Dietary Supplements | Labeling Requirements

The Food Drug and Cosmetic Act (FDCA) requires the dietary supplement label to include certain mandatory labeling elements, such as a correct dietary supplement statement of identity and a Supplement Facts table, rather than the Nutrition Facts table that is required for conventional food labels.

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A dietary supplement is misbranded when its label does not include all required labeling information in the proper placements, print sizes and fonts, and formats. Most of the errors that foreign dietary supplement manufacturers make are in designing the Supplement Facts table and in creating legal dietary supplement label claims. There are very specific FDA regulations that govern when traditional nutrients may (or must) be declared on a dietary supplement label in comparison with dietary ingredients for which FDA has not established a recommended daily intake or daily value.

In addition, the names of the dietary ingredients (in the ingredient list or in the Supplement Facts table) are strictly governed by FDA regulation and very often dietary supplement importers and distributors declare their ingredients incorrectly.

However, probably the single most common error is when a dietary supplement manufacturer, distributor or marketing company uses implied or explicit drug claims in their dietary supplement labels or dietary supplement Internet marketing websites, or they make claims that are false or misleading because of the way the claims are drafted. These errors can have very costly consequences, including FDA regulating the products as drugs instead of as dietary supplements (applying all of the more rigorous FDA regulations related to drug products) or the Federal Trade Commission (FTC) initiating an investigation or other enforcement action based upon unfair trade practices.

Under the FDCA, FDA has exclusive jurisdiction over dietary supplement safety, and primary jurisdiction over the dietary supplement labels. The Federal Trade Commission (FTC) has primary jurisdiction over dietary supplement advertising.

Under the Dietary Supplement Health and Education Act of 1994 (DSHEA), dietary supplement labels may bear general health and well being claims and structure or function claims. However, the person marketing a dietary supplement with such claims in dietary supplement labeling must submit a Structure Function Claim Notification to FDA identifying the claims that are used in connection with the dietary supplement. Under FDA law and FDA regulations, generally, dietary supplement Internet marketing websites fall within the FDCA definition of the term dietary supplement "labeling", bringing the websites within FDA jurisdiction.

FDA routinely reviews and evaluates websites that market dietary supplements looking for implied or explicit claims that a product can cure, mitigate, treat, or prevent a disease (these are called drug claims, because they may only appear on drug labeling and may not appear on dietary supplement labeling). However, the line between an improper and illegal drug claim and a permissible structure or function claim can be very thin. For instance, a claim that a dietary supplement helps establish and maintain normal blood sugar levels will be interpreted by FDA as an implied disease claim (related to diabetes). However, if the claim includes the qualifier that its effect is achieved only in healthy individuals, it could be a permissible function claim. As you can see, it can be easy to accidentally cross over into a drug claim, and as a result FDA and FTC would both consider the product a drug which bears false and misleading advertising claims.

FDAImports.com, LLC spends a lot of its time assisting dietary supplement distributors and marketers, as well as dietary supplement importers and foreign manufacturers, in designing compliant dietary supplement labels and crafting legal dietary supplement Internet marketing and label claims. In this way, FDAImports.com, LLC makes clear The Way Through to the high value U.S. dietary supplement industry. FDAImports.com, LLC routinely reviews dietary supplement labels for FDA compliance and dietary supplement Internet marketing websites for FDA and FTC compliance. Because it is a highly regulated industry, FDA is always looking for dietary supplements that are being marketed as drugs (with disease claims) in order to stop the marketing and the products, particularly before such dietary supplements are imported into the United States.

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At FDAImports.com, LLC we make certain our importing clients understand the importation process and assist our clients in identifying appropriate actions and responses should Customs demand redelivery of a conditionally released product, or should that agency issue a demand for payment of liquidated damages pursuant to the importation bond. It is important for your company to know and follow the laws, regulations, and procedures when importing products into the United States. Get Started.