Supplements

Meet strict regulatory requirements while taking your dietary supplement products to the next level

Many organizations — big and small — make the mistaken assumption that the FDA doesn’t regulate dietary supplement packaging and marketing. Take note that the FDA does, in fact, regulate functional foods, fortified food and drinks, dietary supplements, and natural remedy products sold in the United States.

Did you know that the FDA has recently started to increase its enforcement efforts against companies that violate the regulations? That can result in Warning Letters, recalls, and more.

Be sure your dietary supplement company meets the FDA regulations so you can continue growing your business. Here’s how FDA Atty helps:

Label review: Your supplement labels need to include details such as statement of identity, net quantity of content, and ingredient information, presented in a specific format. We ensure that you have the right information — like health, structure/function, and nutrient content claims — written in the correct format. We can also help you file a 30-day Structure/Function Claim Notification with the FDA.

Advertising review: What you can and cannot say on websites, social media, point-of-purchase material, third-party testimonials, and other marketing mediums is regulated by the FDA and Federal Trade Commission (FTC). We ensure your content is compliant while showcasing your unique supplement product.

NDI: Consumers and large retailers want to know if your ingredients are recognized as dietary ingredients or require a New Dietary Ingredient (NDI) notification. FDA Atty can complete an ingredient review or file an NDI notice with the FDA.

Adverse event reporting and record keeping: If any adverse events related to your supplements occur, they need to be reported to the FDA. We help clients establish standard operating procedures so you can clearly identify and report the event, as well as train staff to properly monitor, and conduct compliance audits.

Export certificates: Worried you don’t have the right export form? We can help ensure your paperwork is in place so there are no hiccups during your export.

Import alerts: If your supplement product is detained at the border, your company could end up on an import alert listing — which is a public notice of violation. We ensure you avoid getting into this situation. If you’ve already received an import alert, FDA Atty can petition the FDA for removal, so you can get back to business.

Warning Letter and border detention assistance: Don’t panic if your products are stopped at the border or if you receive a Warning Letter. With FDA Atty, you can request the FDA to fix the issue so you can avoid destroying your inventory. Time is of the essence, so act fast.

Other services: We can also help your supplement business interpret the scope of relevant regulations, advise during product recalls, and ensure your manufacturing processes are compliant. Don’t hesitate to ask whether FDA Atty can assist with any regulatory issue.

Don’t let FDA regulations stop you from running your business. Work with an expert to ensure your business is compliant in every area.

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