Non-Compliant Workaround #12: implying a disease claim by suggesting that the product treats, prevents, or mitigates adverse events associated with a therapy for a disease and manifested by a characteristic set of signs or symptoms.
Are the side-effects of chemotherapy a disease? You betcha, so treating diarrhea after taking antibiotics or nausea while on chemotherapy are considered treating a disease and you can’t say that. Again, none of these rules have anything to do with what an herbal formula can do, only with what you claim that they do. Strange but true.
When making a structure / function claim online, in print, or inserted into your product packaging, you have thirty days to notify the FDA of this claim. It appears that if there is no claim made, that this notification does not need to take place. That can simplify things somewhat, perhaps I should have mentioned that earlier. :)
There are few clear instructions on what this notification needs to include. The FDA says:
Sec. 190.6(b)(4) states that the manufacturer or distributor is not required to do a complete literature search. It is required only to provide “the basis on which it has concluded that a dietary supplement containing such dietary ingredient will reasonably be expected to be safe” (section 413(a)(2) of the act). That is all that the regulation requires.
The FDA describes their substantiation requirements as:
tests, analyses, research, studies, or other evidence based on the expertise of professionals in the relevant area, that has been conducted and evaluated in an objective manner by persons qualified to do so, using procedures generally accepted in the profession to yield accurate and reliable results. [Source]
That’s really not very good news as most of our formulas have not been tested by these standards, though of course there is more than ample testing done in China, Korea, Japan, etc. However English speaking practitioners may not have access to such information to be used as substantiation.
Violations of the DSHEA can result in fines, seizures of product, and incarceration. [source]
Of particular interest to the FDA are products that address the following conditions:
Treatment of life-threatening illness
Supplements for alcohol drinking