January, 2007
Shaping Up the Dietary Supplement Industry
By Sharon Palmer, RD
Today’s Dietitian
Vol. 9 No. 1 P. 34
With public safety at stake, some organizations are developing initiatives to better protect consumers from false claims and potentially dangerous products.
The dietary supplement industry seems to be a magnet for controversy. It’s not uncommon to find your e-mail inbox flooded with spam on supplements claiming to enlarge choice body parts or spy best-selling diet books peddling an array of dietary supplements aimed at weight loss, antiaging, and beauty. What’s a soul to do but cave in and pop a few pills? And this is just what people are doing. The Office of Dietary Supplements reports that in 2004, consumers spent $20.3 billion on dietary supplements.
Daniel Fabricant, PhD, vice president of scientific affairs at the Natural Products Association, says in defense of dietary supplements, “A smart buyer doesn’t confuse the e-mail spammers making egregious claims with the legitimate dietary supplement industry [any] more than they would confuse the spammers claiming to give away cars with the legitimate automotive industry.”
Sure, smart consumers could simply install a better spam protector to fend off spurious supplement e-mails or ignore ads promoting dubious products, but there will be a certain number of people suckered into wasting their cash on products with little scientific evidence to support them. And of greater concern is the potential for people to be harmed due to fraudulent supplements. When it comes to life-threatening diseases such as cancer, even one consumer who falls prey to a supplement suggesting that it cures cancer in lieu of traditional treatments such as chemotherapy and radiation is too many.
In a study published in Family Medicine in 2002, researchers from the Scripps Center for Integrative Medicine in La Jolla, Calif., conducted Internet searches using the linked terms herb and cancer, resulting in matches for each of the six primary search engines of between 11,730 and 58,605. Further cross matching with the three master search engines revealed that prevention, treatment, and cure were discussed at rates of 92%, 89%, and 58%, respectively. Researchers concluded that although the Dietary Supplement Health and Education Act of 1994 (DSHEA) was enacted to decrease unlawful claims of disease prevention, treatment, and cure, such claims on commercial Internet sites are prevalent.1
“The Internet has had a mixed effect on the supplement industry. It has allowed a lot of bad and misleading products to be promoted very effectively through spam e-mails or professional-looking Web sites. People tend to believe what they see and are trying products that don’t have much evidence behind them,” says Tod Cooperman, MD, president of ConsumerLab.com, a Web site that provides independent testing and reviews of dietary supplements.
The Upside of the Supplement Biz
In the midst of today’s concern over questionable dietary supplements comes a wave of health professionals speaking out on behalf of supplements, reminding us that not all are created equally. Complementary nutrition is growing, with a number of studies being funded and published that address efficacy of various herbs and supplements.
Take omega-3 fatty acid supplements. Research has supported the heart-healthy benefits of omega-3 fatty acids in supplemental form, suggesting that it may not be possible to get adequate amounts of the omega-3 fatty acids docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA) necessary to effect health change in those with coronary heart disease through diet alone. In addition, some supplement manufacturers remove heavy metals and other contaminants from fish oil, which increases purity, potency, and safety of the product compared with dietary sources of DHA and EPA.2 Even heart health guru Dean Ornish, MD, recommends omega-3 fatty acid supplements in his Lifestyle Program.
And let’s not forget that good, old-fashioned multivitamin and mineral preparations fall under the dietary supplement category. What dietitian hasn’t recommended a standard multivitamin and mineral supplement for a patient with less than desirable nutrient intake? “We don’t have a problem with vitamins and minerals in general, but they are lumped in with the herbal and other questionable products used in the United States,” says Ilene Ringel Heller, senior staff attorney at the Center for Science in the Public Interest (CSPI).
The National Center for Complementary and Alternative Medicine (NCCAM) is busy funding studies on a number of supplements such as echinacea and glucosamine/chondroitin. The NCCAM’s position is that there is scientific evidence for the effectiveness of some complementary and alternative medicine treatments, but for most, there are key questions yet to be answered through well-designed scientific studies, such as whether they are safe and work for the diseases or conditions for which they are used.
Consumer Perceptions Surrounding Supplements
Consumer attitudes are all over the place when it comes to dietary supplements, but one thing is for sure: people are using them. Fabricant reports that more than 70% of American consumers use dietary supplements and that these consumers are typically well-educated, both in general and about the products they’re buying.
