Now Trending: Consumer Awareness & Supplement RegulationNow Trending: Consumer Awareness & Supplement Regulation
Kathleen Dunn says more consumers—gasp!—realize that supplements are actually regulated.
December 18, 2014
As 2014 comes to a close, one trend that I am happy to see … thrilled actually … is the growing consumer awareness that dietary supplements are indeed regulated.
For those of us who work in the industry, we know success demands that we not only understand the rules of the road, but also apply them properly.
We know the Food and Drug Administration (FDA) has full authority to pounce if product labels are out of compliance, if product safety is a concern, or if manufacturing quality is suspect. There is no shortage of regulations on the books telling us just what we can and cannot do from the Dietary Supplement Health and Education Act (DSHEA) to current Good Manufacturing Practices (cGMPs) to Adverse Event Reporting (AER) and beyond.
We also know the Federal Trade Commission (FTC) can–and should–take a company to task when product advertising is false and misleading. After all, consumers deserve quality products with truthful claims backed by sound science.
Of course, when it comes to regulatory agencies that govern the sale of dietary supplements in the United States, the FDA and FTC are the biggies. But other federal and state regulatory agencies – U.S. Department of Agriculture (USDA), the Environmental Protection Agency (EPA), state attorneys general and state-level food and drug agencies, among others – also play a role in ensuring that supplements sold in the marketplace are safe, effective, quality products.
Don’t follow the rules, and the various regulatory agencies spring into action. Warning letters are written. Products are seized. Penalties are levied. Companies are shut down. It’s a complex regulatory machine designed to protect consumers.
Yet, many consumers still have doubts. So when I see any efforts to make the regulatory oversight of our industry more transparent for them, it certainly makes me smile.
In 2014, we saw one such effort courtesy of the Council for Responsible Nutrition (CRN) and the launch of their FDA Warning Letters Database for Dietary Supplements. It’s a searchable database of letters to companies that are out of compliance. You can search by product, company, or ingredient or do a tailored search. The search results even include links to the FDA’s specific concerns and required corrective actions.
While the database is primarily intended to provide industry with examples of non-compliant issues, it serves a broader function. You see, I hesitate to send consumers to the FDA’s website to find warning letters. Sure, the information is there, but it can feel like a Herculean effort to find exactly what you need. Consumers are likely to find using the CRN database a much more inviting experience.
In fact, I would lobby that the real value of the database is to help clear up consumer confusion and provide yet one more example that, yes, dietary supplements are regulated. And, that’s a welcome trend.
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