Healthcare fraud remains a broad regulatory category that enforcement authorities can use against the manufacturer or distributor of a healthcare product that raises questions in the minds of officials. Even though FDA has indicated greater tolerance for complementary and alternative medicine products, by issuing its permissive draft guidance on low-risk, general wellness products, FDA still maintains a web page on Alternative Medicine Fraud.
FDA notes on this page that examples of alternative medicine include: homeopathic medicine, traditional Chinese medicine, and Ayurvedic medicine. Alternative medicine fraud remains an FDA staple, since FDA retains the category and mentions it under the umbrella of healthcare fraud.
FDA includes on this page a number of warning letters against companies that promoted alternative medicine products. Many of these are archival. For example, in 2009, FDA advised consumers not to use certain Zicam cold remedies; FDA also warned consumers against loss of smell associated with certain intranasal cold remedies containing zinc.
One of the warning letters that involved traditional Chinese medicine related to promoting herbal teas to prevent H1N1 swine flu. Another addressed Ma Huang (ephedra).
FDA’s warning to consumers regarding Ayurvedic products mentioned concerns about heavy metals in some Ayurvedic products.
Key in any lawful promotion of a dietary supplement is the distinction between a legal, structure/function claim, and an unlawful disease claim. FDA regulations outline at least 10 ways a dietary supplement product can make a disease claim, including:
- Product name that incorporates a disease claim (such as, for example, “Cancer Away”).
- Citation of a publication or reference that refers to a disease use.
- Use of the term “disease” or mention of a disease.
- Product marketing that compares the performance of the dietary supplement to a legally marketed drug or purports to substitute for the drug.
- Otherwise suggests an effect on disease.
There is also another category of claims known as health claims, which describe the relationship between a food substance and reduced risk of a disease or health-related condition.
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