Douglas S. Kalman, PhD candidate, MS, RD, FACN, director of nutrition and applied clinical research at Miami Research Associates and chair of the Nutrition in Complementary Care Dietetic Practice Group (NCC-DPG), says, “Customers believe in the industry. A recent study found that 34% of consumers looking to lose weight first turn to a dietary supplement as their adjunct in the battle against obesity.”
But consumers are also confused. According to a recent national survey, American adults believe weight-loss supplements are safer and more effective than they really are. More than 60% of 1,444 telephone respondents in the survey, all of whom had made significant efforts to lose weight, said weight-loss supplements have been tested and proven safe and effective. More than one half stated that these supplements are approved by the FDA.3
“Things are really out of control,” says Heller, who reports that some customers don’t notice the FDA disclaimer required on dietary supplements (stating that the FDA has not reviewed the statements made) and interpret it as an FDA approval for the product. Other consumers band together in groups such as Save Our Supplements to rail against further regulation of the dietary supplement industry.
“Over the last five years, it seems that consumers have become more interested in information about dietary supplements as opposed to taking promotional material at face value. It seems that more people are realizing that this industry is not well-regulated by the government, although many still think supplements are as well-regulated as prescription medications and over-the-counter medicines,” says Cooperman.
The Regulatory Backdrop for Dietary Supplements
So how did an environment evolve that allowed dubious supplements such as breast enhancers to flourish? Flash back to the enactment of DSHEA in 1994. Dietary supplements were defined as products intended to supplement the diet; containing one or more dietary ingredients (including vitamins, minerals, herbs or other botanicals, amino acids, and other substances) or their constituents; intended to be taken by mouth as a pill, capsule, tablet, or liquid; and labeled on the front panel as being a dietary supplement.4
Dietary supplements are regulated by the FDA but differently than other foods and drugs. A dietary supplement cannot claim on its label that it will diagnose, cure, mitigate, treat, or prevent a disease. The label of a dietary supplement may contain one of three types of claims: a health claim, nutrient content claim, or structure/function claim. Health claims describe a relationship between a food, food component, or dietary supplement ingredient and reducing risk of a disease or health-related condition. Nutrient content claims talk about the relative amount of a nutrient or dietary substance in a product. And structure/function claims are statements about how a product may affect the organs or systems of the body without mentioning a specific disease. The latter claims do not require FDA approval, but the manufacturer must provide the FDA with the text of the claim within 30 days of putting the product on the market. Product labels containing such claims must also include a disclaimer that reads, “This statement has not been evaluated by the FDA. This product is not intended to diagnose, treat, cure, or prevent any disease.” The label of a dietary supplement product is required to be truthful and not misleading. If the label does not meet this requirement, the FDA may remove the product from the marketplace or take other action.4
Supplement ingredients sold in the United States before October 15, 1994, are not required to be reviewed by the FDA for their safety before they are marketed because they are presumed to be safe based on their history of use. For a new dietary ingredient (not sold as a dietary supplement before 1994), the manufacturer must notify the FDA of its intent to market a dietary supplement containing the new dietary ingredient and provide reasonable evidence for safe human use of the product.4
Dietary supplement makers do not have to provide the FDA with evidence that dietary supplements are effective or safe. Once a dietary supplement is marketed, the FDA has to prove that the product is not safe to restrict its use or remove it from the market. The quality control of dietary supplements depends on the manufacturer, supplier, and production process.4
A Whole Batch of Problems
“There are lots of problems with dietary supplements. There are no regulations that dictate appropriate serving recommendations. There is no organized collection of adverse events so that safety problems can be spotted early,” says Cooperman. “The area that we focus most on is product quality. We are seeing one fourth of the products that we select for testing to have a quality problem. We find products with none or little of their claimed ingredients, products contaminated with lead or pesticides, [and] tablets that won’t break apart to release their ingredients. Many products don’t even specify a dose that is known to work.” Cooperman gives an example of zinc lozenges for colds. Three fourths of the products that ConsumerLab.com tested did not have or suggest the amount of zinc that has been shown to be effective.
So what happens to all the products that don’t contain what they are supposed to contain? Cooperman reports, “It is very rare that a manufacturer recalls a supplement, even after a report comes out on a product. The retailer is not required to recall the supplement. Only when people are really being hurt does [the] FDA take serious action against a manufacturer.”
