Leaders in holistic and integrative medicine foresee tighter regulation of the dietary supplement and natural products industries in the near future, and some say that might not be a bad thing.
Speaking at a panel on policy and legislation at the 2010 Integrative Healthcare Symposium (IHS), thought-leaders in the field voiced their views on a host of issues, including oversight of the nutraceuticals industry.
Though holistic physicians are, for the most part, supportive of free access to nutritional supplements, botanical medicines, homeopathics and other natural products, they are concerned about gaps in quality. The issue is significant because supplements play a big role in integrative practice. Some doctors fear patients could be hurt by poorly made products, and that there could be medicolegal consequences in such cases. On the other hand, increased regulation might make it harder for patients to get beneficial products.
McCain in Vain
The issue came to the fore last winter, when Sens, John McCain (R-AZ) and Byron Dorgan (D-ND) introduced a bill to increase FDA regulatory powers over the supplement industry. Among other things, the proposal would have required that even minor supplement-associated adverse events be reported to the FDA (current rules mandate reporting of serious events), and would have increased FDA authority to remove products that are adulterated, misbranded or present serious health risks.
The McCain-Dorgan “Dietary Supplement Safety Act (S.3002) was blasted by industry representatives, many holistic practitioners, and public advocates of health freedom who claimed it was using a “consumer protection” rationale to bludgeon an industry that actually has a very good track record for product safety (see New FDA Data Underscore Supplement Safety & Fast Action When Problems Arise).
McCain’s move was vilified by some on the Right as unnecessary government meddling, and others on the Left as a ploy by Big Pharma and conventional medicine to strangle health care alternatives. The senators promptly withdrew the bill in February. But many in the field say increased regulation is inevitable.
“If it’s not the McCain proposal, it will be something else,” predicted Wayne Jonas, MD, director of the Samueli Institute, a think-tank on integrative medical practice and policy. Dr. Jonas was formerly director of the federal Office of Alternative Medicine, now known as the National Center for Complementary & Alternative Medicine (NCCAM) within NIH. He believes regulatory change is bound to happen, “because there is a real need for some change.”
Sens. McCain & Dorgan say their proposal was motivated by the desire to control drug and steroid-containing “performance enhancement” products illegally sold as dietary supplements. Dr. Jonas believes the move reflects a broader dissatisfaction in Washington with the current regulatory systems. Many of their concerns are legitimate.
“We need to pay attention to the drivers of this (the McCain bill), among them the issues of quality, safety, science or lack thereof, issues of how claims are made.” He and others at the IHS echoed Congress’ worries about, among other things, the presence of drugs in sports supplements, low-quality raw materials in the supply stream, witting or unwitting false labeling, exaggerated claims, borrowed science, and product inconsistency.
The Empire Strikes Back?
Concerns about adverse effects may be overstated, at least according to the first wave of data to emerge since a 2007 federal mandate requiring supplement companies to report serious adverse events to the FDA. In 2008, the agency received just 1,025 reports of major supplement-associated side effects. At a time when properly used pharmaceuticals are thought to cause between 300,000 and 500,000 deaths per year, and major US drug production plants are being shut down for shoddy manufacture, that doesn’t sound too bad.
Mark Hyman, MD, one of the country’s best known integrative physicians and author of several popular books including the best-selling, UltraMind and UltraMetabolism series, agreed that there are some reasonable concerns about supplement quality. But he believes the McCain-Dorgan proposal, had it passed, would have inappropriately restricted access to useful products, and obstructed the further evolution of integrative medicine.
“Calling it a ‘Safety Act’ is a joke. It is a pharmaceutical industry-driven initiative,” said Dr. Hyman, who saw a much more restrictive agenda hidden beneath the generally reasonable public health wording of the bill.
Drs. Hyman and Jonas both agreed that, rightly or wrongly motivated, there are a lot of lawmakers and medical opinion leaders who have serious concerns about the quality of nutritional products.
Waxman’s Hidden Axe
In May, barely two months after Sens. McCain and Dorgan backed off, alarm bells rang loudly inside the echo-chamber that is the “Health Freedom” blogosphere: Congressman Henry Waxman (D-CA), had launched a “sneak attack” on the supplement industry by surreptitiously introducing language into the Wall Street Reform bill that would give the Federal Trade Commission (FTC) unprecedented power to squash supplement companies.
