JAMA Commentary Calls for More Supplement Regs

HOUSTONFDA's limited authority to regulate dietary supplements has led to consumers spending tens of billions of dollars annually on ineffective and potentially dangerous products, according to a new commentary from Donald M. Marcus, M.D., Baylor College of Medicine, Houston; and Arthur P. Grollman, M.D., Stony Brook University, Stony Brook, NY (Arch Intern Med. 2012;172(13):1035-1036. DOI:10.1001/archinternmed.2012.2687). The commentary was published in the Achieves on Internal Medicine, a publication for health care providers.

Attack on DSHEA

The authors urged health care professions to lobby Congress to revise the Dietary Supplement Health and Education Act of 1994 (DSHEA). They said FDA needs "the authority required to effectively regulate dietary supplements," adding, "FDA should have authority to mandate immediate withdrawal of dangerous supplements from the market. In addition, Congress should provide FDA with the personnel and resources needed to protect the public."

Duffy MacKay, N.D., vice president, scientific and regulatory affairs at the Council for Responsible Nutrition (CRN), said the authors are misguided in their thinking that more regulation is the answer. "Even if the authors got 100 percent of their wishes, and there was a drug-like premarket approval process for supplements, there would still be outliers engaging in illegal activity. But the vast majority of the dietary supplement industry is following the law and making valuable products for consumers."

Marcus and Grollman blamed DSHEA  for FDA's lack of oversight. "Even when the agency identifies an unsafe product, it lacks authority to mandate its removal from the market because it must meet the very high legal requirement to demonstrate 'significant or unreasonable' risk," they wrote, noting this is why it took FDA more than 10 years to remove ephedra from the market.

MacKay countered by saying FDA has more then ample authority to regulate the supplement industry. "FDA has mandatory recall authority,  and it has authority to withdrawal products it thinks are dangerous," he said.

Cara Welch, Ph.D., senior vice president of scientific and regulatory, Natural Products Association (NPA), also said the commentary gets it wrong about dietary supplement regulation. "Weve said it before and well say it again. FDA has all the authority it needs to regulate supplements under DSHEA. And the FDA agrees. Their officials have testified before Congress that they have all the tools they need to effectively regulate supplements.

Welch reminded that FDA regulates safety, manufacturing and labeling of supplements, while FTC regulates supplement advertising. "FDA and FTC have the authority to regulate company websites and take action against companies that step out of line. Instead of more regulations, NPA believes the supplement industry needs enforcement of existing regulations. We have time and again called on Congress to provide the resources needed to fully enforce the law.

NDI Draft Guidance Support

The commentary authors urged internists to also support FDA's new dietary ingredient (NDI) draft guidance, which industry said goes beyond the intent DSHEA. FDA has since agreed to reissue this draft guidance.

While Mackay said it's too late to support the first NDI draft guidance because FDA has agreed to redo it, it's a policy-orientated discussion that many clinicians don't understand. "If physicians were to read it and understand it, then absolutely, they should jump on board and have seat at the table."

However, he said if health care providers read and understood that FDA believes every processing change would trigger an NDI, they may not support it. "If they saw that when a company changes the way it makes vitamin C, it will have to go through this expensive process that would raise the price so patients can't afford it, they might not think vitamin C needs that much regulation.

Supplement Education

Marcus and Grollman also said health care providers are misinformed on supplements. This is because the education they receive about dietary supplements is provided by advocates of complementary and alternative medicine who often minimize the adverse side effects.

MacKay disagreed. He said the limited education in the medical curriculum about nutrition is mostly elective based. "In those situations, advocates become teachers, but they are also the experts," he said. "I've been through many trainings where teacher were cautionary and responsible. They aren't making money off these products. Maybe they think [the supplements] work, but it's not like they are biased in a way that will make them go out on a limb. I feel academic curriculum tends to be balance." MacKay added that other parts of the education, such as pharmacology and pharmacist training, offers training on drug-nutrient interactions and side effects. 

DMAA

The commenatry authors also called out an article by Pieter A. Cohen, M.D., that discusses supplements that contain  1,3-dimethylamylamine (DMAA), which Cohen called an amphetamine derivative (Arch Intern Med. 2012;172(13):1038-1039. DOI:10.1001/archinternmed.2012.1677). Cohen said DMAA remains on the market because of a loophole in the regulations. DMAA marketers claim the ingredient is derived from the botanical geranium, but he said that is based on a single flawed study.

DMAA is a controversial ingredient whose legality has been questioned by FDA via warning letters. It has also been the root of numerous class actions lawsuits, bans and government warnings.

Marketing and Adulteration

In addition, Marcus and Grollman said a GAO report noted supplement labeling is often inadequate and that consumers are poorly informed about their regulations. A second GAO report cited by the authors  found websites frequently made unsound and illegal claims that a dietary supplement cured or prevented diseases. That GAO report also noted investigators posing as customers were informed by sales staff at retail outlets that they could take supplements instead of prescription medicines.

Then, the authors noted FDA commissioner Margaret Hamburg's December 2010 warning to the industry about adulteration in sports nutrition, weight management and sexual health products.

NPA does share the concern about adulterated products," Welch said. "These illegal products are not supplements, and we support continued government efforts to crack down on those who make illegal drugs marketed as supplements."

No Benefits

With all these adulteration issues, the authors noted research has not shown benefits of dietary supplements. "Rigorous controlled trials of popular herbals supported by the National Institutes of Health (NIH) and other independent sources of funding have found most botanical supplements to be ineffective."

MacKay said this is an irresponsible overgeneralization. "If you go to NIH's website, there is a balanced discussion of benefits and what people can expect," he said.

Greater Implications

MacKay said the big risk with misguided articles like this is that physicians will consider all supplements dangerous and then tell their patients to avoid them. "We're concerned that commentaries like this will cause doctors to dismiss supplements as a lump sum category," he said. "That causes patients to become less likely to tell their doctors what they are taking." He said if a doctor rejects the positive effects of supplements a patient has experienced,  that patient will be less likely to use their doctor as a ally in their health care. This is a situation no one wants, MacKay said.

Welch said the commentary "May needlessly scare people into not taking products they use to support their health. Its been long established that supplements provide nutrients we sometimes miss in our regular diet." Welch also noted NPA  advises Americans to discuss supplement usage with their health care provider.