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The Retailer As Gatekeeper: Revisited

Celadrin

When Vitamin Retailer explored this topic in 2011, the news of the GAO’s surprising undercover secret shopper report was still stinging. Here, the conversation continues with leaders in the natural product industry, who review what’s happened since the report, including a discussion on how retailers can be confident they are DSHEA compliant while providing top-quality products to their customers.

In 2010, the Government Accountability Office’s (GAO) secret shopper report found that in a number of retail establishments visited, the salesperson made inappropriate or illegal claims about dietary supplements, which is in violation of the Dietary Supplement Health and Education Act (DSHEA). The investigation results drew response from the Natural Products Association (NPA), which said misleading customers is “not acceptable.” Since the report, the natural products industry has made changes, but questions remain on whether it has been enough.

“The natural product industry, both retailers and suppliers, take DSHEA and all its provisions very seriously. The secret shopper report served as a reminder of these provisions; specifically that dietary supplements are not intended to cure, treat or mitigate diseases, and the industry cannot mislead consumers about the supplement’s purpose,” said John Shaw, NPA CEO and executive director. “Shortly after the release of this report, NPA released its Retailer Toolkit, which spells out what retailers can and cannot say about the products they are selling. Additionally, the Natural Products Foundation has been active over the past three years with the Truth in Advertising program, educating manufacturers on claims that are above and beyond what is truthful.”

Ron Antriasian, vice president of sales and business development with Florida-based Life Extension, said natural product retailers are more likely to have valid reference materials in their stores, to direct customers to credible journals, which contain fully referenced articles, and/or to ensure that a supplement regimen is tailored to meet a customer’s specific needs by asking the right questions and by reminding the customer to work closely with a health care practitioner.

Despite these advancements, Carol Nicholson, RN, president and founder of International Marketing Company (IMC) in California, is still skeptical. “I’m not aware of any major industry changes,” she said. “NPA does have a 15-page booklet for retailers, but I think a lot more could be done.

“I think it is all about training,” she added. “Bastyr University had a retailer training program that IMC helped market in the early 90s. I would encourage the NPA to create an Online Retailer Training that all store owners and management can access. This will be a key element in helping retailers and their employees.”

Staying Compliant While Discussing Products

Once a product is in the retail environment for purchase, whether a supplement claim is made hinges on a retailer’s comments when talking with shoppers. The verbal interface, which occurs at the point of sale, is an important exchange because it helps guide consumers to the supplement products that are well suited for their individual needs.

“Retailers and their employees need to be trained to understand DSHEA regulations,” said Gene Bruno, MS, MHS, formulator with New York-based Twinlab Corporation. “Arguably, the two biggest DSHEA regulations are related to structure/function claims and thirdparty literature. Product discussions with customers should always take place in terms of structure/function claims (i.e., the role that a dietary ingredient has in the structure or function of the human body), not in terms of disease claims. Failing to do so is more likely to increase your risk of regulatory problems. For example, assuming that a joint support product contains clinically relevant amounts of a validated nutraceutical, an appropriate structure/function claim might be: ‘Product X helps support joint comfort and flexibility.’ An inappropriate disease claim would be: “Product X helps reduce your arthritis pain.”

Life Extension’s Antriasian agreed, reiterating that retailers can be sure they are DSHEA compliant when discussing products with their customers by structuring their communication— whether through print, online or customer- facing employees—so it includes, but is not limited to:

• Avoiding disease claims (i.e., that any natural product or supplement “cures” or “prevents” a disease or condition);

• Focusing on structure/function claims (i.e., that said products “support” or “promote” existing bodily functions); and

• Ensuring that supplements are not marketed as alternatives to approved pharmaceuticals.

IMC’s Nicholson circled back to another key DSHEA regulation, which is third-party information. She noted that retailers should make sure they also have a resource guide covering a community’s integrative and complementary health care providers. “If a customer has serious health issues, you want to refer them to that guide and to reputable online environments that cover their health challenges,” she said. “Many stores are hiring naturopaths to give health suggestions to their customers. While this has to be evaluated on a state-by-state basis for licensing issues, it can be really helpful.

“Also, develop your book section—it needs to be 100 feet from your supplement product shelves. (Stores that are smaller need to separate their books and newsletters from the supplement aisle),” Nicholson continued. “When customers have condition-specific questions, you can refer them to these books. For example, Nutribooks and Square One Publishing have health books on many supplements.”

Antonio Gallegos, attorney with Greenberg Traurig, LLP in Colorado, said, ultimately, retailers could stay compliant by providing clear information and education to their staff about how to simply and effectively utilize DSHEA in the retail environment. “It is important for retailers to take responsibility for their employees knowing how to work and speak within the boundaries of DSHEA.”

