In the generally staid world of dietary supplements, recent months have brought less-than-welcome excitement. The U.S. Food and Drug Administration is cracking down on adulterated supplements—most visibly in April, slapping a $500,000 fine on Bodybuilding.com CEO Ryan DeLuca for selling sports supplements containing steroids.
The agency also has been busy sending out warning letters to companies that violate good manufacturing practices (GMPs) and rules about labeling and marketing claims. In January, The Dr. Oz Show featured an exposé on conventional weight-loss supplements spiked with the banned drug sibutramine. Then NBC’s Dateline turned its lens on “dry labbing,” a practice in which suspect labs fake results, in some cases, without testing a sample.
When questions arise about supplement quality, shoppers’ faith in the supplements they ingest in pursuit of better health may falter—and retailers are on the front line.
“Retailers are the ultimate gatekeepers for what’s available to consumers,” says Mark Ullman, partner at the New York City–based law firm Ullman, Shapiro and Ullman, which follows FDA actions closely and sends out newsletter updates.
In today’s world of regulatory activity and class action lawsuits, retailers not only have a responsibility to vet the quality of supplements they carry, but increasingly, they may be held liable for selling a suspect product, industry experts say. “It’s important that retailers stay vigilant; it will result in accountability,” says Scott Steinford, president and founder of Spring, Texas-based ZMC-USA, a subsidiary of Chinese ingredient manufacturer ZMC.
What's the retailer's liability?
By and large, retailers work to make sure the products on their shelves are safe and effective because they care about their customers’ health—not because they’re worried about possible liability.
But as litigation increases, store owners can’t afford to ignore the issue.
“A number of retailers, large in particular, are stepping up their internal quality standards programs for good reason: Their good name is on the line should a quality failure occur for a product they sell,” says Loren Israelsen, executive director of the United Natural Products Alliance. “Consumers are looking to retailers as a trusted source—where you purchase is an important consideration, along with what you purchase. Increasingly, the retailer is a strong co-brand to the product brand itself.”
To date, lawsuits have targeted mostly big-box retailers. Some have involved pro athletes claiming they failed a drug test after buying and then using an adulterated supplement. Others have focused on products containing ingredients such as the purported weight-loss aid homeopathic hCG or the performance enhancer DMAA.
But the landscape could soon change to affect smaller, independent retailers. As an example, for class action suits under California’s Proposition 65 substance regulation act, “attorneys are buying products off retail shelves,” Steinford says. “So far they’re not saying where they bought them, but they could and they may.”
It’s important to remember that adulteration isn’t just a concern in problematic categories such as weight-loss, sports and libido supplements. Industry experts such as Frank Jaksch, founder and chief scientific officer of ChromaDex, an Irvine, Calif.-based third-party testing company and proprietary ingredient manufacturer, warn about economically motivated adulteration of ingredients such as bilberry and chondroitin—supplements most natural products stores carry.
4 tips for stocking safe supplements
What steps can retailers take to ensure they’re stocking consistently high-quality, safe products? Store owners and manufacturers who are passionate about this issue offer these tips.
1. Get it in writing.
Although his approach to purchasing was more casual when he and his wife started Cambridge, Mass.-based Cambridge Naturals almost 40 years ago, Michael Kanter says the recent hype about spiked supplements has made him much more cautious. This year, he sent a query letter to all of his vendors in an effort to learn more about their products. “Get your manufacturers to send you proof of testing,” he advises. “Then you have documentation in your records; it puts them on the spot.”
At Boulder, Colo.-based Pharmaca Integrative Pharmacy, current and potential vendors complete a 13-page quality assurance questionnaire that covers everything from contact information to notice of any formula revisions to a history of any FDA warnings or recalls. All new products must qualify, and vendors renew the agreement every three to five years, says Don Summerfield, Pharmaca’s vice president of integrative medicine.
2. Visit the FDA website regularly.
At FDA.gov, you’ll find a public record of all recent FDA actions, including warning letters and product recalls.
“That’s the truth—no marketing spin there,” says Beth Pecenka, director of marketing and strategy at NOW Health Group in Bloomington, Ill. Like other manufacturers, NOW Health Group has had more surprise visits from FDA inspectors than usual: two in the last two years.
Although the unannounced visits can feel unnerving, Pecenka says, enforcing good manufacturing practices is a great thing for the industry. An FDA warning letter involving GMP violations is generally considered more of a concern than one about label claims because it means the company already got a 483 observation about a problem but hasn’t satisfactorily resolved the issue.
If you see a notice about a manufacturer you work with, ask its representatives what the FDA found and what the company is doing to resolve the issue, Pecenka recommends.
3. Meet with vendors in person.
“You learn a lot by talking to people at the companies directly,” Kanter says. Manufacturer store visits can help educate both staff and customers. And making the effort to visit plants is invaluable, especially when it comes to private-label contract manufacturers, he says. To promote transparency, NOW Health Group invites retailers to visit once a year. FoodState, the company behind the MegaFood brand, hosts monthly public tours of its Derry, N.H., facility.
4. Ask about third-party certifications.
With growing consumer concerns about the quality of supplements containing ingredients made in China and other countries, retailers need to do more than just talk with U.S.-based manufacturers; they need to verify the ingredient vetting process, Steinford says. “The retailer has a responsibility to the consumer to make sure that price is not the ultimate factor in determining what goes into the product,” he adds. Certifications by independent entities such as the U.S. Pharmacopeial Convention and NSF also instill confidence.
You can also go one step further and randomly screen products on your shelves. If you sell high-risk supplement categories such as weight loss or libido, it’s a good idea to regularly send samples to a lab, Jaksch says. “Everyone knows there’s a lot of noise about adulteration in these categories, so selling these products is a risk.” The $800 cost of a testing panel for libido supplements, for instance, is a reasonable outlay to ensure your products are safe, he adds.
Why is this important?
Although every business owner wants to make money, retailers who sell dietary supplements assume a unique role that’s fundamentally based on consumer trust.
“They’re not selling cellphones—they’re selling biologically active products to help customers stay healthy,” Ullman says. By helping self-police the industry—and store shelves—instead of waiting for authorities to enforce penalties, retailers can strengthen the industry, Steinford says.
Ultimately, Kanter speaks for counterparts across the country when he explains what motivated him to open a health food store: “You start with a mission of carrying great products—not products that will sell.”