHRONIC FATIGUE" GONE!IBS (IRRITABLE BOWEL SYNDROME) CLEARED!HELPED LOWER BACK PAIN…SCIATICA…CANDIDA…FIBROMYALGIA & CHRONIC FATIGUE…AOTHER FIBROMYALGIA, CHRONIC FATIGUE & THYROID SUFFERER…PROTITIS…”

In addition, FDA reviewed your product labels for “Herpes Formula Capsules”, “Lyme & Syphillis Cleanse Capsules”, “Natural Anti-Viral Capsules”, “Natural Anti-Biotic Capsules”, “Herpes Formula Bulk”, “Lyme & Syphillis Cleanse Bulk”, “Anti-Biotic Formula Bulk”, “Colon Cleanse Capsules”, “Candida Yeast & Fungi Cleanse Capsules and Bulk”, “Pain Reliever Capsules and Bulk”, “Hu-Mana-Tea Bulk”, “45 Day Organ Cleanse Package Capsules and Bulk” which includes the “Lung Cleanse” product,  “Whole Body Cleanse”, “Fast-Help Formula Capsules”, “Anti-Viral Formula Bulk”, and “RG’s Medicated Cream”, following an inspection of your facility at Lexington Ave, Carrollton, Mississippi, between August 16 and August 17,  

Examples of some of the claims on your product labels which provide evidence your products are intended for use as drugs include:

Herpes Formula Capsules:

  • “This formula will help kill the herpes virus.”

Lyme & Syphillis Cleanse Capsules:

  • “Lyme’s Disease and Syphillis have one thing in commonthe bacteria that causes each are “cousin” bacteria, from the Borrelia species of bacteria, therefore, they are both treated naturally in the same way.”

Natural Anti-Viral Capsules:

  • “This formula helps to kill a wide variety of viruses.”

Natural Anti-Biotic Capsules:

  • “This formula will help to more naturally kill bacteria in the body.”

Herpes Formula Bulk:

  • “This formula will help kill the herpes virus.”

Lyme & Syphillis Cleanse Bulk:

  • “Lyme’s Disease and Syphillis have one thing in commonthe bacteria that causes each are “cousin” bacteria, from the Borrelia species of bacteria, therefore, they are both treated naturally in the same way.”

Anti-Biotic Formula Bulk:

  • “This formula will help to more naturally kill bacteria in the body.”

Colon Cleanse Capsules:

  • “It creates a literal “scrubbing sponge”, that will trap and remove parasites, toxins”
  • “[H]elping the body rid itself of toxins”

Candida Yeast & Fungi Cleanse Capsules and Bulk:

  • “The absolute best way to get rid of yeast is to just kill ALL of it from ALL OVER the body. The body will quickly rebalance itself from the foods you eat. This is why there are NO SPECIAL DIET changes necessary while on the CANDIDA YEAST & FUNGI CLEANSE. The Candid Yeast & Fungi Cleanse will also help remove fungi overgrowths that cause toenail and fingernail fungus problems.”

Pain Reliever Capsules and Bulk:

  • “Great for nerve pain relief, including neuropathy, post neuropathy, as well as headaches, (including) migraines & cluster headaches), muscle aches, arthritis, joint pains, lower back pain and chronic pain.”

Hu-Mana-Tea Bulk:

  • “Hu-Mana-Tea is a four ingredient blend based on an old, old formula that has been used for decades as a supposed cancer treatment and preventative…”

45 Day Organ Cleanse Package Capsules and Bulk:

Lung Cleanse

  • “Ex-smokers, people who have had pneumonia, bronchitis, emphysema, and asthma will find this cleanse MOST beneficial in helping the lungs get clean and strong…”

Whole Body Cleanse:

  • “The bacteria fighters are next, which is a broad spectrum cleanse. Once the bacteria is gone, the viruses are the next in line to be removed, again, a broad spectrum viral cleanse. Once these are done, the Candida needs to be removed.”

Fast-Help Formula Capsules:

  • “This formula was formulated with general illnesses in mind, such as the Flu, Common Colds, Stomach Virus, & Sinus Infections.”

Anti-Viral Formula Bulk:

  • “This formula will help to kill viruses in the body.”

