Fda Dietary Supplement Disease Claims
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Food And Dietary Supplement Package Labeling Guidance From Fda S Warning Letters And Title 21 Of The Code Of Federal Regulations Brody 2016 Comprehensive Reviews In Food Science And Food Safety Wiley Online Library
Cfr Code Of Federal Regulations Title 21
A dietary supplement.
Fda dietary supplement disease claims. A low calorie claim may not be made on dietary supplements except when an equivalent amount of a dietary supplement that the labeled dietary supplement resembles and for which it substitutes e. A health claim nutrient content claim or structure function claim. There are three ways in which fda exercises its oversight in determining which health claims may be used on a label or in labeling for a conventional food or dietary supplement.
The fda provides little guidance in terms of examples of acceptable and unacceptable claims on this type of disease claim. If the label or labeling of a product marketed as a dietary supplement bears a disease claim as defined in paragraph g of this section the product will be subject to regulation as a drug unless the claim is an authorized health claim for which the product qualifies. But one may gain insight by following the news about warning letters to dietary supplement brand owners.
1 the 1990. A claim that a dietary supplement will augment a particular therapy or drug action that is intended to diagnose mitigate treat cure or prevent disease is a disease claim. Health claims describe a relationship between a food food component or dietary supplement ingredient and reducing risk of a disease or health related condition.
Just as fda sought to prevent medical foods from expanding into drug territory so too would fda curtail dietary supplements claims. Substantiation for dietary supplement claims although fda eschews a particular formula for the number and type of studies required to substantiate a claim it suggests that advertisers consider. Fda does not require.
It is not legal to market a dietary supplement product as a treatment or cure for a specific disease or to alleviate the symptoms of a disease. Fda is likely to interpret the dividing line between structure function claims and disease claims in a similar manner for conventional foods as for dietary supplements. Companies seeking to rely on the section 343 r 6 exemption would at minimum need to prove through credible science that the nutrient deficiency is the exclusive cause of a disease in order to assert the exemption.
There are limitations to fda oversight of claims in.
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