FDA Label Review

The U.S. Food and Drug Administration (FDA) has made changes mandatory in the „Supplement Facts Panel“ of labels for dietary supplements. The new implementation is expected to cause confusion among consumers.

Some of the updates on labels have been positively received by the industry, notably the daily intake percentages for certain nutrients. Previously, recommended daily intake amounts were based on data from 20-30 years ago. The new update reveals that some nutrients in dietary supplements may actually require more, while others may need less.

FDA has also made changes to additional information on dietary supplement labels and the listing of vitamins and minerals. For instance, information about the daily intake level of added sugars has been added. While vitamins A and C are no longer mandatory, vitamin D and potassium now require specification. The units of measurement for vitamins A, D, and E have shifted from international units (IU) to more familiar units like milligrams and micrograms. There is also a change in the representation of folate, an essential nutrient, which will now be labeled as „folate“ on the labels, presented through „dietary folate equivalents“ (DFE).

The labels of dietary supplements are undergoing visible changes for consumers in the United States. While considered a positive change, manufacturers are advised to be prepared for these alterations.

FDA Coverage

Regulations regarding the labeling and marketing of foods, drugs, and cosmetic products are constantly evolving. Detecting and correcting errors before the intervention of the FDA and FTC is crucial.

• The FTC regulates all forms of advertising.
• The FDA regulates food labeling, cosmetic labels.
• It regulates the content and format of dietary supplement labels and drug labels.

Labels are a specific form of advertising, so both the FTC and FDA are responsible for them. Advertisements on internet marketing sites and other marketing and promotional materials often fall under the legal term „labeling.“ Therefore, the FDA has jurisdiction over them. It’s worth reiterating that the FDA regulates many internet sales as „labeling“ and can send Warning Letters when it detects illegal or unauthorized claims on a company’s website. In cases where the FDA finds a website making illegal claims about a dietary supplement or an OTC drug, it attempts to prevent them from entering the U.S. market. In the worst-case scenario, the FDA seeks assistance from U.S. Customs and Border Protection (Customs) or the U.S. Postal Inspection Service (Postal Inspectors) to track and seize these products.

Designing an appropriate dietary supplement label or a website for the sale of legal and appropriate homeopathic drugs requires knowledge of FDA and FTC rules and compliance with them. Rules regulated by the FDA, whether for cosmetic labels or food labels and functional food websites, are generally considered applicable.

The FDA and FTC hold manufacturers and distributors (importers) responsible for ensuring that necessary label information is easily found and readable, containing disclaimers or warnings needed to keep consumers safe. Manufacturers, importers, and distributors are responsible for ensuring that advertisements and labels (including internet labeling) are accurate and not misleading.

• In 2016, the FDA finalized a decision requiring the updating of the nutrition and supplement declaration sections on product labels to reflect new scientific data. This aimed to enable consumers to make more informed choices. The transition period for this change ended in January 2020, leading to a rearrangement on the shelves.

FDA inspectors and compliance officers regularly review food labeling, cosmetic labeling, dietary supplement labeling, and drug labeling processes when these products are imported into the U.S.

However, the FDA also actively searches online and continually checks for illegal advertisements for products. As soon as the FDA detects illegal advertising, it can inform the necessary authorities to have the product removed from the U.S. market. Therefore, it is crucial to thoroughly examine FDA rules both when labeling and when advertising your product on any platform.