RG’s Medicated Cream:

  • “This All-in-One cream has several uses listed below: Itching, Rashes, Poison Oak/Ivy & Sumac, Ringworm, Kin Candida[sic], Eczema, Psoriasis, Athlete’s Foot, Morgellons, Bug Bites, Acne on Face & Body, Sore Muscles, Cracked Skin,Scabies, Strongyloides, Nail Fungus, Head Lice, Jock Itch, Female Vaginal Itch, Cracked Heels & Elbows, Diaper Rash, Pubic Lice, Dandruff, Boils…” 

Your products are not generally recognized as safe and effective for the above referenced uses and, therefore, the products are “new drugs” under Section (p) of the Act [21 USC (p)]. New drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from FDA, as described in Sections (d) and (a) of the Act [21 USC (d), (a)]. FDA approves a new drug based on scientific data and information demonstrating the drug is safe and effective. 

A drug is misbranded under Section (f)(1) of the Act [21 USC (f)(1)] if the drug fails to bear adequate directions for its intended use(s). “Adequate directions for use” means directions under which a layperson can use a drug safely and for the purposes for which it is intended ( 21, CFR ). Prescription drugs, as defined in Section (b)(1)(A) of the Act [21 USC (b)(1)(A)], can only be used safely at the direction, and under the supervision, of a licensed practitioner.

Your products “Humaworm Formula”, “Fast Help Formula”, “Liver & Gallbladder Cleanse & Restore”, “Lung Cleanser”, “Natural Anti-Biotic”, “Natural Anti-Viral”, “Herpes Cleansing Formula”, “Lyme’s & Syphillis Cleansing Formula”, “Hu-Mana-Tea!”, “Candida Yeast & Fungi Cleanse”, “Lung Cleanse”, “Herpes Formula Capsules”, “Lyme & Syphillis Cleanse Capsules”, “Herpes Formula Bulk”, “Lyme & Syphillis Cleanse Bulk”, “Hu-Mana-Tea Bulk”, “45 Day Organ Cleanse Package Capsules and Bulk” which includes the “Lung Cleanse” product, “Fast-Help Formula Capsules”, and “RG’s Medicated Cream” are intended for treatment of one or more diseases which are not amenable to self-diagnosis or treatment without the supervision of a licensed practitioner. Therefore, it is impossible to write adequate directions for a layperson to use your products safely for its intended purposes. Accordingly, “Humaworm Formula”, “Fast Help Formula”, “Liver & Gallbladder Cleanse & Restore”, “Lung Cleanser”, “Natural Anti-Biotic”, “Natural Anti-Viral”, “Herpes Cleansing Formula”, “Lyme’s & Syphillis Cleansing Formula”, “Hu-Mana-Tea!”, “Candida Yeast & Fungi Cleanse”, “Lung Cleanse”, “Herpes Formula Capsules”, “Lyme & Syphillis Cleanse Capsules”, “Herpes Formula Bulk”, “Lyme & Syphillis Cleanse Bulk”, “Hu-Mana-Tea Bulk”, “45 Day Organ Cleanse Package Capsules and Bulk” which includes the “Lung Cleanse” product, “Fast-Help Formula Capsules”and “RG’s Medicated Cream” fail to bear adequate directions for its intended use and, therefore, the products are misbranded under Section (f)(1) of the Act [21 USC (f)(1)]. The introduction or delivery for introduction into interstate commerce of these misbranded drugs violate Section (a) of the Act [21 USC (a)].

The violations cited in this letter are not intended to be an all-inclusive statement of violations, that exist in connection with your products. You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure your firm complies with all requirements of federal law and FDA regulations.

You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in legal action without further notice including, without limitation, seizure and/or injunction. 

Please respond to this office in writing within 15 working days from the date you receive this letter.  Your response should outline the specific steps you have taken to correct the noted violations, including an explanation of how you plan to prevent these violations, or similar violations, from occurring again. You should include in your response documentation and any other useful information that would assist us in evaluating your corrections. If your planned corrections will occur over time, please include a timeframe for implementation of those corrections. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time in which the corrections will be completed.

Please send your reply to Mark W. Rivero, Compliance Officer, U.S. Food and Drug Administration, BNA Drive, Building – Suite , Nashville, TN  If you have questions concerning the contents of this letter, you may contact Mr. Rivero at ()

Sincerely,

/S/ 

Ruth P. Dixon

District Director

New Orleans District

cc: 

Tim Darnell

Director, Field Services

East Woodrow Wilson
Jackson, MS

  • Content current as of:

Sours: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/humaworm
Meet the Worm Dr. Oz Calls the Mother of All Parasites - The Oprah Winfrey Show - OWN

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