In what is probably no surprise to most people, dietary supplements probably neither help nor cure diseases like Alzheimer’s, symptoms of attention-deficit disorder (ADD), and attention-deficit/hyperactivity disorder (ADHD). The U.S. Federal Trade Commission (FTC) and the Food and Drug Administration (FDA) sent warning letters to three companies based in Florida, South Carolina, and New Mexico related to claims made in the companies’ advertising that may violate the FTC Act by making false or unsubstantiated claims.
In a letter to Miami, Florida, company Gold Crown Natural Products the FDA questions the company’s claim posted on its website that its “Melatonin Supplements [and] Melatonin Valerian” that “[m]elatonin supplements are used to help Alzheimer’s disease.” The company further claims that “[m]elatonin supplements such [as] melatonin with valerian is also used to treat sunburns, dementia, seasonal affective disorders, epilepsy etc.” In addition to the melatonin products, Gold Crown was also warned on claims for three other supplement products.
The FDA minces no words about these and other claims:
Your products are not generally recognized as safe and effective for the above referenced uses and, therefore, these products are “new drugs” [under the FDA Act]. New drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from FDA …. FDA approves a new drug on the basis of scientific data and information demonstrating that the drug is safe and effective.
The FTC weighs in as well:
[I]t is unlawful under the FTC Act … to advertise that a product can prevent, treat, or cure human disease unless you possess competent and reliable scientific evidence, including, when appropriate, well-controlled human clinical studies, substantiating that the claims are true at the time they are made.
South Carolina’s TEK Naturals likewise offer treatment for such ailments as “some forms of cancer, Parkinson’s disease, and kidney stones,” plus a laundry list of other diseases, none of which the FDA has evidence to support and, as with Gold Crown, TEK Naturals’ products are classified as “new drugs” that may not be introduced without FDA approval. In all, the agencies identified five TEK products.
Pure Nootropics is a New Mexico firm that advertises on its website products to help reduce symptoms of “cognitive decline … (prescribed in Europe to Alzheimer’s patients).” One of the company’s products, “Turkey Tail Mushroom Powder,” helps fight infections, illnesses, and diseases” and is “antibacterial” according to the website. The FDA warns about the company’s claims on seven products.
All three have been given 15 days to respond to the FTC regarding actions the companies have taken to remedy the issues.