At issue is Section 4901 of the Wall Street Reform & Consumer Protection Act of 2009 (HR 4173), a cryptic set of proposed changes to the US Code that would, if implemented, expand the FTC’s ability to make new rules independent of congressional or judicial oversight. The proposal says nothing specific about dietary supplements, holistic medicine or anything that signals a direct threat. But Washington insiders say if you know how to decode the legalese, the message spells trouble.
“If you plug in all the proposed changes (into the US Code), you see that this would….delete a series of safeguards in place since the 1980s that kept the FTC from over-reaching its authority,” said Gretchen DuBeau, executive and legal director for the Alliance for Natural Health USA, a public advocacy group. “FTC is supposed to regulate advertisements and marketing only, not substantive areas. This new language would give the FTC basic rule-making authority.”
Supplement industry advocates fear that if enacted, the new legislation would permit the FTC to step beyond its current role of policing marketing claims according to existing standards established by the FDA, and into the role of setting new standards and requirements about what claims are permissible.
Ms. DuBeau said the US Chamber of Commerce initially detected the potential threat hidden in Section 4901. Expanded FTC rule-making power could potentially affect dozens of industries, and she acknowledged that there’s nothing in any of this language specific to dietary supplements. But it’s Section 4901’s author—Rep. Waxman—that has her organization worried.
“Rep. Waxman is a longstanding critic of the supplement industry. He has said that DSHEA (the Dietary Supplement Health & Education Act of 1994, which enabled supplement companies to advertise structure-function claims) is one of the worst mistakes Congress ever made. He knows this industry has grassroots support, and after what happened with McCain-Dorgan, he knows he can’t take direct action. But he could do something covert. If you connect the dots, you can see that this could set the stage for much more restrictive regulation.”
The Wall Street Reform bill passed the House and is pending in the Senate. The Alliance for Natural Health and other health freedom and free-market advocacy groups are pushing to have Waxman’s proposals struck from the bill during Senate hearings.
Paul-itical Science
The dietary supplement industry does have its champions inside the Beltway, among them Congressman Ron Paul (R-TX). The former physician, outspoken “constitutionalist,” and enemy of income taxes, is strongly supportive of integrative/preventive medicine.
Last year, Rep. Paul introduced the Freedom of Health Speech Act (HR 3394) which would prohibit the Federal Trade Commission from classifying any information as “advertising” (and therefore under FTC jurisdiction) unless it is specifically intended by a product seller “to promote that product’s sale, and the content includes the name of the product, an express offer to sell, and a purchase price.” It would prohibit FTC from treating scientific content of peer-reviewed journals as “advertising” and potentially subject to its jurisdiction.
Further, the bill would block investigation of possible false advertising “unless the FTC already possesses clear and convincing evidence that the advertisement is false and misleading.” Rep. Paul’s aim is to place the burden of proof on FTC to show that a supplement ad is false. Under existing rules, a company accused of false advertising must prove that its claims can be substantiated, a sort of “guilty until proven innocent” approach.
Similarly, Rep. Paul’s Health Freedom Act (HR 3395) would eliminate the FDA’s existing power of ‘prior restraint’ on language about nutrient-disease relationships. Currently, it is illegal for product manufacturers to describe the connection between nutrients (or nutrient deficiencies) and specific disease states, unless they can “clearly and convincingly” prove those relationships to the FDA. In Rep. Paul’s world, the roles would be reversed, and FDA would be obliged to prove—clearly and convincingly—that a particular claim was false.
The third element in Paul’s health freedom trifecta is the Congressional Responsibility and Accountability Act (HR 3396) that would prohibit the FDA, FTC, or any other non-elected federal agency from creating or enacting any new regulations without their first being passed by Congress, “in concordance with Article I of the Constitution.”
Rep. Paul’s bills have not gone very far. The Congressional Responsibility & Accountability Act has been referred to the House subcommittee on Commercial and Administrative Law. His other two bills have been stalled since last summer in the House Committee on Energy and Commerce, headed by—you guessed it—-Rep. Henry Waxman!
The battles over regulation of dietary supplements and integrative health care are likely to rage back and forth for years to come. Given their potential impact on clinical practice, they’re worth keeping your eye on.
