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Dietary Supplements

The majority of adults in the United States take one or more dietary supplements either every day or occasionally and the numbers are growing.  Recent studies have found that more than half of American adults take at least one dietary supplement.

Today’s dietary supplements include vitamins, minerals, herbals and botanicals, amino acids, enzymes, and many other products. Dietary supplements come in a variety of forms: traditional tablets, capsules, and powders, as well as drinks and energy bars. Popular supplements include vitamins D and E; minerals like calcium and iron; herbs such as echinacea and garlic; and specialty products like glucosamine, probiotics, and fish oils.

FDA regulates both finished dietary supplement products and dietary ingredients. FDA regulates dietary supplements under a different set of regulations than those covering "conventional" foods and drug products. Under the Dietary Supplement Health and Education Act of 1994 (DSHEA):

  • Manufacturers and distributors of dietary supplements and dietary ingredients are prohibited from marketing products that are adulterated or misbranded.  That means that these firms are responsible for evaluating the safety and labeling of their products before marketing to ensure that they meet all the requirements of DSHEA and FDA regulations.

  • FDA is responsible for taking action against any adulterated or misbranded dietary supplement product after it reaches the market.

Do you know:

- The difference between a conventional food and a dietary supplement?

- What are the labeling requirements for dietary supplements?

- Registration requirements for dietary supplement manufacturers?

- Is a dietary supplement a food or a drug?

- Are foods that contain nutrients considered to be 'enriched'?

- What is a new dietary ingredient and are there any special requirements     for them?

- Are you compliant with Current Good Manufacturing Requirements?

- What are premarket notification requirements?

- The requirements you need to meet to import your products into the           U.S.?

The nuances around dietary supplements can be daunting.  

  • Are you ready for an FDA inspection?  

  • Are you in compliance with FDA regulations including Current Good Manufacturing Practices?

  • Are your products in compliance with FDA regulations?  

  • Are you considered to be a small entity?  If so, do you know what that means for you?

  • Do your labels meet FDA requirements?  

  • Will your products meet FDA requirements for importation into the U.S.?

  • Do you know how to get off Import Alert?

I have the knowledge, expertise and experience to help walk you through the requirements that affect your firm and your products.  Let me navigate the intricacies for you while you focus on your business. 


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