What's in the bottle? It should be an easy question to answer by simply looking at the Supplements Facts box on the label. But it's often not as simple as it seems. Does the product contain what the label says it does? Does it contain marker compounds at the claimed levels? Is there a qualitative difference between two products containing the same ingredients? What does the product contain that isn't listed? For example, has it been tested for pesticide residue, heavy metals, molds and bacteria? Where do the raw ingredients come from, and does that affect quality? Does it contain specialized branded ingredients backed by research, and does this offer a guarantee of quality?
"From the consumer point of view, it's very confusing to see several products that look the same—whether it's garlic or ginseng or something else—and see a price range of four to six times between the least expensive and most expensive brands," says Loren Israelsen, president of LDI Group, a dietary supplements consulting firm based in Salt Lake City.
"The baseline is that the law requires every single product to be accurately labeled," says Michael McGuffin, president of the American Herbal Products Association, based in Silver Spring, Md. "It shouldn't be the retailers' responsibility to fly to the manufacturing facility, whether it's in China or North Carolina, and make sure the herb is the right species."
"Unfortunately, there is cheating going on," Israelsen says. "In the last 12 months, [the Food and Drug Administration] has caught a few dozen cases, especially in the stimulant area, where companies might spike a guarana product with synthetic caffeine, which is cheap. But this is particularly a problem with the Internet or direct market, not so much in the retail market. I think it's fair to say that these are two different worlds."
In the retail channel, the most common question from consumers is pricing: Why is this bottle $5 and this one $20? "It's an easy test of quality," McGuffin says. "There's a pretty good chance that a $20 bottle has higher-quality ingredients than a $5 bottle."
Changes in the global herb market are one reason for the disparity, with many ingredients coming from countries such as China and India that until recently supplied fewer bulk commodity herbs. But experts caution that country of origin is not necessarily a benchmark of quality. "Any country in the world can produce a high-quality and accurately identified plant material, or a poor-quality but accurately identified material, or a fraudulent one," McGuffin says.
"China has been a real challenge, but it's possible to produce very high-quality products there," Israelsen says, "as long as a manufacturer adopts the same standards used by good companies in the United States."
A better measure of quality has to do with the practices used by suppliers of the raw materials that manufacturers use to source their ingredients. "Suppliers range from laptop brokers, who literally buy, sell and trade product from their laptops, to companies with full infrastructure, including facilities, staff, research and precision equipment," Israelsen says. "These companies have quality employees whom they pay well, they purchase expensive raw materials, they invest in quality control and analytical methods, they reinvest in the industry, and they do ongoing research, which is expensive stuff. No wonder there's a dramatic difference in the quality of products."
To recoup these greater expenses, raw materials suppliers often offer manufacturers branded ingredients backed by research. "A lot of the pricing difference has to do with companies not manufacturing extracts to the same quality controls," says Megan Rooney, product manager for Indena, an Italian raw materials and ingredients supplier with U.S. offices in Seattle.
"Another factor for cost is efficacy research to show a product works," Rooney says. "In addition, it costs money to reliably get a standardized extract to test out in every batch. Indena's approach is to brand our more cutting-edge ingredients, so manufacturers can use the name on the bottle."
"Co-branding and secondary branding will certainly be one of the solutions going forward," Israelsen says. "We as an industry need to encourage and support that. A good raw materials supplier can say, 'Look at our standards, see our research, check us out.' There are good brokers out there, but a broker can't do that."
Companies that do in-house research and testing also ensure that the ingredients supplied are free of all contaminants, rather than relying on a broker's word. "We test for residual solvents, pesticides and heavy metals, and have specifications for microbial level, which includes yeast, molds and endotoxin," Rooney says.
Many retailers have very specific criteria for product quality, and rigorously examine product lines before including them in their stores. "Larger retailers, such as Whole Foods, Wild Oats and Costco, have their own internal standards, which are pretty rigorous," Israelsen says. "When a customer goes into a retail store, it's reassuring to know that they have their own standards and require more verification."
Smaller retailers often create their own questionnaires and documents for manufacturers, but without expert guidance it can be difficult to know what questions to ask. "What should a retailer do?" McGuffin asks. "What are the right questions to ask your manufacturers—proper and articulate questions that aren't harassing and don't cause unnecessary busy work?"
One approach is a new document created through a cooperative effort by AHPA, the Consumer Healthcare Products Association, the Natural Products Association and the Council for Responsible Nutrition. This voluntary industrywide protocol, called Standardized Information on Dietary Ingredients, is intended to facilitate the efficient exchange of information between raw materials suppliers and manufacturers. It's designed to reduce confusion caused by the various lengthy questionnaires that manufacturers require from suppliers, but could eventually serve as a template for retailers who request product information from manufacturers.
The Dietary Supplement Health and Education Act requires accurate labeling, while testing and research are addressed in the Good Manufacturing Practices rules for dietary supplements that the FDA recently announced it would publish—nearly 13 years after DSHEA stipulated their creation. However, the individual initiatives of suppliers, trade groups and voluntary labeling efforts currently offer the strongest guarantee of quality. "Critics of DSHEA will say that this is a result of the law itself," Israelsen says, "but it's really a significant failure to regulate the industry. FDA is underfunded, understaffed, and has no mandate or internal will to enforce this law, which it is not fond of."
Though many companies put quality first, the absence of enforceable regulation opens the door for disreputable companies, particularly in the direct marketing category. "It's hard to self-police because you can't see what you're doing; it's like trying to perform eye surgery on yourself," Israelsen says.
"We're pushing for GMPs to be published, and we wish that FDA would put more money into checking supplements—not just for unallowed claims, but to make sure the product is what it says it is," Rooney says. "Besides independent certification labels and ConsumerLab's testing, there's not a lot going on." The result of the current regulatory situation is that, like it or not, retailers remain the gatekeepers of quality.
Though GMPs will soon appear in the Federal Register, it remains to be seen just what the final rule entails, and whether FDA has the will and the funds to enforce the rule once it becomes law.
Mitchell Clute is a Fort Collins, Colo.-based freelance writer.
Natural Foods Merchandiser volume XXVIII/number 7/p.34