What Companies and Professionals Should Know
You could be a Brand Owner, a contract manufacturer, or even a sales leader in the nutraceutical space. You might have likely wondered,
“Are nutraceuticals regulated by the FDA?”
In short, the answer is Yes, but it is never the same as Pharmaceuticals!
Well, let’s break it down!
What the FDA Regulates in Nutraceuticals?
FDA doesn’t always approve dietary supplements before they go to the market; they are totally different when compared to drugs. But it does regulate them under the Dietary Supplement and Education Act of 1994. This also means:
Manufacturing Standards: Companies must proceed with cGMP for safety, quality, and consistency.
Labeling Accuracy: The presented Labels must be truthful, it shouldn't mislead, and must have insights into the ingredients, disclaimers, and directions.
Claims Regulation: You can make structure or functional claims, but you can't claim your supplements treat or prevent any diseases.
FDA Oversight: The FDA has the authority to take action warning letters and imposing fines, if the products are misbranded or if they contain unapproved ingredients.
Note: If you are selling or making supplements, you are responsible for your product’s compliance.
How About Novel Ingredients?
It is a great question!
If you are one of those who use new dietary ingredients (NDIs), you may have to notify the FDA and also submit safety data.
Failing to do this is the biggest regulatory issue that is seen in the industry.
Learn more about FDA’s Dietary Supplement Guidelines here
What Companies Must Do
Whether you’re a brand or a CMO, these are the basics:
Proceed with the GMP certifications (UL, FDA-audited, and so on)
Keep up with Batch records and testing protocols.
Double check with the labelling and claims compliance
Keep a handle on your supply chain.
Are you in need of hiring professionals who can understand the FDA regulations related to QC/QA and Compliance?
See how Elite Recruit helps supplement companies hire smarter
What Professionals Should Know Now?
If you are in the Nutraceutical space as a QA, R&D, or Sales leader or Regulatory, then you must keep track of these things:
Your understanding of FDA regulations can make you even more valuable.
Brands seek candidates with industry-level experience to navigate the GMP audits, FDA interactions, and, of course, labeling reviews.
DSHEA Knowledge or working with GRAS submissions or NDIs can give you a competitive edge
Having DSHEA knowledge or working with NDIs or GRAS submissions gives you a competitive edge.
Looking for your next role in a GMP-compliant company?
Explore open roles in the supplement and contract manufacturing space
Final Thoughts
So, in short to answer your question are nutraceuticals regulated by the FDA? The answer is Yes! But not like drugs!
After all, most people confuse the Nutraceutical and Pharmaceutical industries, though there’s a lot to discuss if we were to talk about their differences.
The focus is to prioritize labeling safety and the post-market enforcement, which summarizes:
Companies must stay compliant
Professionals must stay updated..
If you are hiring or seeking a job in the Nutraceutical industry, it requires a recruiter who can understand the FDA-regulated environment.