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

More Resources

De Novo Classification

De Novo Classification

A device can be registered for the De Novo pathway if there is evidence of the safety and effectiveness of the device and there is not a previously legally marketed predicate device1. When determining if your device can go through the De Novo process there are two pathways available to determine the device classification.
Abbreviated 510k submission

Abbreviated 510k submission

There are three types of 510K, Premarket Notifications, which can be submitted to the Food and Drug Administration (FDA) traditional, abbreviated, and special. Abbreviated and Special 510K submissions can be utilized when the submissions meet the certain factors presented by the FDA. When submitting an abbreviated 510K the submission must include the elements that are identified in 21CFR 807.87 for the information required in a premarket notification submission.
Is your product a medical device?

Is your product a medical device?

Many marketed products are classified as medical devices and you would not even know it. Medical devices range from latex gloves and tongue depressors to respirators and heart valves. To determine if the product is considered a medical device by the Food and Drug Administration (FDA) you will need to analyze if your product meets the definition of a medical device per the Food, Drug, and Cosmetic Act1.

Ready to learn more about working with us?

Pin It on Pinterest

Share This