The regulation of dietary supplements in the United States is primarily governed at the federal level by the Dietary Supplement Health and Education Act (DSHEA) of 1994. A substantial literary body supports the inadequacy of the regulation in ensuring product consistency, quality, and safety. Most dietary supplements are either known to be ineffective, or have never been tested for efficacy. With little oversight, and a low threshold for new products to enter the market, the dietary supplement industry has grown into a $30 billion business with over 90 000 products on the market today.[3, 4]
One strategy to achieving better regulation of dietary supplements may be the passage of more stringent state or local-level laws. Historically, few laws have been passed at the state level to regulate dietary supplements. However, the momentum and interest in state-level regulation is building. In 2008, and again in 2013, two large outbreaks of serious illnesses associated with dietary supplements re-ignited state-level public health concerns over dietary supplement safety.[5, 6] In April 2015, 14 state Attorney Generals (AGs) sent a letter to Congress requesting better federal oversight of dietary supplements. However, given that strong lobbying and political pressure by the dietary supplement industry have quashed past efforts by the Food and Drug Administration (FDA) to seek greater authority in dietary supplement regulation via Congressional action,[8-11] it remains to be seen what the impact of such a request will be.
While better federal oversight for dietary supplements remains essential, states may also proactively engage in regulatory activities to minimize harm from dietary supplements to their citizens. States interested in pursuing dietary supplement regulation may benefit from the experience gained in regulating other substances known to pose a risk to the public. For example, substantial progress has been made in the regulation of tobacco use at state and local level. Strategies and lessons learned from tobacco regulation efforts may be used to help states decide what to regulate and how to effectively overcome regulatory hurdles.
State governments are bestowed with ‘police powers’ to enact laws that protect the safety, health, and welfare of their populations. States may, through the passage of legislation, enforcement activities, or licensing restrictions, exercise their police powers to address gaps in federal regulation that place their citizens’ health and safety at risk.
Requiring retailers to obtain a licence or permit to sell specific products in the retail environment and to impose restrictions or requirements on those retail sales are typical state-level functions. A licensing approach is used by some states to regulate tobacco and alcohol sales, among other consumer products. State legislation that requires retailers to obtain permits or licences to sell dietary supplements serves multiple functions. First, such a mechanism provides states with a complete and comprehensive list of retailers who sell supplements within their jurisdiction; when a tainted or dangerous supplement is targeted for recall, supplement retailers are readily identifiable and accessible to state authorities. Moreover, states may use their licensing or permitting authority for enforcement. For example, critical violations that constitute a potential or actual threat to public health may be grounds for licence or permit suspension or revocation.[15, 16]
State legislation that mandates a licence or permit may include language on what types of enforcement actions may be taken on retailers with issued permits, as well as dictate the penalties or sanctions that apply to retailers in violation. For example, states could consider requiring retailers permitted to sell dietary supplements to prominently display warnings or other signage at the point of purchase, with penalties established for non-compliance.
States may also increase enforcement actions against dietary supplements companies using their existing authority. The Federal Trade Commission (FTC) Act prohibits deceptive marketing of products. All states and the District of Columbia have consumer protection laws in place that are similar to the FTC Act. The FTC has developed an advertising guide for dietary supplement manufacturers that explains the criteria it will use in determining whether a particular claim is misleading. Using similar criteria, state AGs, using their own authority to investigate and uproot deceptive marketing practices, may identify potentially misleading claims by supplement manufacturers and take enforcement action as needed.
Larger states may have adequate resources, or states may pool resources, to additionally conduct laboratory testing to identify misbranded or adulterated products,[14, 17] and ban products that are demonstrated to be unsafe. In addition, state AGs may warn consumers about dangerous products and initiate public health education campaigns.
In February 2015, the New York State Attorney General, Eric T. Schneiderman issued letters to GNC, Target, Walmart, and Walgreens to cease and desist sales of mislabelled store- brand dietary supplements that either included known allergens not disclosed on the label, or failed to contain the active ingredient(s) listed on the product label. However, New York State's testing methodology, which relied on DNA barcoding, was subject to heavy backlash by the industry, and criticized for being inappropriate and inadequate.[21, 22] Despite the controversy, the effort was successful in drawing national attention to widespread problems associated with dietary supplement safety and quality. Moreover, the state of New York reached an agreement with GNC to implement DNA barcoding on all active plant ingredients sold in products in over 6000 stores nationwide, thereby facilitating the voluntary adoption of an ingredient verification standard by an industry leader that surpasses the established minimum requirements of DSHEA.
