“Are Nutraceuticals regulated by the U.S. Food and Drug Administration (FDA)?” is the most misunderstood question for the companies operating in the Nutraceutical, supplement, or functional food space. So if you were to ask the question again, here’s the short answer!
YES, but not the same way as pharmaceuticals.
Our team at Elite Recruit LLC specializes in recruiting top sales and commercial leaders for companies based in the nutraceutical contract manufacturing and the ingredient supply space. Understanding how the FDA regulations affect your sales and hiring decisions is a crucial part, as they help international brands enter the U.S. market.
Nutraceuticals vs. Pharmaceuticals: What’s the Difference in FDA Oversight?
The FDA regulates dietary supplements, a different framework from conventional food products. Nutraceuticals are usually part of the category of “Dietary Supplements”, and they are governed by the DSHEA (Dietary Supplement Health and Education Act of 1994.
This means:
Supplements doesn’t require FDA Approval before they head to the market.
Manufacturers are responsible for making sure of the safety of their products and the truthfulness they have to their claims.
The FDA usually steps in after a product officially hits the market, they are lead by warning letters, recalls if non-compliance is found or through inspections.
What the FDA Regulates in Nutraceuticals
Even though pre-market approval isn’t needed, the FDA still has a vital role by regulating:
Labeling & Claims: The structure or the function claims must be not misleading. The disease treatment claims are usually prohibited.
Good Manufacturing Practices (cGMP): Supplement manufacturers must comply with cGMP, FDA standards to make sure of the product quality.
Ingredient Safety: The news Dietary Ingredients (NDIs) must be notified to the FDA, unless they are a part of the food supply already.
Post-market Surveillance: The FDA monitors the event reports and they involve in taking action if a product is found unsafe.
Why This Matters to International Companies Hiring in the U.S.
This is where Elite Recruit LLC can help you with:
We help international CDMOs, functional food innovators, ingredient suppliers to hire U.S-bases sales talent with a deep rooted industry experience, which builds strong networks, and has a basic understanding in:
DSHEA and FDA enforcement trends
Claim substantiation requirements
Regulatory-sensitive selling strategies
Final Thought
Now the U.S Nutraceutical market is booming, but it’s surveyed. And hiring a sales leader who is fluent in both commercial and regulatory language is the smartest move you can ever make.
If you are planning to develop your business in the U.S. and if you need help finding the FDA expert sales candidates, we are here to help.
You can contact Elite Recruit LLC to learn more about how we can support your U.S. growth strategy through high-quality sales and commercial recruitment in the nutraceutical industry.