How Does the FDA Regulate Dietary Supplements?
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How Does the FDA Regulate Dietary Supplements?
One of the biggest misconceptions about the dietary supplements industry is that it is not regulated.
In reality, nothing could be further from the truth!
In this video, Blayney McEneaney, Vice President of Sales for NutraScience Labs, and Gene Bruno MS, MHS, RH(AHG), Vice President of Formulation and Regulatory Affairs for NutraScience Labs, discuss who regulates dietary supplements, why aspiring brand owners should not be intimidated to enter the dietary supplement industry and the role that a qualified supplement contract manufacturer plays in this process.
Some of the topics, questions, and myths Blayney and Gene will address in this 30-minute video include:
Who Regulates Dietary Supplements? [1:15]
DSHEA or the Dietary Supplement Health and Education Act of 1994 is a piece of legislation that defines and regulates dietary supplements. Under this act, dietary supplements and vitamins are regulated by the FDA for Good Manufacturing Practices (GMPs) under 21 CFR Part 111.
It’s also important for brand owners to know that DHEA is not a static piece of legislature. In fact, it is updated quite often. A perfect example is the recent changes that were made to the labeling guidelines for dietary supplements.
What Kinds of Claims Can I Make On a Vitamin Supplement Label? [3:45]
One area of DHEA that is important for dietary supplement brand owners to understand is structure-function claims. Specifically, what kind of claims can you make on the label of your product?
As an example, you cannot say that glucosamine helps reduce joint pain because that is a drug claim. Alternatively, you can say that glucosamine promotes joint comfort.
If you’re not sure where to begin, a regulatory lawyer or an experienced dietary supplement contract manufacturer can provide the necessary guidance to ensure your product is not making any claims that would cause your product to be pulled from the market.
Are Vitamins Regulated by the FDA? [13:48]
In spite of the enormous amount of misinformation out there saying otherwise, the vitamins and supplements industry is heavily regulated by the FDA. In fact, there are 10 different laws and groups of regulations surrounding dietary supplements, how they’re to be sold, etc.
However, the FDA does NOT have a process for approving dietary supplements. Any vitamin or supplement product that claims to be FDA approved or uses the FDA logo on their website and/or product label should be avoided. Brands cannot use the FDA’s logo in any way, shape, or form.
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Articles Referenced in This Video:
– FDA Changes Guidelines for Labeling Dietary Supplements: https://www.nutrasciencelabs.com/blog/7-fda-changes-coming-to-your-nutrition-facts-label
– 10 Dietary Supplement Regulations Brand Owners Cannot Ignore:https://www.nutrasciencelabs.com/blog/10-supplement-industry-regulations-new-brand-owners-cant-ignore
– How to Create a Dietary Supplement Formula:
https://www.nutrasciencelabs.com/blog/how-to-create-a-dietary-supplement-formula
– The Legal Aspects of Starting a Dietary Supplement Company:
https://www.nutrasciencelabs.com/blog/legal-aspects-of-starting-a-supplement-company
— Get More Expert Insights from NutraScience Labs:
https://www.nutrasciencelabs.com/blog
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