In another state-led effort, the State of Oregon tested dietary supplements labelled as containing Acacia rigidulus after an independent study concluded that a dangerous amphetamine-like stimulant called β-methylphenylethylamine (BMPEA) remained in a substantial fraction tested over a year after the FDA reported these findings.[25, 26] Oregon's analysis confirmed these results. Subsequently, Oregon and Vermont reached an agreement with Vitamin Shoppe, a leading dietary supplement retailer, to permanently ban the sale of products containing BMPEA nationwide. Once again, the agreement expanded on the industry's responsibility by placing the burden of confirming the absence of the adulterant in products sold on the retailer.
State legislation may provide enforcement actions in the absence of federal action. The FDA began receiving adverse event reports on products containing ephedrine alkaloids in 1993; in 1994, it began issuing medical bulletins to warn consumers of the risks associated with ephedrine use. However, it took nine years, 155 deaths, and nearly 17 000 adverse event reports before the FDA banned products containing ephedrine. Astonishingly, a year later, a federal judge overturned a part of the ban; the ban was permanently reinstated in 2006.[10, 14, 28] Frustrated by the slow federal response, many states passed laws restricting access to ephedrine.
Another example of a particularly dangerous compound detected in several sports supplements is 1,3-dimethvlamylamine (DMAA). DMAA is a stimulant with properties of both ephedrine and amphetamine that has been associated with multiple deaths and is banned in several countries.[30, 31] During the 2013/2014 legislative session, a bill introduced in New York sought to ban the sale and distribution of dietary supplements containing DMAA; despite a unanimously favourable vote from the New York Senate, the bill died in assembly.[32, 33]
By contrast, the local government in Suffolk County, New York, was a pioneer in banning the sale of pure caffeine powder, another dangerous dietary supplement associated with two well-publicized deaths.[34, 35] The success in Suffolk County spurred additional efforts at the state level by Ohio, Illinois, Maryland, Mississippi, New Jersey, New York, and Rhode Island; subsequently, Ohio became the first state to ban the sale of pure caffeine.
A one-supplement-ingredient-at-a-time approach to dietary supplement regulation and enforcement is inadequate because of the pervasiveness of safety and quality issues that have been documented. While more difficult to pass, broader state legislation that increases regulatory control over all dietary supplements, or at least specific classes of dietary supplements, is needed.
Historically, states have successfully passed laws grounded in core public health policy areas. For example, laws passed to regulate tobacco have restricted the age for purchasing tobacco products, limited access to tobacco products by youth, placed limits on advertising, and taxed cigarettes. Some or all of these strategies may be useful in regulating dietary supplements at state level. Restrictions may selectively be passed for certain classes of dietary supplements that pose the greatest threat to public health. A bill in Massachusetts introduced in the 2015/2016 legislature (House Bill H.3471) embodies many of these well-established public health policy strategies. It specifically targets weight loss and muscle building supplements, and seeks to prohibit their sale to minors, limit their access by requiring them to be placed in a locked cabinet or behind the counter, and require conspicuously displayed notices warning consumers about the dangers associated with using certain dietary supplements. The fate of this bill remains unknown at this time.
Finally, states and local governments interested in dietary supplement regulation must remain vigilant to the impact of direct-to-consumer sales, such as those made through online retailers; it is estimated that approximately 4% of dietary supplement sales occur online. To limit direct-to-consumer tobacco sales in the absence of federal regulation, 34 states have passed targeted legislation mostly focused on preventing tax evasion or to restrict sales to youth; however, implementation and enforcement of these laws have proven to be a substantial challenge. States have enjoyed greater success in using other strategies to impact online sales; for example, a voluntary agreement by major credit card companies to not process transactions with internet-based tobacco companies has had a substantial impact.
