The FDA has taken an aggressive stance on dietary supplement promotion and labeling in recent warning letters involving dietary supplement manufacturers’ and distributors’ response to consumer statements online.In its warning letter to AMARC Enterprises, Inc., the FDA determined that two dietary supplements would be considered new “drugs,” because they were being promoted in ways that showed an intent “for use in the cure, mitigation, treatment, or prevention of disease.” As examples of claims, the FDA cited information on the Customer Experiences page of the website.
These consumer testimonials included:
- A testimonial that a customer of the dietary supplement was free of lung cancer: “…..Thank you again and again for the support that PolyMVA gave my body in my fight against cancer!”
- A testimonial about freedom from ovarian cancer.
- “PolyMVA has done wonders for me. I take it intravenously 2x a week and it has helped me tremendously. It enabled me to keep cancer at bay without the use of chemo and radiation…Thank you AMARC
- One chapter in the book cited use of the dietary supplement by an oncology surgeon with 95 patients, all of whom supposedly improved as a result.
- Another chapter included testimonials for the dietary supplement from a breast cancer patient (“a preoperative ultrasound showed that her tumor had shrunk”), a patient diagnosed with multiple myeloma (“total remission”), and other patients.
With warning letters it can be difficult to pinpoint exactly which claim triggered the FDA action–literally, all of them did, but it is unclear whether one in isolation would have created an enforcement problem. For example, one claim states:
- “In a time when one out of three people can expect to have cancer at some point, it make sense to improve your odds every way you can and Palladium Lipoic Complex…would be an excellent way to do so.”
The mention of cancer is a trigger, although the notion that the dietary supplement is preventative is stated in a roundabout way. Another claim is more obvious:
- “Free-radical accumulation with inadequate antioxidant protection is implied in the causes and effects of many other diseases, including diabetes, Alzheimer’s dementia, heart disease, stroke and arthritis. Palladium Lipoic Complex is a superior antioxidant that could help to prevent these diseases as well.”
There are, in fact, even more obvious claims, such as those claiming that the dietary supplement is effective for certain diseases.
A second dietary supplement involved pet nutrition. One of the less obvious claims here was:
- “Whether your pet is an older pet, is facing a serious illness and/or harsh treatment. . . Poly-MVA for Pets offers nutritional support that can ensure that your animal companion maintains a full, active and enjoyable life.”
- “Many veterinarians across the country are utilizing Poly-MVA for Pets in their protocols for overall pet health and well-being, and when dealing with degenerative disease.”
The message from the FDA is obvious: the FDA will also look to consumer testimonials for evidence that a claim goes beyond the permissible structure/function claims for dietary supplements, and makes disease claims.
- Are not generally recognized as safe and effective for the above referenced conditions and therefore, these products are also “new drugs” under section 201(p) of the Act [21 U.S.C. § 321(p)]. New drugs may not be legally marketed in the U.S. without prior approval from FDA as described in section 505(a) of the Act [21 U.S.C. § 355(a)]. FDA approves a new drug on the basis of scientific data submitted by a drug sponsor to demonstrate that the drug is safe and effective.
- Are offered for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners; therefore, adequate directions for use cannot be written so that a layperson can use this drug safely for its intended uses. Thus, your products are misbranded within the meaning of section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)], in that the labeling fails to bear adequate directions for use. The introduction of misbranded drugs into interstate commerce is a violation of section 301(a) of the Act [21 U.S.C. § 331(a)].
- Further, Poly-MVA for Pets is considered a “new animal drug” under section 201(v) of the Act [21 U.S.C. § 321(v)] because it is not generally recognized, among experts qualified by scientific training and experience to evaluate the safety and effectiveness of animal drugs, as safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling.