Wielding the sword of professional ethics against misleading dietary supplement claims
2 The Hastings Center, Garrison, NY
3 Graduate Program in Bioethics, Union-Mount Sinai University, Schenectady, NY
4 Hastings Center, Inc., Garrison, NY
1 To whom correspondence should be addressed: e-mail: murrayt{at}thehastingscenter.org and torokc{at}thehastingscenter.org
Received on February 12, 2008; revised on May 1, 2008; accepted on June 4, 2008
What does the word "glyconutrient" mean to you? If you are a glycobiologist studying the complexities of cell communication facilitated by the interaction of sugar molecules attached to fats or proteins within the body, the term may have little meaning. While "glyco" is commonly understood to mean sugar, nutrient is somewhat more nebulous, referring loosely to an ingredient that supports life.1 Considering that glycobiology involves the complex interaction of an array of individually identified sugar chains that dominate the surface of cells and proteins and combine to contribute to cell creation and function, the term glyconutrient by itself does little to articulate meaning or purpose.2
Conversely, if you are a consumer searching for alternative or complementary medicines (CAM) to promote well-being or arrest disease, the scientific-sounding label may generate a feeling of security and credibility. Capitalizing on America's love of science, many dietary supplement manufacturers resort to scientific jargon when labeling their products. Mannatech, Inc., for example, capitalized on the term "glyconutrient," to describe product ingredients purported by the company to supplement the body's essential sugars. Despite the lack of acceptance among many glycobiologists of the term, the result to Mannatech was reported annual revenue for 2007 exceeding $215 million and a multilevel marketing structure of over 500 thousand independent salespeople.3
Appeals to unsubstantiated science or unrelated published research, another common marketing tactic for savvy manufacturers, may escape immediate detection despite the combined watch of the Federal Trade Commission (FTC), Food and Drug Administration (FDA), and regulations under the Dietary Supplement Health Education Act (DSHEA). Many glycobiologists have opened email or answered calls from confused or hopeful consumers looking for verification that "glyconutrients" can cure cancer or mitigate disease—claims made in product testimonials found on company web sites. While references on the web sites do not directly link researchers to unsupported claims, having their name listed with research they conducted on unrelated topics implies a relationship to the claim that is unsettling to many scientists. According to some glycobiologists, such implications denigrate the field of study and could potentially limit access to necessary research funding, especially if the field becomes linked to a product under investigation.4 More distressing, the unsolicited inquiries place researchers in the uncomfortable position of having to explain to the parent of an ill child or a patient dying of cancer that the science of glycobiology has no documented correlation to the claims made in marketing materials fueling the inquiry. The concerns extend beyond personal discomfort on the part of scientists. Many consumers may be foregoing conventional medicine, or taking dietary supplements that could potentially interfere with standard therapies based on misleading references to the work of well-regarded scientists.
The FDA and FTC are aware of such potentially fraudulent activities and urge public diligence in reporting inflated claims. Even for medical professionals, sorting through the glut of conflicting theories and marketing ploys can be a significant barrier to discovering the truth. Distinguishing established facts from scientifically disputed claims requires a sophisticated understanding of the science—an understanding normally attributed to the researcher in a particular field. Recognizing that 62% of adults use some form of CAM and that relaxed regulations of dietary supplements leave consumers especially vulnerable to marketing strategies rife with complex scientific jargon, what more can and should researchers do, individually and collectively, to protect professional integrity, maintain public trust in the underlying science, and promote public welfare?
For scientists who want to take a more prominent role in protecting integrity of the science and the public's interests, it is helpful to understand how dietary supplements are currently regulated. In general, the FDA oversees the safety, manufacturing, labeling, and product literature for drugs and medical devices, while the FTC regulates how the products are marketed. In 1994, controversy over Congress’ attempts to enact legislation that would provide greater agency control over the manufacture and marketing of dietary supplements previously regulated under the Food, Drug & Cosmetic (FD&C) Act culminated in the enactment of DSHEA. Responding to intense lobbying from interest groups and public concern that tighter controls would restrict access to vitamins, the enactment of DSHEA provided for a broad reclassification of dietary supplements. Categorizing supplements as foods rather than drugs, the definition included not only vitamins and minerals but also categories and combinations of herbs, botanicals (with the exception of tobacco), amino acids, concentrates, metabolites, constituents, extracts, or combinations thereof.5
Under the FD&C Act, drugs are defined by their intended use, such as the ability to diagnose, cure, mitigate, treat or prevent disease, and their ability to affect the body's structures or functions, exclusive of foods.6 While many argue that the distinctions drawn between drugs and dietary supplements are more semantics than science and actually weaken efforts to protect consumers, the details of the debate deserve prior attention in a separate commentary.7 For purposes here, it is enough to note that currently drugs are governed under the FD&C Act, while dietary supplements are regulated under DSHEA.