Legal challenges by the industry
State legislative authority may be limited by federal preemption, and similarly, governments attempting to regulate supplements at the local level may be subject to state-level preemption. Preemption is a process by which the legislative authority of one level of government is overruled by a higher level of government; local laws may be preempted by state laws, and state laws may be preempted by federal law.[14, 42] Preemption may be expressly included in law, or implied. The Nutrition Labeling and Education Act (NLEA) contains language that expressly prohibits states from imposing requirements that are inconsistent with the act for foods, including dietary supplements, but arguably, the preemption may not extend to states’ ability to require warnings about the supplement's safety. If it can be inferred that Congress intended to exclude parallel or competing state regulation, preemption may be implied even in the absence of specific preemption language.[14, 42]
Preemption can undo years of legislative effort at the state and local levels. The tobacco industry successfully preempted laws in 32 states, invalidating dozens of local laws and preventing hundreds of others from being passed. Internal documents released as part of the Master Settlement Agreement (MSA) revealed that the industry was threatened by local anti-tobacco efforts and did not have the resources necessary to maintain its status quo at the local government level; concentrating the locus of control at the state and federal level through preemption was a strategy for success, as the industry had substantially greater influence at higher levels of government, and could lobby for weaker laws with little impact. A public health strategy to proactively disallow preemption is the explicit inclusion of an anti-preemption clause into the statute.[17, 44]
Although DSHEA does not explicitly contain preemption language, Congressional intent behind passing the law was to increase access to dietary supplements.[1, 43] Therefore state and local regulations that restrict access to supplements may arguably implicate preemption. Dietary supplement advocates are well-versed in crying preemption; time and again, they have lobbied against the FDA's attempts to impose stricter regulations by arguing that the FDA's efforts contradict Congressional intent.[45, 46] Preemption may be the industry's strategy for gutting state laws imposing stricter safety regulations or restricting the age of access to dietary supplements.
A second potential source of interference in state and local legislation is the Commerce Clause of the Constitution.[43, 47] Any legislation that places an unreasonable burden on interstate commerce may theoretically violate the Commerce Clause. When legislation passed places additional burdens on commerce, the benefits of the law must be weighed against the burden imposed by the law.[14, 43, 47]
The tobacco industry has attempted on multiple occasions to invoke the Commerce Clause to justify the repeal of state laws imposing stricter requirements, with mixed results. The tobacco lobby was successful in repealing a law in Massachusetts requiring a health warning label on cigars by arguing that the law unreasonably impeded interstate commerce. On the other hand, the courts rejected a Commerce Clause argument against a Massachusetts law requiring cigarette manufacturers to release ingredient information. The Commerce Clause will likely be used to protect manufacturers from having to implement more stringent manufacturing or safety standards for dietary supplements based upon the argument that the standards interfere with interstate commerce.
Third, the First Amendment protects manufacturers' rights to commercial free speech. The First Amendment is predicated on the belief that individuals are sovereign beings capable of making decisions in their own best interest; thus, First Amendment principles may contradict attempts to regulate marketing and labeling practices by regulatory agencies, even if undertaken in the interest of public health. The tobacco industry has used First Amendment challenges to avoid restrictions on their marketing practices. In 2012, courts agreed with R.J. Reynolds that graphic images and warnings on all cigarette boxes required by the FDA, as authorized by the Family Smoking Prevention and Tobacco Control Act of 2009, violated the manufacturers’ First Amendment rights; the requirements were subsequently withdrawn by the FDA.
The dietary supplement industry has been fairly successful in using First Amendment challenges to resist regulatory control over its marketing practices. In 1999, a dietary supplement manufacturer challenged the FDA's refusal to allow certain health claims to be made about its product on the grounds that the claims lacked significant scientific agreement, stating that the FDA's decision interfered with its First Amendment rights; the US Court of Appeals found the argument to be meritorious. The court differentiated between inherently misleading claims, which are not protected by commercial free speech rights, and potentially misleading claims, which warrant greater consideration.[48, 50] In a decision that represented a critical shift in legal opinion, the court noted that permitting manufacturers to display claims while including a disclaimer was less restrictive, and therefore more consistent with First Amendment protections for dietary supplement manufacturers.[50, 51] States that pass laws restricting marketing practices or claims made by supplement manufacturers may need to be prepared to defend against First Amendment challenges in court.
