A Survey of the Dietary Supplement Labeling Act of 2011

Last June, Sen. Richard Durbin (D-IL) introduced the Dietary Supplement Labeling Act of 2011 (DSLA, S.1310, 112th Congress), which is purportedly designed to regulate aggressive and unsubstantiated dietary supplement structure-function and health claims, promote transparency and improve the safety of dietary supplements." While the provisions of DSLA do not directly address unsubstantiated structure-function claims, Sen. Durbin issued a press release in May 2012 expressing his concernand arguably legislative intentregarding structure-function claims on marketing collateral and product packaging. He cited the inclusion of melatonin in Lazy Cakes as an example of a food product that abused existing food labeling rules, and later identified energy drinks, such as Rock Star Energy Drink and 5-Hour Energy, as products of concern because of their flashy advertising." According to Sen. Durbin, all of these products presumably induce the American public to purchase products that contain potentially unsafe additives." As such, the proposed legislation requires FDA to clearly define the term conventional food," in an effort to narrow the definition of dietary supplements" and engender greater transparency.

Aside from the bills redefinition of conventional foods," which will not only affect products such as Lazy Cakes and energy drinks, DSLA also imposes burdensome and unnecessary regulations on manufacturers of traditional dietary supplements (i.e., firms that manufacture products that are commonly considered dietary supplements by the lay consumer public). DSLA amends section 415(a) of the Food, Drug and Cosmetic Act (FDCA) as codified in 21 U.S.C. § 350 (d)(a), and mandates that manufacturers register (1) a description of each dietary supplement manufactured by the facility, (2) a list of all ingredients for each dietary supplement manufactured, and (3) a copy of the product label. DSLA also requires that FDA be notified within 30 days each time a manufacturer produces a new dietary supplement, reformulates or discontinues a product.

Moreover, DSLA amends section 411 of FDCA and directs the Secretary of Health and Human Services to compile a list of dietary supplement ingredients and proprietary blends that might be connected with serious adverse effects." DSLA also requires the government to enter into a contract with the Institute of Medicine (IOM), which will be responsible for issuing a report of dietary supplement ingredients that might be connected to potentially serious adverse events," among other things. Products that contain ingredients that potentially cause negative events will require the inclusion of standardized warning labels. If the ingredient is a component of a proprietary blend, that ingredients dosage must also be disclosed along with other label requirements.

Although Sen. Durbins goal of defining conventional food" and regulating dubious health claims is worthwhile, additional legislation is not the solution. Existing statutory laws, promulgated regulations and proposed regulatory guidelines already achieve the desired end result. DSLA will not yield greater public health or safety. Instead, DSLA will only negatively and materially affect the way traditional dietary supplement manufacturers operate because it will impose unnecessary bureaucratic requirements on the government's already overtaxed quality personnel. Generally, only enforcement of laws can ensure unlawful and harmful conduct does not occur. In this particular instance, enforcement of existing laws is the root solution, and holding FDA and FTC more accountable is the prudent approach to arriving at that solution. For example, whether a food product is unlawfully being marketed as a dietary supplement could be an example of unfair or deceptive acts governed by the Federal Trade Commission Act (FTCA).

Pursuant to 15 U.S.C.A. § 45(a)(1), FTC is charged with preventing unfair or deceptive acts or practices in or affecting commerce." Under FTCA, product claims must be substantiated by competent and reliable evidence." Similarly, the Dietary Supplement Health and Education Act of 1994 (DSHEA) requires structure-function claims be substantiated to show they are truthful and not misleading." The Nutritional Labeling and Education Act of 1990 (NLEA) defines a health claim" as any claim made on a dietary supplement label that expressly or impliedly characterizes the relationship" between the dietary supplement and a health related condition." Health claims must also be substantiated by the totality of publicly available scientific evidence" and must be complete, truthful, and not misleading."