There are any number of resources out there for reference, but NPA, as the trade association for industry retailers, specifically has its Retailer Staff Education Toolkit, which can be found on the Association’s website. “This toolkit includes the Dietary Supplement Claims Handbook, a tri-fold brochure for employees to keep; a pocket-sized card for employees to keep on hand; and a store shelf-talker to explain what type of information customers can expect to receive from store employees,” said Shaw. “It’s a comprehensive set of materials to ensure stores are operating within the law.”

Trinity Ava, herbalist and founder of VeRdant consulting based in California, said that there is more information you can say legally with DSHEA if you know the rules. “In an effort to support more retailers, I have begun offering webinar trainings called ‘Understanding & Utilizing the Wisdom of DSHEA with Customers in the Retail World: Providing customer service with heart, mind and legal awareness.’”

Discussing Label Claims

To stay DSHEA compliant, first and foremost, supplement buyers should not put products on the shelf that make curative health claims. “We all know better, so we should do better,” said Nicholson. “If it is a great product and you really want it in your store, ask the manufacturer in writing to do new packaging. IMC specializes in this. That also goes for literature from the company and their website; it all has to be compliant.”

The big challenge is that compliant claims can be vague, she noted. “Let’s say you have a vitamin D3 supplement that is marketed primarily for bone health, but you’ve had a few customers coming in talking about their seasonal affective disorder (SAD). You’ve read the studies about D3 and its effects on SAD. How do you make the connection without talking about a disease state? It’s not that hard. Remind them you’re not a doctor, but you’ve seen studies on how D3 is not only good for bone health, it also helps maintain a healthy mood, especially during normal seasonal reductions in sun exposure.”

The greater challenges are in areas such as inflammation. “In the past we’ve been able to talk about ‘healthy inflammation.’ This opened dialogue on everything from joint health to heart health to balanced immune system activities,” said Nicholson. “Today, the FDA is frowning on all uses of ‘inflammation’ terminology. When customers come in with inflammation-related discussions, your third-party book section becomes an absolute necessity.”

Research & News

Retailers can discuss studies, news, third-party literature, websites, etc., with customers provided that they do not mention or connect the information to any specific product to treat a disease claim. “Knowledge is power and retailers can share this freely provided they do not mention treatment for a disease claim,” said Ava.

“They would also be smart to encourage their customers to talk to their health care providers, to refer their customers to valid reference materials, and to encourage their customers to do their own research by utilizing credible resources which contains fully referenced articles,” added Life Extension’s Antriasian.

NPA can serve as a good resource when retailers are looking for responses to certain studies, positive or negative, added Shaw. “As a third-party, NPA can provide its interpretation of the results that are discussed in a particular study. Additionally, if retailers are looking to promote the use of products based on favorable studies, they need to provide the full article to customers and make sure they are presenting it in a fair and well-balanced manner.”

Sharing an Efficacy Study

Generally, retailers should avoid discussing studies that focus on the prevention or cure of diseases. However, there are many studies that support the effective use of dietary supplements to support the diet and contribute to maintaining good health.

Shaw noted that, under DSHEA, retailers are allowed to display thirdparty literature, such as publications, articles, chapters in books and scientific literature, to be used in connection with the sale of dietary supplements to consumers, provided that such information:

• Is not false or misleading;

• Does not promote a particular manufacturer or brand of dietary supplement;

• Presents a balanced view of the available scientific information;

• Is displayed in a store location physically separate from the supplements; and

• Does not have appended to it any information by sticker or other method.

The literature must be reprinted in its entirety, unless it is an official abstract of a peer-reviewed scientific publication. DSHEA also preserves the right of the retailers to sell books and other publications as part of their business in the book section of their store.

“It’s okay to remind customers that you are not a physician,” said Nicholson. “All you can do is pass along compliant information, and refer them to local health care providers and reference materials. Customers understand this.”

Selecting Products

Retailers have to do their due diligence, said Bob Green, president of New Jersey-based Nutratech, Inc., distributor of weight-loss and sports nutrition ingredient Advantra Z bitter orange extract. “Consumers seek out specialty retailers to find products—and knowledge about those products—that they can’t find in the mass market. They assume these retailers have vetted the dietary supplements they carry, as well as the ingredients in them. So it’s even more important for a specialty retailer to responsibly carry DSHEA-compliant supplements and to train its staff on the key selling features of those products. That way, they are capable of educating and guiding consumers to supplements that will help meet their individual nutritional requirements or health concerns.”

“Retailers are in a position to demand only top-quality products, and require that the firm has a quality-control system in place to determine the product actually contains what is stated on the label and is free of contaminants,” said NPA’s Shaw. “GMPs (good manufacturing practices) are designed to ensure that dietary supplements meet their label claim and other quality specifications and are free of contaminants,” he said, adding that, therefore, retailers want assurance that their manufacturers and distributors understand GMP requirements and that their supplements were produced in compliant facilities.