Heller agrees: “[The] FDA does not have recall authority over supplements. If there are fly-by-night supplements being made, they are not going to get off the market or off of shelves.” Heller also believes the structure/function claims allowed on dietary supplements are close to disease claims and that many dietary ingredients in supplements on the market are grandfathered in, so there’s a presumption of safety rather than the actual determination of safety.
Protecting Consumers
A movement is growing aimed at better protecting consumers. One leader of the pack is Sen Richard J. Durbin (D-Ill.), who introduced legislation to require dietary supplement manufacturers to ensure their products are safe before they are sold.
“Sen Durbin has orchestrated the adverse effects reporting legislature,” says Heller, who reports that this legislature would obligate of dietary supplement manufacturers to report adverse effects. “This goes back to the ephedra case in which there were about 16,000 adverse effects, but the manufacturers had no obligation to turn them over to [the] FDA. One percent of all adverse events are reported to [the] FDA under the current voluntary system,” adds Heller. Dietary supplements containing ephedra have been banned in the United States since April 2004.
Edward Blonz, PhD, FACN, FNAASO, a newspaper nutrition columnist and author, has also taken up the cause. Blonz reports, “I now have three cases with the Federal Trade Commission [FTC], and I work for a group of 11 DAs [district attorneys] in California. All these efforts involve issues of questionable advertising claims being made for dietary supplements.” Blonz also teaches a class at the University of California, Berkeley titled “Dietary Supplements: What Every Health Professional Needs to Know” and is seeking funding for a stand-alone nonprofit organization that will aim to analyze dietary supplement advertising claims to provide information about products and their associated claims to consumers.
CSPI has worked extensively on making dietary supplements safe and honestly labeled. Quackwatch, Inc. is a nonprofit corporation whose purpose is to combat health-related frauds, myths, fads, fallacies, and misconduct that often involve dietary supplements. Founded by Stephen Barrett, MD, in 1996, Quackwatch, Inc. works to investigate questionable claims, advise quackery victims, report illegal marketing, and attack misleading advertising on the Internet. ConsumerLab.com includes review articles on various supplements to help educate consumers and healthcare professionals. Many NCC-DPG members work on forwarding progress in manufacturing practices, clinical research, and open communication with the FTC, the FDA, and other agencies. Numerous credible Web sites (see sidebar) offer scientific information on herbs and supplements.
Tired of suffering a tarnished reputation at the hands of shady supplement makers, those in the dietary supplement industry are also banding together to clean up the industry. “The supplement industry has had bad press in recent years. Some of the industry supports adverse event reporting as a way of repairing that image,” says Heller. The Natural Products Association, along with several other dietary supplement organizations and consumer groups, is supporting legislation in both the House and Senate that would require the reporting of serious adverse experiences for dietary supplements and over-the-counter drugs. (The Senate recently passed this legislation.) Kalman, who performs clinical trails for the food and supplement industry, also finds more and more companies working on independent research for supplements.
The American Herbal Products Association, the Consumer Healthcare Products Association, the Council for Responsible Nutrition, and the Natural Products Association recently announced a voluntary industrywide protocol, Standardized Information of Dietary Ingredients, to facilitate the exchange of information between ingredient suppliers and finished product manufacturers to help identify and qualify supplement ingredients from trustworthy sources.
Good Manufacturing Practices
One action eagerly awaited is Good Manufacturing Practices (GMP) for supplements. The FDA is authorized to create GMP regulations describing conditions under which dietary supplements must be prepared, packed, and stored. The FDA published a proposed rule in March 2003, but until this proposed rule is finalized, dietary supplements must comply with food GMPs that are primarily concerned with safety and sanitation rather than quality.
“It’s been 12 years since they have been promised, and there are still no established GMPs for supplements. There is a lot of talk about them coming out this year, but they say that every year. If GMPs are approved, manufacturers will be required to make the products the same way from lot to lot. This would be a step in the right direction,” says Cooperman. “To be even more meaningful, GMPs would include standards around what is supposed to be in the product. For example, what levels of specific plant chemicals should be in a product claiming to be gingko, garlic, or ginseng.”
Fabricant reports that rather than waiting for the federal GMPs to be issued, his association developed its own GMP certification program in 1999. The Natural Products Association has certified nearly 60 companies and provided education for representatives from more than 350 dietary supplement companies. Their standard is used by other organizations as the basis of their dietary supplement GMP program. “GMPs mean understanding, analyzing, controlling, and documenting the manufacturing process. It is a third party audit system,” says Fabricant.
Dietary Supplement Certification
Voluntary certification can offer supplement consumers some quality assurance. ConsumerLab.com, which offers a voluntary certification program, is finding more and more manufacturers interested in certification. They allow manufacturers and distributors to use specific “CL Seals” to identify products that have met ConsumerLab.com standards based on its product reviews.
NSF International, a public health and safety company, also developed an independent product evaluation program to address dietary supplements. Their voluntary testing and certification program verifies the identity and quantity of dietary ingredients listed on the product label; ensures the product does not contain undeclared ingredients or unacceptable levels of contaminants; and demonstrates conformance to currently recommended industry GMPs for dietary supplements.
Enforcement Action
“There is a little bit of action, a joint program between [the] FTC and FDA, to go after products on the Web,” says Heller. “[The] FDA is increasing enforcement on dietary supplements, but it’s not at the level it should be.”
The FTC and FDA work together against fighting dietary supplement fraud. The FDA has primary responsibility for claims on product labeling and the FTC has primary authority over advertising claims. The FDA can identify fraudulent products through market surveys, inspections, Internet searches, adverse event reports, consumer complaints, informants, and referrals from other government agencies. The highest priority for the FDA are products that pose direct health hazards to consumers. When a problem arises with a supplement, the FDA can act by working with the product’s marketer to correct the problem voluntarily. If that doesn’t work, the FDA may bring a lawsuit to seize the product and enjoin the firm marketing it. The FDA can also seek criminal penalties against parties breaking the law.
Although it may seem like a drop in the bucket, many examples do exist in which the FDA and FTC went after supplement makers that broke the law. Recently, it made news when the FDA and FTC sent warning letters to dozens of U.S.- and foreign-owned Web sites selling or advertising dietary supplements that claimed to cure, treat, or prevent diabetes. These were discovered through an Internet sweep for fraudulent sites and products.
Finding a Safe Place for Complementary Nutrition
While fraudulent dietary supplements may sully the industry’s reputation, it’s important for dietitians to be objective and equip themselves with knowledge to better guide their patients. After all, many of your patients are probably taking supplements, whether or not they tell you. Numerous reputable sources of information on dietary supplements are available to guide your patients to making safe choices.
“Our goal is to educate dietitians about complementary nutrition. Some of our members have written articles in USA Today. There is good, solid information out there,” says Kalman. “Unfortunately, a lot of dietitians’ quest for information is limited to what they are exposed to. They are unaware of academic, NIH [National Institutes of Health]-approved nutrition education on complementary nutrition.”
In today’s world of healthcare, there is room for both traditional and alternative therapies. For cancer patients visiting the Duke Center for Integrative Medicine in North Carolina, the health team may recommend specific vitamins, Chinese herbs, and acupuncture in addition to chemotherapy. The healthcare team takes into consideration the whole person, including support systems, spiritual practices, and stress reduction in an effort to help patients better tolerate chemotherapy.
Integrating complementary and alternative therapies seems to be the wave of the future. Perhaps dietitians can help their patients wade through the sea of supplements to find the true treasures.
— Sharon Palmer, RD, is a contributing editor at Today’s Dietitian and a freelance food and nutrition writer in southern California.
References
1. Bonakdar RA. Herbal cancer cures on the Web: Noncompliance with The Dietary Supplement Health and Education Act. Fam Med. 2002;34(7):522-527.
2. Kris-Etherton PM, Harris WS, Appel W, et al. AHA Scientific Statement: Fish Consumption, Fish Oil, Omega-3 Fatty Acids, and Cardiovascular Disease. Circulation. 2002;106:2747.
3. Americans Fall Prey to Weight-Loss Supplement ‘Hype.’ HealthDay. October 27, 2006. Available at: http://www.nlm.nih.gov/medlineplus/news/fullstory_40638.html
4. Dietary Supplement Health and Education Act of 1994. FDA, Center for Food Safety and Applied Nutrition, December 1, 1995. Available at: http://www.fda.gov/opacom/laws/dshea.html#sec3
Safe and Sound Dietary Supplement Resource Guide
American Dietetic Association
American Pharmacists Association
Center for Science in the Public Interest
Medline Plus, Dietary Supplements
National Center for Complementary and Alternative Medicine
Nutrition in Complementary Care, American
Dietetic Association Dietetic Practice Group
USDA, Food and Nutrition Information Center, Dietary Supplements
U.S. FDA/Center for Food Safety and Applied Nutrition, Dietary Supplements