FDA Releases New Draft NDI Guidance; FDA Warns for Trade-Show Literature; President Signs GMO-Labeling Bill

The latest top stories for the sports nutrition / dietary supplement industry:

FDA Releases New Draft New Dietary Ingredient Notification Guidance

Today, FDA announced the release of its new, draft New Dietary Ingredient (“NDI”) guidance document, which replaces its previous, July 2011 draft. Please stay tuned for updates as we digest this lengthy new guidance.


FDA Warns for Disease Claims on Trade-Show Literature

In a warning letter dated July 22, FDA warned J&E International Corp for allegedly making disease claims on its website and in trade-show literature. Disease claims cause the products to be drugs. Here, FDA cited statements including “Anti-inflammatory” and “Clinically improves cognitive function (Alzheimer’s disease, vascular or mixed dementia)” as disease claims. And notably, FDA wrote “claims made in your promotional material distributed at the 2016 Natural Products Expo West trade show that was held on March 9-13, 2016, at the Anaheim Convention Center provide evidence that your products are intended for use as drugs.” With the Mr. Olympia Expo and Supply Side West swiftly approaching, it’s an excellent time for a review of your supplement company’s ad copy. After all, FDA may soon be scrutinizing your claims at your expo booth!


President Signs GMO-Labeling Bill

On July 29, President Obama signed a bill implementing a bioengineered food labeling standard. This law preempts Vermont’s (and other states’) GMO law, which had gone into effect on July 1, 2016. One significant provision of the federal law allows food distributors to electronically link to GMO disclosures, rather than placing a statement directly on the label. For example, a company may opt to disclose the presence of GMO ingredients in the food by printing a QR code and the words “Scan here for more food information.” A customer who scans the QR code on his or her smartphone would be brought to a website with information on the food’s GMO content. The law leaves many details for the U.S. Department of Agriculture to develop in the coming years.


In today’s regulatory climate, where FDA, FTC, state attorneys general, industry self-regulatory organizations, class action lawyers, and even individual U.S. Senators are leading a patchwork of crusades against dietary supplement companies, it is vital to keep up to date with the latest enforcement efforts and trends. We regularly send out emails summarizing the latest enforcement actions (opt in; we never share our subscription list, and you can opt out at any time at the bottom of each email). Please share them! Learning from others’ mistakes is cheaper than learning firsthand what kinds of practices and violations lead to enforcement.

If you have a dietary supplement or cosmetics company and have any questions about your responsibilities under the law, including label claims, labeling requirements, advertising review, Good Manufacturing Practices, or anything else, give us a call anytime at 516-294-0300.