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WARNING LETTER

Humaworm MARCS-CMS 510114 —

Recipient:
Humaworm

United States

Issuing Office:
New Orleans District Office

United States

 

  

Black HHS-Blue FDA Logo

 

 

 
New Orleans District
404 BNA Drive
Building 200- Suite 500
Nashville, TN 37217
Telephone: (615) 366-7801
FAX: (615) 366-7802

 

February 8, 2017
 
Warning Letter no. 2017-NOL-04
 
UNITED PARCEL SERVICE
Delivery Signature Requested
 
Reba G. Bailey, Owner
Humaworm
609 Lexington Avenue
Carrollton, Mississippi 38917
 
Dear Mrs. Bailey:
 
The United States Food and Drug Administration (FDA) conducted an inspection of your facility, located at 609 Lexington Avenue, Carrollton, Mississippi, on August 16 and 17, 2016. 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 2016 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 201(g)(1)(B) and/or 201(g)(1)(C) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. §§ 321(g)(1)(B) and/or 321(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, 2016; 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 Dysfunction...PMS…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 609 Lexington Ave, Carrollton, Mississippi, between August 16 and August 17, 2016. 
 
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 common---the 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 common---the 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 201(p) of the Act [21 USC 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 USC 331(d), 355(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 502(f)(1) of the Act [21 USC 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 USC 353(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 502(f)(1) of the Act [21 USC 352(f)(1)]. The introduction or delivery for introduction into interstate commerce of these misbranded drugs violate Section 301(a) of the Act [21 USC 331(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, 404 BNA Drive, Building 200 – Suite 500, Nashville, TN 37217. If you have questions concerning the contents of this letter, you may contact Mr. Rivero at (504) 846-6103.
 
Sincerely,
/S/ 
Ruth P. Dixon
District Director
New Orleans District
 
cc: 
Tim Darnell
Director, Field Services
570 East Woodrow Wilson
Jackson, MS 39215-1700

 

 
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