What does this mean to the savvy manufacturer and lay consumer? Whereas drugs must pass strict regulatory standards establishing both their safety and efficacy before they can be marketed to the public, dietary supplement manufacturers must only demonstrate that their products are safe. Unfortunately, what evidence is required to substantiate the safety claim is not clearly defined. Consequently, the burden of proving that a product poses an "imminent hazard" rests on the FDA, after the product has reached the market and significant harm is identified. Despite numerous complaints about Ephedra-based products, for example, it took the FDA 7 years before it had enough proof to finally issue the ban in 2003.
Product labeling and advertising standards permitted under DSHEA pose another area of potential abuse by manufacturers and confusion for the lay consumer. While clear prohibitions exist against express or implied claims that a product can cure or affect a specific disease, license is given for assertions that taking a dietary supplement can improve conditions that may be associated with a disease. Puzzling as it may sound, the explanation is even less clear when applied in practice. For example, where claims that taking a product will alleviate symptoms of Multiple Sclerosis would violate the labeling statute, there would be no sanctions for statements that the product can promote a "healthy immune system." Likewise, where a product cannot purport to treat chronic urinary tract infections, it may be acceptable to advertise products that maintain "healthy urinary systems." Such assertions, even with the required disclaimers that the product is not intended as a food substitute and has not been approved by the FDA, may be difficult for a consumer to interpret. Adding to the confusion, dramatic testimonials that exalt the benefits of a dietary supplement may be within the protection of First Amendment commercial speech; but such advertisements do little to enlighten the consumer about the product's proven effectiveness or even its safety.
Recent amendments have improved the FDA's ability to regulate the manufacture and labeling of dietary supplements, ensuring that consumers are ingesting the actual quantity, strength, and purity of products described on the label.8 Moreover, packaging, holding, and processing standards previously unspecified for dietary supplements were recently added, thus lessening the risk of contamination and impurities in the manufacturing process. Additionally, new legislation amending the FD&C Act requires manufacturers or others listed on a products’ label to report serious adverse events to the FDA and allows the FDA to review records of all events reported and maintained by a manufacturer for at least 6 years.9
Most significantly in terms of consumer information and research for CAM products, the Office of Dietary supplements established under DSHEA works closely with the National Center for Complimentary and Alternative Medicines (NCCAM) and other centers under the National Institute of Health to support and disseminate research and information regarding the safety and efficacy of specific dietary supplements.10 Although the centers have no authority to mandate strict research protocols for nongovernment funded studies, working with the FDA, the centers are able to investigate and award grants for the study of any product reported to the FDA as having produced adverse events.
However distressing it can be for a scientist to discover that his or her unrelated research has been referenced in a company's marketing campaign, the complex intersection of intellectual property law, First Amendment rights, internet law, and the lack of clear tort liability provides no clear path for pursuing individual legal action. In general, without some evidence that the researcher's personal or financial interests were directly infringed upon, there may be no standing for an individual suit. Nevertheless, scientists can be a powerful resource for stopping fraudulent practices and insuring the integrity of their reputation and field of study.
Despite the David and Goliath overtones, individual scientists can help stop multimillion dollar companies from profiting from misrepresenting the implications of scientific research by reporting potentially fraudulent activities to state and federal agencies. Sales for Mannatech, Inc., for example, dropped 50% since 2006, down from $400 million, perhaps due to consumer complaints filed with the FTC and other actions for fraudulent advertising. Moreover, the recent filing of charges by the Texas Attorney General in July 2007, for alleged violations of state Deceptive Trade Practices Act and the state's Food, Drug & Cosmetic Act, was followed by the company shutting down its primary consumer education web site, conceivably affecting sales even further.11
In addition to reporting potential abuses, individual scientists can further protect the integrity of their work by only submitting their publications to journals which maintain a sound conflict of interest policy. Moreover, publishing rebuttals in well-read journals when the scientist becomes aware of egregious misuses of his research would also help identify misleading references, as well as acquaint a wider audience with the science in question.
Lastly, acknowledging the reality that consumers may request information regarding potential applications of a scientist's work, the scientist should be ready to answer the inquiry. Enlisting the help of their professional society, an issue addressed in the next section, scientists should be prepared to offer informational materials prepared by the scientific society or direct consumers to materials that can clearly articulate the facts about the science and encourage the consumer to report claims against manufacturers who misrepresent scientific findings. Included in the information might be the web sites and contact information for the FTC and FDA, as well as for NCCAM and Office of Dietary Supplements (ODS), so that consumers can check if the dietary supplement in question has undergone safety and efficacy testing under government standards.
The scientific community's role
A community of scientists, like the Society for Glycobiology, has many opportunities as a collective organization to promote public welfare and combat egregious practices that threaten to defame the integrity of their science. First, scientific societies must operate on a shared sense of values, often articulated as a code of ethics. A scientific society committed to its values and willing to self-regulate presents a professional and trustworthy persona to the public and provides standards of excellence to guide its individual members. While bylaws and regulations describe the function of the scientific society, such as qualifications for membership and voting rights, a code of ethics should reflect the mission and purpose and may describe behaviors that support the society's goals. Membership in the scientific society, therefore, requires more than a payment of dues—it demands a commitment to promote the scientific community's values, through individual and collective behavior and to address activities that negatively impact the integrity of the science, for the good of the individual member and the scientific society in general.
