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FDA official sheds light on dietary supplement working group

FDA tainted supplements 2019

In December, FDA announced the formation of a working group to improve oversight of the dietary supplement industry. The industry immediately wondered about the working group’s participants and objectives, including whether it would make substantive changes affecting dietary supplements without outside input.

In an interview, an FDA official explained the internal working group is focused on improving the agency’s internal processes and procedures, and he emphasized FDA would continue to solicit input from stakeholders on substantive policy changes.

The working group is “a simple self-reflection and acknowledgement that we have an obligation as an agency to make the best use of the resources and the authorities that we have,” said Steven Tave, director of FDA’s Office of Dietary Supplement Programs.

Since passage of the Dietary Supplement Health and Education Act of 1994 (DSHEA), the “market has evolved,” and FDA must ensure it has “evolved appropriately,” Tave added in a phone interview.

He suggested it is time to examine practices and procedures that his agency established long ago. For example, Tave noted, depending on a variety of factors, a product that contains an ingredient FDA has determined doesn’t belong in dietary supplements could fall under the jurisdiction of two different entities at FDA: the Center for Food Safety and Applied Nutrition, or the Center for Drug Evaluation and Research.

“When you have these products that label themselves as dietary supplements but actually contain unlawful drug ingredients … [under the law] that takes them out of the definition of dietary supplement and takes them out of the definition of food,” Tave explained. “Within FDA operationally, that makes them drug products, so what’s happening is we’re splitting up authority internally over the commodity.”

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NutraCap Labs’ mission is to provide our customers with the highest quality products and an industry-best customer service experience. Based in Atlanta, GA, NutraCap Labs is a manufacturer of Nutraceuticals/Dietary Supplements and we are experiencing explosive growth. As a GMP compliant and an FDA registered company, we specialize in encapsulation manufacturing, sports nutrition and raw health powders, product formulation, brand design and distribution. Private Label manufacturing is the fastest growing sector of our business and our biggest strength due to the relationships we have built with our customers.

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At Nutracap Labs we aim to lower what has always been a high barrier to entry into the dietary supplement industry. Our minimums start at 144 units per product and allows lower risk for two categories of customer. 1. Those who may be working with limited capital and cannot tolerate much risk. 2. Those who have the capital but are interested in testing the market before they scale their business

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