On February 3, 2010, Senators John McCain (R-AZ) and Byron Dorgan (D-ND) introduced a bill to the senate titled The Dietary Supplement Safety Act (S. 3002). The stated purpose for the bill is to make dietary supplements “safer,” despite the fact that dietary supplements are already hundreds of times safer than either prescription or over-the-counter drugs. What implications does this bill hold for consumers, providers, and industry?
In 1994, consumers won a major victory with the enactment of the Dietary Supplement Health and Education Act (DSHEA). Championed by Senators Harkin and Hatch, this landmark legislation is designed to protect access to safe, high-quality dietary supplements. Since 1994, many vocal opponents have challenged the value of the law and its ability to protect the public, as was evidenced in debates around the sale of ephedra and most recently, anabolic steroids. The transition a majority Democratic Congress, among whose leadership are many powerful detractors of DSHEA, has accelerated interest in reopening the law.
In 2007, Congress began to draw attention to the use of steroids by Major League baseball players. The Mitchell Report (authored by Senator George Mitchell, D-ME) documented steroid use by 89 Major League players, and contained a series of recommendations that were opposed by Major League Baseball. Hearings continued into 2008, when Major League Baseball player representative Don Fehr, at a hearing of a House Energy and Commerce Subcommittee, urged Congress to review DSHEA. Chairman Henry Waxman (D-CA), a longtime opponent of DSHEA, responded that he “hope[s] the Energy and Commerce Committee will reopen the DSHEA bill and take a look at its problems.”
The arrival of the Winter Olympics, in tandem with continued professional player scandals, has fueled concern regarding anabolic steroids and other illegal substances being marketed as dietary supplements. Now the FDA, with the United States Anti-Doping Agency (USADA) and the Drug Enforcement Agency (DEA), have issued statements before the Senate Judiciary Committee claiming a need for new authority to protect consumers. And here lies the problem with the McCain/Dorgan bill: Existing law allows for the government to ban illegal substances, remove adulterated product from the market, and ensure the safety of supplements. The addition of a steroid to a supplement makes it an unapproved or misbranded drug—not a supplement. The Food and Drug Administration (FDA) and the DEA have full legal authority, if not the financial resources, to enforce current law and successfully combat this problem.
If enacted, this legislation would repeal vital sections of DSHEA, giving the FDA full authority to select a discrete list of supplements that would remain available to consumers.
If enacted, this legislation would repeal vital sections of DSHEA, giving the FDA full authority to select a discrete list of supplements that would remain available to consumers. Simply put, the government would tell consumers and physicians what dietary supplements they could and could not buy—and even make many supplements illegal. This bill affects all dietary supplements, including vitamins, minerals, herbs, sports, and diet products.
Key provisions of the McCain-Dorgan proposed bill include the following.
- New facility registration requirements to identify all brands, products, and ingredients. The bill’s new registration requirements on dietary supplement facilities would establish that these companies disclose “all trade names under which the dietary supplement registrant conducts business [and] a list of all dietary supplements manufactured, packaged, held, distributed, labeled, or licensed by the facility.” Dietary supplement facilities would also need to identify all product ingredients and to submit all product labels. All required information would be required to be updated annually.
While all food facilities are now required to be registered with FDA, there is no current requirement for disclosure of products, brands, and ingredients, or for supplying labels. The bill would not extend such new obligations to any other foods.
- A revised definition of new dietary ingredients (NDIs) that would rely on an FDA-generated positive list of allowed ingredients. The bill would replace the definition of “new dietary ingredients.” Under DSHEA, a new dietary ingredient is defined as any ingredient that “was not marketed in the United States before October 15, 1994, and does not include any dietary ingredient which was marketed in the United States before October 15, 1994.’’ The bill would replace this definition by creating a list of “‘Accepted Dietary Ingredients,’ to be prepared, published, and maintained by the Secretary,” and define a new dietary ingredient as any ingredient not included on such list.
Revisions would also be made to the current new dietary ingredient notification process, such that even ingredients that are presently used in food and would be used for the first time in dietary supplements are subject to notification.
- Policing and record maintenance obligations for downstream manufacturers and retailers, who will be obliged to obtain written confirmation, from ingredient suppliers or from supplement brand marketers, respectively, of compliance with facility registration and product notification and rules. With regard to both facility registration and compliance with NDI regulations, the bill would establish a requirement for dietary supplement companies and retailers of supplements to “obtain adequate written evidence from the preceding responsible entity in the chain of commerce” that supplements they receive are registered as required under the facility registration rules, and that all NDI notification obligations have been met. All received evidence of such compliance would be subject to FDA review and inspection.
- Extension of existing adverse event report (AER) requirements, such that even minor AERs would need to be submitted to FDA annually. Dietary supplement marketers are currently required to submit serious AERs to FDA within 15 days of receipt. The McCain legislation would also require annual submission of a compilation report of all adverse event reports. This provision would establish a requirement that is similar to the current law for prescription drugs. Marketers of conventional foods have no AER requirements, even for serious adverse events.
- Obligations and authority for FDA with regard to removing products that present the risk of serious adverse health consequences or death, or are adulterated or misbranded. The bill would create a new responsibility for FDA to issue orders for a supplement company to cease distribution of any product for which FDA determines a “reasonable probability that a dietary supplement or a product marketed or sold as a dietary supplement would cause serious, adverse health consequences or death, or is adulterated or misbranded.” The agency would also be given mandatory recall authority. This new agency responsibility and authority now exists only for certain medical devices.
The American Association of Naturopathic Physicians (AANP), along with many other professional and trade organizations and the majority of supplement companies, has always been supportive of full implementation of DSHEA and the FDA’s authority to ensure supplements are safe. We believe manufacturers must be directly accountable for product safety. We support truth in labeling and advertising, and FDA’s establishment of Good Manufacturing Practices. Should the FDA determine that a dietary supplement constitutes a public health hazard, AANP supports the FDA’s right to remove it from the market immediately. AANP does not support any effort to restrict consumer access to supplements, vitamins, minerals, or herbs, nor do we support any effort to impose premarket approval for these products. To that end, we continue to promote full implementation of DSHEA and oppose S. 3002.
To write your Senators regarding S. 3002, please click here http://capwiz.com/naturopathic/issues/alert/?alertid=14692986
Additional information can also be found at Save Our Supplements http://www.saveoursupplements.org/
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Copyright © 2010 by the Natural Medicine Journal. All rights reserved. Contact Karolyn at Karolyn@KarolynGazella.com for more information.