Three key examples where a scientific society may take action are (1) when work published by individual members is used to support unsubstantiated and unrelated claims; (2) when public trust is jeopardized by misunderstandings about the science and potential applications; and (3) when public welfare is threatened by harmful misunderstandings about products such as dietary supplements. One way a scientific society can address misrepresentations would be to alert members to suspect advertising and adopt strategies for reporting egregious behavior to the proper governmental authorities. Additionally, a committee could be established to develop informational materials that members could use when responding to inquiries from the lay public. Alternatively, the materials could be posted and updated on the scientific community's web site so that consumers could be directed to the information. Depending on the scope and magnitude of the misleading advertising, the society may want to take a public stance and publish a collective statement countering the misuse.
Preventing the public's mistrust of the science that may stem from a lack of credible information and fraudulent representations requires proactive steps. One such measure could be to develop educational materials and training activities that could be used by medical schools and professional societies like the AMA, to help ensure that doctors and medical students have the facts to counter dubious claims. Doing so not only addresses the lack of credible information concerning dietary supplements available to the public, but also establishes the scientific society as a professional and respectable resource for other professionals.
Protecting the public's welfare from harm due to mislabeling or inadvertent misuse of dietary supplements falls within the reach of governmental oversight and regulation; even so, professional societies can and should step into the breach if it appears that current legislation is inadequate to protect consumers. While the FDA sets standards for proper labeling and manufacturing of dietary supplements, the fact remains that little is known about the effectiveness of various supplements and virtually no data exist for determining adequate dosages for children. In practice, calls to glycobiologists like those previously mentioned often concern a parent's desire to find a cure for their ill child. Children are not just small adults in terms of dosage; the potential for harm increases when untested dietary supplements are administered to children. Moreover, recognizing that even benign substances like vitamins taken in excess can prove harmful, professional societies should remain open to opportunities to advocate for change or influence others to do so—especially if they feel that their own efforts to correct public misunderstanding are inadequate.
Throughout this discussion several groups were identified as the victims of some questionable marketing practices of dietary supplement companies, potential agents in combating the abuse, or both. Consumers, medical professionals, individual scientists, and scientific societies all have something to lose if fraudulent practices go unaddressed and much to gain by taking personal responsibility for preventing and addressing misleading information that affects consumer health. While governmental oversight and regulation is a critical component for monitoring and thwarting illegal practice, public awareness, self-education, and reporting potential fraud to state and federal agencies are the key components in the battle against vendors who misappropriate and misrepresent science. Where medical professionals, scientists, and the government can help is in addressing consumer inquiries with credible information. Lastly, for scientific communities, the willingness to adopt and enforce ethical standards to combat egregious abuse protects the societies’ members, the integrity of the science, and the public's trust. Consumers, medical professionals, scientists, scientific organizations, and governmental agencies can wield a mighty and effective sword working together as partners to bring truth and accuracy to the claims made by those seeking to prey on hope and fear.
None.
Conflict of interest statement
None declared.
Footnotes
1 Nutrient. Dictionary.com. The American Heritage® Science Dictionary. Houghton Mifflin Company. http://dictionary.reference.com/browse/nutrient (accessed: November 27, 2007). 
2 USCD, Glycobiology Research and Training Center, http://grtc.ucsd.edu/whatis2.html (visited November 2007).
3 Forbes.com http://finapps.forbes.com/finapps/jsp/finance/compinfo/CIAtA Glance.jsp?tkr=MTEX (visited November 2007).
5 Public Law 103-417, DSHEA 
3.
8 21 CFR part 111 (describing the Current Good Manufacturing Process (cGMP) added for dietary supplements, which were previously governed by the cGMP defined for foods).
9 Dietary Supplement and Non-Prescription Drug Consumer Protection Act (the "AER bill"), S. 3546.
10 DSHEA 13; see also NIH, "National Center for Complimentary and Alternative Medicine" at http://nccam.nih.gov/about/, (visited November 2007) (NCCAM was established under Title VI, Section 601 of the Omnibus Appropriations Act of 1999 (P.L. 105-277)).
11 Texas v. Mannatech, Inc., et al. (Pet. at 1-47, July 2007).
Abbreviations
CAM, complementary medicines; DSHEA, Dietary Supplement Health Education Act; FDA, Food and Drug Administration; FD&C, Food, Drug & Cosmetic; FTC, Federal Trade Commission; NCCAM, National Center for Complimentary and Alternative Medicines
References
Kaiser J. Who owns glycobiology? Science (2007) 318:734–737.
Cohen PJ. The Dietary Supplement Health and Education Act: Regulation at a crossroads. Science, politics, and the regulation of dietary supplements: It's time to repeal DSHEA. Am. J. L. Med (2005) 31:175–224.
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