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April 20, 2020

Warning Letter

Dear Mrs. Bailey:

The U.S. Food and Drug Administration (FDA) conducted an inspection of your facility located at 109 Barnes Avenue, Carrollton, Mississippi from July 15-19, 2019. 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 2020, 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 201(g)(1)(B) of the Act [21 U.S.C. 321(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 2-3 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 1,000 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 1-2 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 201(p) of the Act [21 U.S.C. 321(p)]. New drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from FDA, as described in sections 301(d) and 505(a) of the Act [21 U.S.C. 331(d), 355(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 502(f)(1) of the Act [21 U.S.C. 352(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 201.5). Prescription drugs, as defined in section 503(b)(1)(A) of the Act [21 U.S.C. 353(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 502(f)(1) of the Act [21 U.S.C. 352(f)(1)]. The introduction or delivery for introduction into interstate commerce of these misbranded drugs violates section 301(a) of the Act [21 U.S.C. 331(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 201(ff)(2)(C) of the Act [21 U.S.C. 321(ff)(2)(C)]. However, we note that your product labeling contains a statement that closely resembles the statement required under section 403(r)(6)(C) of the Act [21 U.S.C. 343(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 402(g)(1) of the Act [21 U.S.C. 342(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 111 (21 CFR Part 111).

1. You failed to establish specifications required by 21 CFR 111.70. 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 111.70(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 111.70(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 111.73 and 21 CFR 111.75. 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 111.75(h)(1), and you must make and keep records of all activities relating to such specifications in accordance with 21 CFR 111.95(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 111.75(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 111.65. 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 111.205(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 111.210.

5. You failed to prepare a batch production record every time you manufacture a batch of a dietary supplement, as required by 21 CFR 111.255(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 111.10(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 111.27(d). For example, on July 15, 2019, 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, 2019.

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 111.365. 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 111.365(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 111.365(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 111.153. 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 111.155(d)(1).

10. 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 111.12(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 111.14(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 403 of the Act [21 U.S.C. 343]. 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 403(q)(5)(F) of the Act (21 U.S.C. 343 (q)(5)(F)) in that the label fails to have supplement facts information as required by 21 CFR 101.36.

2. Your Humaworm for Adults Formula Bulk (aka “Humaworm (Bulk)”) product would be misbranded within the meaning of section 403(s)(2)(B) of the Act [21 U.S.C. § 343 (s)(2)(B)] because the label does not include a statement of identity as a “dietary supplement” as required by 21 CFR 101.3(g).

3. Your Humaworm for Adults Formula Bulk (aka “Humaworm (Bulk)”) product would be misbranded within the meaning of section 403(s)(2)(C) of the Act [21 U.S.C. § 343(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 101.4(h)(1).

4. Your Humaworm for Adults Formula Bulk (aka “Humaworm (Bulk)”) product would be misbranded within the meaning of section 403(e)(2) of the Act [21 U.S.C. § 343(e)(2)] because the label fails to declare the net quantity of contents on the principal display panel as required by 21 CFR 101.7.

5. Your Humaworm for Adults Formula Bulk (aka “Humaworm (Bulk)”) product would be misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343(i)(2)] because the label fails to declare the capsule ingredients as required by 21 CFR 101.4(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 743 of the Act [21 U.S.C. 379j-31] 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. 379j-31(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 ORAHAFEAST5firmresponses@ora.fda.gov. Should you have any questions or comments, please do not hesitate to contact Allison Hunter at (513) 679-2700 X 2134.

Sincerely,
/S/

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