Recently, the First Circuit and the Eleventh Circuit affirmed the district courts and FTCs holding against Direct Marketing Concepts and Hi-Tech Pharmaceuticals for making unsubstantiated structure-function claims. Similarly, Airborne notoriously agreed to settle FTC charges of unfair and deceptive advertising for $30 million in 2008 because it used unsubstantiated cold prevention and germ-fighting claims for its eponymous product. Walgreens followed suit two years later and settled with FTC because it also used unsubstantiated cold prevention and germ-fighting claims for its comparable private label product. Later, FTC also ruled dietary supplement firms could not hide behind DSHEA to make unsubstantiated structure-function claims

FTCA directly addresses claims substantiation and unfair and deceptive product packaging. FTC is equipped with legal precedent and the authority to prosecute energy drink manufacturers flashy advertising" in an effort to protect the public from health or safety risks. FTC has sufficient authority to regulate unlawful marketing claims. More specifically, these cases illustrate how FTC and the courts have successfully exercised that power to safeguard public health and safety from firms that abuse existing trade labeling laws, which also govern quasi- or pseudo-dietary supplement products such as Lazy Cakes. If a products marketing or packaging satisfies FTCA rules for unfair or deceptive acts, FTC should intervene to ensure the consumer public is not manipulated or exploited.

DSLA also imposes substantial redundant reporting requirements on dietary supplement manufacturers. The Bioterrorism Act of 2002 already requires all food processing facilities to register with FDA. Food and drug processing facilities are required to register with state and local governments. FDA has also issued multiple versions of its draft guidance regarding adverse reporting requirements for dietary supplement manufacturers. The 2009 version suggests dietary supplement manufacturers report serious adverse events to the Secretary of Health and Human Services within 15 business days of the event. And last year, President Obama signed the Food Safety Modernization Act (FSMA) to further protect the public from unsafe dietary supplements. FSMA expanded FDAs powers governing new dietary ingredients and allowed it to detain potentially unsafe dietary supplements for up to 30 days. FSMAs provisions also require FDA to notify DEA whenever a new dietary ingredient application lacks sufficient substantiation to show the ingredient is free from certain steroid analogs. Accordingly, DSLA duplicates some of the spirit of these existing requirements under the Bioterrorism Act and FSMA.

Indeed, Sen. Durbins proposal and approach is not new. In 2010, Sen. John McCain (R-AZ) failed to gain traction for his Dietary Supplement Safety Act (DSSA), which attempted to abrogate elements of DSHEA and impose unnecessary laws. DSSA failed after Sen. McCain realized the proposed legislation was redundant and ineffective. To be sure, DSLA is no different. Yes, the provisions are not the same. However, FDA has conducted only a handful of dietary supplement GMP (good manufacturing practice) audits since, and industry-wide enforcement of current rules and regulations remain limited. If lawmakers are genuinely interested in safeguarding the public from unsafe dietary supplementsincluding products such as Lazy Cakes and some energy drinksthey should allocate more resources to FTC and FDA so enforcement of existing laws and regulations is more uniform, and prosecution of firms engaging in unlawful conduct is swift and frequent. Greater enforcement of existing laws and regulations will make a material positive impact on public health and safety in the near term. Additional legislation will not magically preclude manufacturers and marketers from distributing dietary supplement products with aggressive or unlawful health claims. More facility registration will not solve the problem, and IOM research reports will be useless without better enforcement. Legislators such as Sen. Durbin should focus their attention on holding FTC and FDA accountable for enforcing myriad statutes and regulations that are already on the books before pulling the figurative legislation trigger. Similar to Sen. McCains DSSA, Sen. Durbins DSLA should be abandoned as proposed.

Shafiel A. Karim is a director at NHK Laboratories Inc., a GMP-certified contract manufacturer of private label dietary supplements. Karim earned a bachelor's of arts from California State University, Fullerton, an master's of arts from California State University, Long Beach, an master's of business administration from the Peter F. Drucker and Masatoshi Ito Graduate School of Management at the Claremont Colleges, and is currently a jurus doctor candidate at Southwestern University School of Law.