FDA and Dietary Supplements

by | Jul 31, 2019 | Clinical Trials, FDA, Medical Devices, Quality Systems, Regulatory, Requirements

The $40 billion dietary supplement industry is still growing making it a market you may want to take advantage of, but FDA’s oversight of these products is also increasing1.

FDA currently regulates dietary supplements Under the Dietary Supplement Health and Education Act of 1994 (DSHEA)2. They are working to modernize this regulation but both manufacturers and distributors of dietary supplements are still responsible to ensure the safety and labeling meet the standards, and FDA can and will take action against any adulterated or misbranded dietary supplement1.

In order to avoid enforcement actions, it is imperative to not make any unsubstantiated claims. Dietary supplements are not regulated like drugs, because they are not intended to treat, diagnose, prevent, or cure diseases. Claiming a supplement contains antioxidants or no sugar can be supported and can be made3.

FDA has a guidance document regarding labeling as well. For example, it is required to state the ingredients and their “% Daily Value” on the label. Any ingredients without an established % daily value are to have “Daily Value not established” indicated. FDA also states that the labels are to be presented in a way that is similar to all food as a form of standardization for the consumer4.

Another requirement for dietary supplements is that they must be manufactured in a factory using current Good Manufacturing Practices. These require proper controls to ensure supplements are processed in a way that consistently meets quality standards. Quality standards include containing the correct amount of the correct ingredients, no foreign material present, packaged and labeled properly5.

FDA is continuing to update their guidances to ensure consumer safety is put first. However, this doesn’t mean that they are becoming clearer for those manufacturing and distributing dietary supplements.

Contact us at 248-987-4497 or info@emmainternational.com to see how we can help you with complying with the dietary supplement requirements.

1 FDA STATEMENT retrieved on July 25, 2019, at https://www.fda.gov/news-events/press-announcements/statement-fda-commissioner-scott-gottlieb-md-agencys-new-efforts-strengthen-regulation-dietary.

2 FDA Dietary supplements retrieved on July 24, 2019, at https://www.fda.gov/food/dietary-supplements

3 FDA Small Entity Compliance Guide retrieved on July 25, 2019, at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/small-entity-compliance-guide-nutrient-content-claims-definition-high-potency-and-definition.

4 FDA Small Entity Compliance Guide retrieved on July 25, 2019, at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/small-entity-compliance-guide-statement-identity-nutrition-labeling-and-ingredient-labeling-dietary.

5 FDA Dietary Supplement Current Good Manufacturing Practices (CGMPs) and Interim Final Rule (IFR) Facts retrieved on July 25, 2019, at http://wayback.archive-it.org/7993/20170111070358/http://www.fda.gov/Food/GuidanceRegulation/CGMP/ucm110858.htm.

Jayme Brace

Jayme Brace

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