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 increasing...

1. FDA and Dietary Supplements
By: Jayme Brace
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.

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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.