“Retailers should ask about GMP compliance and/or third-party certification,” Shaw continued. “Ask if they manufacturer the products themselves or use contract manufacturers to make their product. Ask what kind of verification testing they do to ensure that finished products meet their label claims and are free of contaminants such as heavy metals, pesticides and adulterants. Look for expiration dates or ‘best if used by’ dates and confirm that these are supported by stability data.”

In addition, Shaw said to beware of companies that claim they or their products are FDA approved—FDA does not certify or approve dietary supplement companies or products. Examine product labels to be sure at a minimum they include the company name and address, a phone number for reporting adverse events, the FDA disclaimer and no disease claims. He also suggested retailers become familiar with the FDA website (www.fda.gov) to research and monitor product recalls, warning letters and consumer alerts.

Life Extension’s Antriasian stressed that it’s important to order from a trusted manufacturer, one that has longevity in the industry and a reputation for quality. “Ask if your manufacturer utilizes third-party testing and if they utilize dosages established with the explicit goal of achieving clinical efficacy. Make sure they have a thorough QA/QC (quality assurance/quality control) process, which includes cGMPcompliant manufacturing facilities. If a promising product is presented, ask to see the published studies and the scientific references behind it.”

Further, Twinlab’s Bruno suggested retailers ask if product formulations include clinically relevant amounts of key nutraceuticals upon which product claims are based. “If research shows that 500 mg of nutraceutical X is required for efficacy, but the product only provides 100 mg, it’s not likely to yield expected results.”

“Manufacturers should also advertise their associations with beneficial trade organizations such as the American Herbal Products Association (AHPA), as well as certifications like organic, kosher or proof they utilize fairly traded ingredients,” said Ava. “In my opinion a manufacturer should want you to know as much about their product transparency as possible. A manufacturer should want to share with consumers and retailers about the many safety steps they adhere to provide safe and effective products.”

Weight-Loss Caution

In early January, the Federal Trade Commission (FTC) announced a law enforcement initiative stopping national marketers that used deceptive advertising claims to peddle fad weight-loss products, from food additives and skin creams to dietary supplements. It has cast a spotlight on the category, but it’s something that IMC’s Nicholson expressed the FTC is right to be scrutinizing.

“Most doctors say to increase your exercise, eat less carbs and keep a food diary. (I would add, go to a great Integrative MD if those simple steps aren’t working.) As for weight management ingredients, what you really want to see are gold standard human clinical trials with more than 100 patients,” she said. “Look at the products you carry— there should be contemporary scientific data on historic uses, such as traditional Chinese medicine (TCM) ingredients. There are many products with rich clinical trial data that should be encouraged, such as L-carnitine. There’s growing scientific support for using probiotics as a foundation for weight management, too. So, recommend well-supported products, but always alongside consulting a physician and developing a plan for healthy diet and exercise. No supplement will let you bypass those choices.”

“The information FTC released is, as they describe it, focused on a ‘gut check’ test. That is, if the information appears too good to be true, it probably is,” added Shaw. “With weight loss specifically, products that guarantee weight loss without changing diet or exercise habits are probably misleading; the same goes for products that give a short timeline for results are likely too good to be true. FTC’s guidance is specified for media to affect what products they promote, but it’s a good reminder for retailers as well when they’re deciding which products to stock.”

As the distributor of a weight-loss ingredient, Advantra Z, Nutratech’s Green stressed that specialty retailers— health food stores in particular— must recognize they are the product and information gatekeeper for their customers.

“It doesn’t matter what outlandish claims fad weight-loss products make in their advertising,” he said. “It’s up to the retailer to educate customers and explain when claims are overblown. Fad weight-loss supplements rarely have substantive research to support their structure/function claims, and because of that, retailers should think twice about populating their limited shelf space with them.”

Green noted that consumers frequent health food stores seeking product information and guidance, otherwise, they’d just go to a mass-market outlet. Therefore, specialty retailers have a particular responsibility to carry legitimate products that are going to work and address their customers’ specific needs.

“It seems unconscionable that a health food store would want to knowingly carry questionable products supported by hyperbole instead of science, especially ones that are also direct marketed with unfounded weight-loss claims,” he said. “Yet some retailers actually let these products on their shelves! It’s the job of specialty retailers to properly vet the products they carry (as well as the ingredients they contain) to ensure that their customers are provided a natural solution that is safe and efficacious. A happy customer is a repeat customer and establishing good customer relationships, which results in repeat business is the name of the game in specialty retailing.”

In conclusion, Nicholson said the GAO’s mystery shopper report was a good wake-up call for the industry. “I love supplements—I spend my entire day working on the marketing of supplements and the legalities around them. I believe they are life-saving and life-affirming, and we all need to play by the rules. If you have a great literature and book area, and a community resource guide available, then you can do a great job and truly help your customers.”

The basic takeaway, according to attorney Gallegos: “Retailers should obtain guidance from legal and regulatory professionals. Trade associations for the supplement industry can be a helpful resource for finding someone experienced with DSHEA and FDA regulations.”