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 a 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 the exports of your supplements.
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 supplements 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.
How We Help
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Expert knowledge of FDA regulations that helps you strategically grow your business
We retained Marc to answer some extremely time-sensitive and complex questions regarding COVID-19 and FDA regulations. Despite being overloaded with clients, Marc was very responsive and was able to provide us with the comprehensive answers we needed within 24 hours. This enabled us to respond quickly and effectively to the changing regulatory landscape. I strongly recommend using Marc and look forward to working together again in the future.
Marc Sanchez has provided our company with expert advice and letters that have saved us time and money in dealing with the FDA. We have worked with many FDA attorneys and consultants in the past and they can't hold a candle to the knowledge and expertise that we have found with Marc.
Jeff Maier (VP Sales & Marketing)
Marc is incredibly intelligent, poised and able to make reasonable, timely recommendations about risk. Additionally, he is extremely organized, has a calm demeanor and has provided insightful counsel to me on many regulatory issues. I strongly recommend him.
Physician- Entrepreneur- Consultant
I am truly impressed… Marc understands the workings of the regulatory agencies and this allows him to very effectively achieve the results that his customers want without creating an environment of confrontation. Beyond that, he has insight into the laws governing foods, supplements, and medicine that goes beyond that of the federal officials involved in these regulatory areas. This allows him to open avenues of compromise and agreement that would not have existed before he was brought to bear on the difficulty. Even as he produces compromise and agreement, it is clear that he holds his customer's interest at heart.
I have never found a more powerful and effective counsel.