Other industry tactics
Not much is known about the strategies used by the dietary supplement industry to protect its financial interests. The tobacco industry's strategies only became obvious when millions of pages of internal documents were released as part of the 1998 Master Settlement Agreement (MSA). Several decades ago, major manufacturers in the tobacco industry joined forces to achieve mutually beneficial goals. One organization, the Council for Tobacco Research, appeared to be a neutral and independent body, when in fact it conducted industry-funded research that supported the industry's position. The industry suppressed research on the risks associated with smoking, jeopardized governmental funding that supported anti-tobacco researchers, attacked research that did not support tobacco sales, paid researchers and consultants to publish studies with favourable findings, and used its own research to bias policymakers. The industry established groups that promoted tobacco use and targeted media messages to vulnerable audiences. It spent millions of dollars on lobbying efforts. For example, it paid firefighter associations in New York to oppose a bill requiring cigarettes to be fire safe.
Many industries besides the tobacco industry have utilized tactics such as funding, publishing, and disseminating research favouring industry interests; suppressing, attacking, or distorting findings that reflect poorly on the industry; lobbying for regulatory and scientific standards that protect the industry's interests; and establishing relationships with politicians to protect their financial interests.
While the tactics of the dietary supplement industry are not known, many superficial similarities to strategies used by industries who wish to avoid regulation and negative publicity are evident. The industry has multiple lobbying organizations. For example, the Council for Responsible Nutrition, a Washington-based trade organization of the dietary supplement industry claims to be ‘The Science behind the Supplements’. Together, the trade organizations representing the industry have thwarted multiple efforts by the FDA to enhance regulatory control over dietary supplements. In 2014 alone, the nutrition and dietary supplement industry spent $4 million on lobbying efforts, and contributed $1.1 million to federal candidates, parties, and outside groups. US Senator Orrin Hatch, who has successfully opposed several legislative attempts to establish tighter regulatory standards for dietary supplements, is a long-time supporter of the industry.
Building momentum and support
Unlike the tobacco industry which was built around a single unifying product with associated health risks first identified in 1950, the dietary supplement industry represents a heterogeneous body of substances with varying risk profiles, modified by the identity, purity, and integrity of the ingredients used in production. Vitamins, for example, may be safe for consumption at the daily recommended dose but be rendered toxic at high doses, or when contaminated or adulterated with other ingredients. On the other hand, other dietary supplement ingredients such as 1,3-dimethylamylamine (DMAA) may themselves be dangerous products.[2, 57] Moreover, dietary supplements are sold and taken as products that benefit health. Therefore, carte blanche statements about the lack of safety of dietary supplements are easily refuted by the industry and are not likely to receive much consumer support.
Much like the groundswell of anti-tobacco efforts that helped organize the public health movement in support of tobacco policy, ‘safe supplement’ supporters need to coalesce, at local, state and/or national level, to develop a well-organized approach to achieving better regulation of dietary supplements. The recently formed coalition of 14 state AGs that promises greater oversight of the dietary supplement industry is indeed an important step in the right direction. Successful legislative efforts in regulating the sale of pure caffeine powder, first in Suffolk County, New York, and then in the State of Ohio, along with a flurry of bills under consideration in several other states suggests that like tobacco, much success in regulating dietary supplements can be achieved by starting at the local level. However, in learning from the tactics of the tobacco industry, local efforts in dietary supplement regulation must take precautions, such as the introduction of language that disallows pre-emption. States or local governments without legislative or public support may pursue less aggressive strategies such as providing an open public comment period to solicit concerns and questions or creating a website to serves as a clearinghouse for the dissemination of safety information on dietary supplements.
Supporters of supplement safety may begin their probes by focusing on the industry's worst offenders. For example, supplements marketed for sexual enhancement, sports enhancement/body building, and weight loss are the most commonly recalled dietary supplements; moreover, 85% of sports enhancement products, 67% of weight loss products, and 20% of sexual enhancement products continue to contain adulterants years after they have been recalled. The literature therefore supports treating these products as classes of dietary supplements at particularly high risk for safety issues in need of enhanced regulation and restriction. A focus on classes of dietary supplements with particularly egregious safety issues, as attempted by Massachusetts’ House Bill H.3471, is likely to increase consumer support for greater regulation and oversight.