The American dietary supplements market remains strong, but due to U.S. Food and Drug Administration rules for dietary supplement labeling, moving products to market and placing them on store shelves is a cumbersome process. Even a slight slip up can lead to warning letters, fines, and penalties, while importers can be hit with product detention and other costly complications.
Sellers need to have a clear understanding of dietary supplements marketing, says regulatory expert Norma Skolnik, and that means being up on the latest agency guidance. Skolnik covers topics like ingredient requirements, labeling requirements, and recent updates for dietary supplement labeling in her webinar for Audio Educator, “FDA Regulations for Marketing Dietary Supplements: Latest Updates.”
Agency Rules Clearly Delineate Where Label Statements Must Go
The FDA spells out labeling and marketing rules in its “Dietary Supplement Labeling Guide,” and they include everything from understanding the definition of supplements to where the required label statements should be placed and what size, prominence, and conspicuousness are required.
For the purposes of the FDA, dietary supplements include products which supplement a diet and include one of more of the following ingredients:
- A vitamin
- A mineral
- An herb or other botanical
- An amino acid
- A dietary substance used to supplement the diet by increasing total dietary intake
- A concentrate, metabolite, constituent, extract, or a combination of any of the above
The agency says required label statements must either be on the front panel (the principal display panel) or the information panel (usually the label to the right of the front label). The principal display panel must have the net quantity of contents while the information panel must include the “supplement facts,” which includes the ingredient list and the name and place of business of the manufacturer, packer, or distributor.
Without a Comment Period, Updates Went into Effect Immediately
The FDA’s latest updates for nutrition and supplement facts labeling arrived on Dec. 21, 2018.
“Since we published the two final rules in the Federal Registers, we have noted or have been made aware of errors that appeared in the final rules,” the Dec. 21 update states.
Most errors are minor, the updates add, while some highlight inconsistencies between the Nutrition Facts Label Final Rules requirements and sample labels. Overall, the agency highlighted changes to statements concerning:
- Cross-referencing
- Saturated fat, trans fat, polyunsaturated fat, and monounsaturated fat
- Fiber
- Added sugar
- Quantitative weight and retinal activity equivalents
- Type size
- Spelling corrections
The rule changes were not accompanied by a comment period since they were only technical, and they went into effect immediately, explains the National Law Review.
Meanwhile, the FDA recently stated that Jan. 1, 2022 will be the uniform compliance data for final food labeling regulations issued in 2019 and 2020.
“All food products subject to the 2022 uniform compliance date must comply with the appropriate labeling regulations when initially introduced into interstate commerce on or after Jan. 1, 2022,” explains the Natural Products Insider. “This action does not change existing requirements for compliance dates contained in final rules published before Jan. 1, 2019.”
All labeling issues, no matter how seemingly minor they are, must be adhered to closely, says Norma Skolnik in her webinar. Armed with the latest knowledge, you will be better placed to market dietary supplements in the U.S. without coming into conflict with any FDA norms and regulations.
