Guest guest Posted August 26, 2008 Report Posted August 26, 2008 Well, yes and no. As with most regulatory matters, it's very complicated and confusing and ultimately not very helpful. When you have a few sleepless nights, feel free to read this one on the FTC's website: http://tinyurl.com/5eykw6 Then, more specifically to dietary supplements: http://tinyurl.com/5lo3wp Note that the FTC governs advertising claims (including statements made on websites) and the FDA governs labeling claims. If you scroll down to Endnotes, #2, it discusses labeling claims and disclaimers. As you can see, this applies to labeling, not advertising. Certain types of claims, but not all, can be made on the label if using the disclaimer Anya was referring to in her recent post. Here's the excerpt: " 2. Under DSHEA, supplement marketers are allowed to make two kinds of claims on labeling: 1) health claims specifically authorized by the FDA; and 2) statements of nutritional support. Health claims — representations about the relationship between a nutrient and a disease or health-related condition — are permitted only if they have been authorized by an FDA finding that there is " significant scientific agreement " to support the claim. The Food and Drug Administration Modernization Act of 1997 (FDAMA) also now allows health claims that are based on " authoritative statements " from certain federal scientific bodies, such as NIH and the National Academy of Sciences. Aside from these authorized claims, supplement marketers are prohibited from making any labeling claim about the diagnosis, mitigation, treatment or cure of a disease. In contrast to health claims, " structure/function " claims, within the broader category of " statements of nutritional support, " refer to representations about a dietary supplement’s effect on the structure or function of the body for maintenance of good health and nutrition. Structure/function claims are not subject to FDA pre-authorization. A marketer may make these claims in labeling if it notifies FDA and includes a disclaimer that the claim has not been evaluated by FDA and that the product is not intended to diagnose, mitigate, treat, cure, or prevent disease. DSHEA also requires that structure/function claims in labeling be substantiated and be truthful and not misleading. This requirement is fully consistent with the FTC’s standard that advertising claims be truthful, not misleading and substantiated. " Yaaaaaaaawn...oh, excuse me... Well, I sure am glad I'm not in that industry. I'd never know what side of the law I was on. Happy reading/snoozing! Patty --- On Mon, 8/25/08, Rachel Markel <ramarkel wrote: Thank you for the information but you still cannot make any claims. Once you do you are now marketing a " drug. " The Federal Trade Commission offers very clear and concise language in regards to this use of words like; antibacterial, antiviral, anti fungal, antimicrobial and so on. Quite frankly, you just don't go there! This is precisely what has given Aromatherapy in the US a very bad rap. Quote
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