On February 26, 2015, the U.S. Food and Drug Administration (FDA) issued warning letters to nine manufacturers of products sold over the Internet, informing each that they improperly advertise their products with disease-related claims.
Focus on dietary supplements
Five of the targeted companies manufacture foods or dietary supplements. The FDA’s recent actions signal its ongoing belief that misinformation is a pervasive problem on the Internet, and that while millions of consumers have used the Web successfully to gather valuable information about the latest treatments, drugs and medical research, consumers may be especially vulnerable when it comes to false or exaggerated claims about health products.
The drug claims at issue
The claims targeted by the FDA’s recent action include those concerning the following:
- A “cancer herb tea,” that its maker claims “can help kill those cancer cells.” See FDA Letter to Antonio Jimenez.
- Hemp oil treatments, some of which are advertised as having antipsychotic, anti-cancer and anti-depressive properties (“combats psychosis [and] neurodegenerative disorders” .. . “combats tumor and cancer cells” [and]”combats…depression disorders”). Another of these is advertised as having “documented capabilities as an . . . antipsychotic . . . vasorelaxant (lower blood pressure), antispasmodic, anti-ischemic, anti-cancer agent . . . antibacterial agent, anti-diabetic . . ..” A third is claimed to “reduce or inhibit cancer cell growth in six cancers with breast cancer leading the list.” See e.g., FDA Letter to Hemp Oil Care.
- “Curaderm BEC 5 Cream” which its maker asserts is “[c]linically proven to eliminate non-melanoma skin lesions, including actinic keratosis, sunspots, basal cell carcinoma and squamous cell carcinoma”; and “Tamanu Oil”, which its maker claims is “believed to have wonderful skin healing, anti neuralgic [sic], anti-inflammatory, antimicrobial, antibiotic, and antioxidant properties.” See FDA Letter to Infiniti Creations, Inc.
- “Bone knitting powder” which its maker recommends for “the use of bone fractures, dislocations, torn or damaged ligaments, such as neck, ACL or Medial Collateral Ligament . . . .” and as “promot[ing] circulation, prevent[ing] atrophy, repair[ing] damaged tissue . . . strengthens and heals broken bones . . .” See FDA Letter to Modern Herb Shop Inc.
- A “nanobiotic” which its maker claims has been “shown in published cardiology studies to reverse/regress atherosclerosis, calcified coronary artery plaque volume … and eliminate heart disease symptoms.” See FDA Letter to NanoBiotech Pharma, Inc.
- Nutraceuticals claimed to “kill certain types of Liver, Colon cancer, Ovarian cancer, breast cancer cells. High blood pressure, cure various kinds of diseases, Heart problems,…Leprosy, Dysentery…” See FDA Letter to NUTREGLO Products Inc.
The FDA concluded that because these manufacturers claim their products are “intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or intended to affect the structure or any function of the body,” the products are “drugs” under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (FDCA). Furthermore, the FDA determined that the products were “new drugs” under section 201(p) of the Act, because they are not generally recognized as safe and effective. New drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from the FDA, as described in section 505(a) of the Act.
FDA scrutiny will continue
That these warning letters largely targeted supplement manufacturers highlights the fact that the supplement and “nutraceutical” industry has boomed in recent years. It also points out that it remains relatively easy for some companies to get into the business of marketing and selling these products, particularly through Internet advertising.
The FDA’s current enforcement actions suggest that its focus on ensuring that such products are not improperly advertised with drug claims continues unabated.