Industry Self-Regulation and FDA Ensure Dietary Supplement Safety & Quality


By James Gormley via

If retailers ask their customers about dietary supplement safety, they’re bound to get a variety of responses, especially considering that quality and safety often go hand-in-hand.

In terms of quality, Vitamin Retailer magazine’s 2007 Annual Retailer Survey showed that the percentage of retailers who identify “high quality” as the most important element of their store’s success nearly doubled from the previous year—from 13.9 percent to 27 percent.

While a 2008 survey sponsored by the Council for Responsible Nutrition (CRN) tells us that over 80 percent of American consumers are confident that they are buying high-quality and safe dietary supplements, bad press is likely to discourage potential, fence-sitting shoppers from hopping off that fence and going into their favorite health food store, especially if yet another scientific study has just been misrepresented by researchers or misreported by media.

In the meantime, global anxiety about tainted or contaminated ingredients and products is now at an all-time high, fed in part by product contamination crises traced, in some cases but not all, to suppliers from China.

Industry Self-Regulation Ensures Quality

Amidst these concerns, important industry self-regulatory efforts are sometimes lost in the shuffle. For example, although it may not have been considered a “sexy” enough topic for CNN Headline News, in July 2007 the Natural Products Association (NPA) announced a new program for testing Chinese raw materials for purity and composition. Under the new program, raw materials used in the most common dietary supplements will be tested in the U.S. Pharmacopeia’s (USP) Shanghai, China laboratory.

“The combination of the new FDA rules and the testing program will greatly strengthen quality assurance and consumer confidence,” said the NPA’s David Seckman. “It’s really a one-two punch to keep America’s dietary supplement supply safe, effective and of the highest quality.”

Working to ensure quality is not new to the NPA, of course. Since 1990, NPA (then the NNFA) has been running its TruLabel Registration and Random Testing Program. Under this program, supplement makers’ products are randomly selected for analysis to see if the label matches what’s in the bottle.

In addition to this, the Natural Products Foundation (begun by the NPA) offers a product testing program as well. According to the foundation: “This program not only helps your company attest to its commitment to quality products, but helps raise the bar for the industry as a whole and communicate a positive message about the integrity of dietary supplements.”

So what’s the real deal about dietary supplement safety?

Both the U.S. Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) have regulatory authority over dietary supplements and can — and do — take action when necessary to police the marketplace.

Said the NPA, “The Dietary Supplement Health and Education Act of 1994 (DSHEA) gave the U.S. Food and Drug Administration the power to ensure dietary supplements are safe, properly labeled and that the claims they make are substantiated.”

DSHEA maintains the FDA’s authority to safeguard the public against any unsafe product. In fact, a dietary supplement can immediately be removed from the market if the Secretary of Health and Human Services believes that the product poses an imminent risk to public health.

On December 22nd, 2006, the U.S. president signed the Dietary Supplement and Non-Prescription Drug Consumer Protection Act, S. 3546 (“the SAER bill”) into law. With the SAER law now in place, clearer safeguards are provided for products that are already profoundly safe.

In June 2007, the FDA issued the final rule on Good Manufacturing Practices (GMPs), which, according to, is regarded by many as “the most important regulatory development for the dietary supplement industry in over a decade.”

Did you know, however, that the NPA established the first GMP certification program for dietary supplements in 1999 and has provided GMP education to the industry, through seminars and onsite training, to over 500 companies?

FDA and FTC Oversight

In addition to safety protections, the FDA requires post-market notification of structure-function claims and a whole host of record-keeping and reporting requirements. The FTC, meanwhile, spends the majority of its enforcement budget identifying, targeting and prosecuting dietary supplement manufacturers it believes are engaging in deceptive or fraudulent practices that harm, or could harm, consumers.

In an effort to help manufacturers comply with FTC requirements, the Natural Products Foundation also offers a Truth in Advertising program.

Gormley Take-Away: You may rest assured that dietary supplements are well-regulated by both the FDA and the industry, as the examples in this article show. For additional perspective on dietary supplement safety, please visit Neil Levin’s Honest Nutrition blog and a 2007 article of mine in Vitamin Retailer magazine.

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