Herpes Claim Emerges As Latest FDA/FTC Joint Enforcement Target
This article was originally published in The Tan Sheet
Executive Summary
Strictly Health Corp. makes claims on its websites and in social media postings for its dietary supplements including, “incredible remedy is an advanced and multifaceted herpes treatment that overwhelms and keeps the virus sealed and subdued.”
Herpes treatment is the latest consumer health care product claim to prompt a joint warning from FDA and the Federal Trade Commission, which points out the targeted firm’s URLs also comprise an unsubstantiated claim.
Strictly Health Corp., identified with addresses in Sarasota and Venice, Fla., makes claims on its websites and in its Facebook, Pinterest, Tumblr, Twitter and YouTube postings that render its Fenvir, Prosta Pep and Tonalin products drugs, according to the joint FDA/FTC warning letter published May 26.
The Fenvir product websites states, “This incredible remedy is an advanced and multifaceted herpes treatment that overwhelms and keeps the virus sealed and subdued – helping to keep it from coming to the surface to cause any more outbreaks.”
According to the warning, the Tonalin conjugated linoleic acid product page makes claims including “reduce the incidence of breast cancer, improve asthma, allergy, blood sugar control and diabetes. It even limits atherosclerosis which can lead to heart disease!”
The Prosta Pep page includes the claim “may protect you from getting prostate cancer and may actually help you overcome prostate disease without having to undergo the use of dangerous drugs, debilitating and dangerous surgery, harmful radiation, and catastrophic microwave damage to your tissues.”
Strictly Health makes similar claims for the products in its social media postings, according to the letter submitted by the director of FDA’s Center for Food Safety and Applied Nutrition Office of Compliance and the director of FTC’s Division of Advertising Practices.
The products are unapproved drugs because they are not generally recognized as safe and effective for the label indications and are offered for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners.
Additionally, the Fenvir product is misbranded by the omission of a domestic address or phone number for reporting serious adverse events and by failing to identify the part of the plant from which each botanical dietary ingredient extract it contains is derived.
FTC explains in the Strictly Health warning that in addition to explicit ad claims that are unsubstantiated, “to make or exaggerate such claims, whether directly or indirectly, through the use of a product name, website name, metatags, or other means” violates commission regulations.
While both agencies advise the firm to respond within the standard 15-day period with information on correcting the violations, FTC also notes that its enforcement could extend to seeking a federal court injunction or a cease-and-desist order that could require the firm to pay back money to consumers.
FDA and FTC previously have submitted joint warning letters to firms marketing consumer health care products with claims including treatment for influenza strains and the Ebola virus and others making weight loss claims (Also see "Ebola Crisis Causes Drug Claim Symptoms In Products Marketed As Supplements" - Pink Sheet, 1 Oct, 2014.).