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A watched pot may not boil in the kitchen, but new attention from FDA (Rockville, MD) may actually keep the supplement trade percolating this year. After a year of economic difficulties and latent promises of new regulations, the CGMPs were finally instated this June. A sense of relief echoed through industry that, after all of the buildup, official guidelines are now in place.
Much has happened in the past year: a new administration, a new FDA commissioner, and now, new regulatory guidelines to bring FDA at eye-level with the industry.
In light of the lack of self-regulation at the root of a few companies' worst moments this year, the new GMPs now have the capability to provide a cornerstone of legitimacy that the industry so desperately needs. However, the new GMPs are not the be-all and end-all answer for companies that do want to abide by regulatory parameters. The new GMPs are still lacking much. For example, they do not address which specific tests companies must conduct to prove what substances are contained in their products. That's an important oversight, especially because in some tests, some companies may substitute some ingredients to falsely obtain positive results. The rules also set no limits on toxins such as lead; nor do they change the fundamental way these products are sold to the public.
"It leaves the level of quality up to the manufacturer," said Tod Cooperman, MD, president of ConsumerLab.com.
As a result, this vacancy leaves a window of opportunity for industry to act proportionately by stepping up its own self-regulation. FDA spokeswoman Susan Cruzan said the new GMPs contain what is "needed to ensure quality." Products that contain contaminants or whose labels do not honestly describe their contents are considered adulterated and are subject to further action by the agency.
But she conceded that the agency is spread thin. "Because FDA has limited resources to analyze the composition of food products, including dietary supplements, it focuses these resources first on public health emergencies and products that may have caused injury or illness," she says.
A Quality Concern
In a survey conducted by Nutritional Outlook earlier this year, the majority of manufacturers cited quality as a principal issue when buying ingredients. This is as important as ever, considering some of the news that came out this year. In April, ConsumerLab.com found lead in at least one brand each of the zinc, black cohosh, and ginkgo products that it tested. Because of this, the testing company wants to instate a national lead ingestion limit of 0.5 µg per day-a level that, in at least California, already requires a warning label on a dietary supplement or medication.
A glaring issue regarding lead consumption concerns ayurvedic products. A Journal of the American Medical Association report last year concluded that taken at maximum dosage, one-fifth of the 200 ayurvedic products tested in the study would exceed lead limits set by California and other states, but not limits set by the World Health Organization (WHO; Geneva). The difference between global and American standards may account for the presence of lead in some products produced overseas. This is because levels acceptable to WHO may be up to 500 times higher than levels acceptable to some U.S. states. Yet even small amounts of lead in the bloodstream have the potential to cause kidney failure, high blood pressure, and seizure, according to the report.
Some place the blame for high lead levels on negligent companies. "We're talking about a medical system that has existed for centuries," says California Association of Ayurvedic Medicine (Redondo Beach, CA) member Narender Pati, RPh, a pharmacist who earned his degree in ayurvedic science. "The question here is not about ayurveda, but rather about a small number of unregulated ayurvedic products by irresponsible companies. They have somehow been able to bypass all world and state regulations."
Much of this irresponsibility may come from simple inattention. Metals naturally accumulate in certain herbs and come from the soil they are grown in. Also, many supplement ingredients come from Europe, India, and China. "We don't know how much of the ingredients are imported-whether they're coming from across town or across the world," says Steve Mister, president of the Council for Responsible Nutrition (CRN; Washington, DC).
For these and other reasons, manufacturers may not catch the presence of lead-or other types of product adulteration, said Jana Hildreth of the Analytical Research Collective, a group of scientists advocating better supplement testing.
"Companies started going to China and demanding lower prices," she said. Some suppliers sometimes may have spiked products with cheaper ingredients. An example: a buckwheat derivative, rutin, in place of pricier ginkgo.
To confirm this claim, last November ConsumerLab.com found that four out of seven supplements contained less ginkgo than claimed on their labels, and one failed to break apart properly to release its ingredients. It's been a continuing trend. In similar ginkgo tests by ConsumerLab.com in 2005, six out of 13 supplements contained less ginkgo than claimed, as did seven out of nine supplements in a 2003 test.
"It is now believed that ginkgo is among the most adulterated herbs," the company reported.
In another ConsumerLab.com report, six out of nine chondroitin supplements failed testing in April 2007. One had only 8% of what it claimed to contain, and one "max-imum strength" product had none.
And it's not only low ingredient levels that are problematic. In some cases, ingredient levels can be too high. In one case, nearly 200 people were sickened by supplements containing up to 200 times the amount of selenium stated on the label, according to ConsumerLab.com.
Industry Steps Up
The industry has stepped up self-policing. CRN has supported the Council of Better Business Bureaus (BBB; Arlington, VA) by helping the council hire a lawyer to investigate some supplement sellers' imprecise claims.
"There were cancer cures and 'blast off 29 pounds in 39 days'-really the Wild West of advertising. It was totally out of control," says the BBB's advertising division director Andrea Levine.
The BBB council targets the worst claims in popular categories, such as diet and joint problems.
Levine says that while BBB can't cover all products on the market, it wants to send a broad signal about what kinds of claims are over the line for each type of product.
Suppliers agree that producing quality ingredients is a vital part of responsibility. "The new GMP rulings are definitely one of the ways to prevent concerns such as low-quality products. Companies that continue to promote products without adequate science and understanding of medicinal plants are going to be seriously compromised," says Antoine Dauby, marketing manager of Naturex (South Hackensack, NJ). "As a member of the industry, we have a responsibility towards the health and the well-being of end consumers."
The Economy's Surprising Role for the Future
Deanne Dolnick, sales manager of Next Pharmaceuticals (Salinas, CA), says that more product testing and positive results is what industry needs to combat negative news reports. "When our industry does not strike back with positive press, how can negative reports not affect consumers' views?"
However, a consequence of the economy is that companies can't afford to do as many clinical trials as they should, says Dolnick. "And that's really what we need right now. We need information disseminated to the public that will enforce how beneficial many of our products are to the general health of the population," she notes.
In some ways, the economy may be helping. Perhaps because of the economy, concern for disease prevention has been magnified. "Because people don't want to get sick, vitamins specific to certain groups like men, women, and children are poised for growth, along with heart health formulations and omega-3s," says Kerry Watson, natural product specialist for SPINS, an agency that provides natural products sales data to the industry.
The industry is looking toward the horizon at a year of accountability and dependability. "Science," "clean-label," and "origin" will be key words, says Dauby. As more and more people become aware of environmental issues and safety concerns, he says, it is no surprise that the seismic shift toward natural ingredients will continue. More botanical extracts are coming to market every day, and because of market growth, it is no longer enough to merely introduce a natural ingredient and believe that a natural statement alone will make it distinctive. "People are looking for more in terms of benefits," he says. "It means that product development has to meet performance expectations of consumers." He points to geographical niches like the Amazon or North Africa for a wealth of new ingredient possibilities such as cat's claw, which is a botan- ical that has been used since ancient times by the indigenous people of the Amazon rainforest for the prevention and cure of many diseases.
Convenience is another dependable trend, Watson notes, pointing to the relative ease of premixes and powdered supplements. In the area of superfruits, Watson sees many new product launches ahead, especially those featuring acai. As far as its rise to fame, "It will be interesting to see whether this ingredient has had its day or if it still has legs," she says.
Whatever the upcoming year will bring, one thing is for certain: the economy has provided an unexpected boon for the industry. "We are still seeing small growth over last year," Watson says. "And small growth in this economy is huge."