WARNING LETTER
World Health Advanced Technologies Ltd
MARCS-CMS 598247 —
June 11, 2020
Product:
Drugs
Recipient:
World Health Advanced Technologies Ltd
2477 Stickney Point Road, Unit 200A
Sarasota
,
FL
34231
United States
info@enercel.com
Issuing Office:
Center for Drug Evaluation and Research | CDER
United States
WARNING LETTER
June 11, 2020
RE: 598247
Dear World Health Advanced Technologies:
This letter is to advise you that the United States Food and Drug Administration (FDA) has reviewed your website at enercel.com, from which you take orders for your products, “Enercel AM,” “Enercel Forte,” “Enercel Max,” “Enercel Mist-Nasal,” “Enercel Mist Nebulizer,” “Enercel PM,” “Vanicel,” and your injectable products “Enercel Plus” and “Enercel Plus IM.” Based on our review, these products are unapproved new drugs under section 505 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355. Introducing or delivering these products for introduction into interstate commerce violates section 301 of the FD&C Act, 21 U.S.C. 331.
These products are especially concerning from a public health perspective for numerous reasons. Injectable drug products, such as your “Enercel Plus” and “Enercel Plus IM,” can pose risks of serious harm to users; these risks are less likely to occur with topical or ingested products, i.e., those applied to the skin or taken by mouth. Injectable products are delivered directly into the body, sometimes directly into the bloodstream, and therefore, bypass some of the body’s key defenses against toxins and microorganisms that can lead to serious and life-threatening conditions. Your injectable product “Enercel Plus” is further concerning because it is labeled to contain potentially toxic ingredients such as “Lachesis Mutus (venum [sic] of the bushmaster snake),” thereby presenting additional risk of serious harm to patients when delivered directly into the body. Further, your products claim to cure, mitigate, treat, or prevent serious and/or life-threatening conditions such as tuberculosis, hepatitis, and lung cancer, and may cause consumers to forgo, delay, or discontinue medical treatments that have been found safe and effective for such conditions through the FDA review process.
Statements on your firm’s website that establish the intended uses of your products include, but are not limited to, the following:
On the homepage of enercel.com:
• “Enercel® is a complex homeopathic medication that has been used successfully in the treatment of many infections including drug-sensitive and multi-drug resistant tuberculosis; hepatitis B and C; and diarrhea in children.”
• “It has been proven to significantly enhance the activity of Natural Killer [NK] cells. NK cells are an important part of the immune system; they provide first-line defense against many micro-organisms and cancers.”
• “It has shown to be highly effective in a short time – 30 days – for new-onset, presumed Drug-Sensitive Pulmonary TB, and 10 weeks – for confirmed Multi-drug Resistant TB, patients.”
• “It has been proven to improve the Quality of Life of HIV patients and significantly decrease their viral loads.”
• “Lung Cancer Patient Alive Today Because of Enercel®”
On a webpage titled “MOTORCYCLE ACCIDENT BURN VICTIM MIRACLULOUSLY [sic] HEALED” on enercel.com:
• “MOTORYCLE ACCIDENT BURN VICTIM MIRACLUCLOUSLY [sic] HEALED BY TREATMENT ONLY UTILIZING ENERCEL – VANICEL TOPICAL SPRAY”
• “This patient suffered a 3rd degree burn . . . The physician recommended a skin graph . . . The patient chose instead to use only Vanicel spray. The swelling reduced almost overnight.”
On the webpage “Help with Hepatitis C” on enercel.com:
• “A Bio-Chemist/Geneticist re-checked my blood after about a year or of [sic] so using ENERCEL and my Hep. C viral load was under 500,000 from the previous time at 13,000,000. She also stated my cirrhosis was gone and the cancer was cleared.”
The above claims for “Enercel AM,” “Enercel Forte,” “Enercel Max,” “Enercel Mist- Nasal,” “Enercel Mist Nebulizer,” “Enercel PM,” “Vanicel,” “Enercel Plus,” and “Enercel Plus IM” demonstrate that they are drugs, as defined by section 201(g) of the FD&C Act, 21 U.S.C. 321(g), because they are intended to cure, mitigate, treat, or prevent disease and/or intended to affect the structure or function of the body of man or other animals. Moreover, these products are “new drugs,” as defined by 201(p) of the FD&C Act, 21 U.S.C. 321(p), because they are not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in their labeling. Under section 505(a) of the FD&C Act, 21 U.S.C. 355(a), new drugs may not be introduced or delivered for introduction into interstate commerce without prior approval from FDA. No approved application pursuant to section 505 of the FD&C Act, 21 U.S.C. 355, is in effect for these products. Accordingly, the introduction or delivery for introduction into interstate commerce of these products violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a).
We recognize that “Enercel AM,” “Enercel Forte,” “Enercel Max,” “Enercel Mist-Nasal,” “Enercel Mist Nebulizer,” “Enercel PM,” “Vanicel,” “Enercel Plus,” and “Enercel Plus IM” are marketed as homeopathic drugs. Under section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), the term “drug” includes articles recognized in the official Homeopathic Pharmacopeia of the United States (HPUS), or any supplement to it. Homeopathic drug products are subject to the same regulatory requirements as other drugs; nothing in the FD&C Act exempts homeopathic drugs from any of the requirements related to adulteration, misbranding, or approval.
The violations cited in this letter are not intended to be an all-inclusive statement of violations that exist in connection with your marketed 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 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 injunction.
Within fifteen (15) working days of receipt of this letter, please notify this office in writing of the specific steps 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. Your response should be sent by email to FDAADVISORY@fda.hhs.gov.
Sincerely,
/S/
Carolyn E. Becker
Director
Office of Unapproved Drugs and Labeling Compliance
Office of Compliance
Center for Drug Evaluation and Research
Food and Drug Administration
Content current as of:
06/16/2020
Regulated Product(s)
Drugs