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

VIA UPS NEXT DAY AIR

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:
How We Get Parasites tab:
Humaworm Formula and Dosing tab:
Additional Cleansing Formulas tab:
Hu-Mana-Tea-Detox Tea tab:
Herb History and Diagnosis, Deworming Humans tab:
Further Research Links tab:
Candida and Fungi Cleanse tab:
How to Know Which Formula to Use tab:
Symptoms of Parasites tab:
Types of Parasites tab:
RG’s Medicated Skin Cream tab:
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:
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:
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:
Lung Cleanse
Whole Body Cleanse:
Fast-Help Formula Capsules:
Anti-Viral Formula Bulk:
RG’s Medicated Cream:
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

 

This page was posted on July 17, 2017.

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