Regulating the Supplements Industry

A  Mother Jones article some months ago explored an increasingly pertinent topic: the regulation of supplements and complementary drugs that have largely been devoid of oversight. This is an important issue given the rapid growth of the industry, which is estimated to be worth around $20 billion as of last year (the data seem to vary by source, but that’s the most common figure I’ve found).

It all begins with St. John’s Wort, an herbal remedy that’s been shown to treat mild and moderate depression to some extent, but is otherwise not a viable cure for such things, as is often believed or advertized. By the far most popular supplement on the market, Americans spend around $55 million on it annually, purchasing it mostly from large retailers likes GNC, Whole Foods, and the Vitamin Shoppe.

But SJW has been found to produce adverse affects with other medications, including antidepressants. While these kinds of drugs are legally required to undergo clinical trials, regulatory approval, and labeling, supplements are exempted:

The real problem here lies in transparency to consumers—a problem that goes directly back to the supplement’s manufacturers. In a 2008 study published in BMC Complementary and Alternative Medicine that tested 74 different SJW brands, less than a quarter of the product labels identified possible interactions with antidepressants. Even more disturbing was that only 8 percent identified possible interactions with birth control.

Many groups, like the Center for Science in the Public Interest, have tried to push the FDA to standardize SJW labels to properly reflect possible dangers. But since supplement makers are not required by law to warn consumers about health risks associated with their products, it hasn’t been easy. “These companies fight warning labels like the dickens, and whether they intend it or not, that affirms the belief that natural products are unequivocally good for you,” says Stephen Gardner, litigation director at CSPI.

It’s a common fallacy among many people that what is natural is therefore better and, conversely, what is synthetic is undesirable. This ignores the fact that nature is full of toxic things, while some artificial medicines – which are often derivative of organic substances – are demonstrably safe and effective (compare the prevalence of disease nowadays to what it was decades ago – both the variety of illnesses and their severity have gone done markedly).

Proposed cures and treatments, regardless of their origin, should be judged in a case-by-case basis. Their merit derives from their ethics, safety, and efficacy, not whether or not they’re traditional, natural, or made in a laboratory. Such origins are irrelevant as to their effectiveness, which is why we have experiments, clinical trials, and peer review.

So why don’t federal regulators force the supplement industry to include warning labels on their products? One big reason is that the industry has powerful allies in Washington. The current murky regulatory force in the supplement world is the Dietary Supplement Health and Education Act (DSHEA), which lets supplements fly to the shelves without first having to demonstrate either safety or effectiveness to the FDA. Unlike prescription meds, the burden of proof for supplements resides with the federal government: The FDA has to prove that products are unsafeafter the fact, rather than manufacturers having to prove that they are safe for use in the first place. (Think back to weight-loss supplementephedra, which took the FDA more than seven years to ban—despite being conclusively tied to heart attack, stroke, and death.)

Many have taken issue with the DSHEA, and in February 2010 Sen. John McCain (R-Ariz.) introduced a bill that would increase regulation of dietary supplements that might pose health risks. Enter Sen. Orrin Hatch (R-Utah), who has received upwards of $888,000 in campaign contributions from the health product industry since 2002. Hatch, one of the lead authors of the 1994 DSHEA, has even stronger ties than that—both his son and five former aides are lobbyists in Washington representing the very industry funneling him all that campaign cash. It shouldn’t come as too much of a surprise then that shortly after McCain’s bill proposal, Hatch met with the Arizona senator for some “real talk” on supplement regulation. In a letter released after their private meeting, Hatch thanked McCain for withdrawing his support for parts of the bill that “would do great harm to the dietary supplement industry.” A castrated version of the bill eventually made it through, and the supplement industry came out unscathed.

There’s no doubt that the pharmaceutical and medical lobbies can be just as conniving as any other special-interest group. Drug makers and doctors are just as liable to be mistaken or immoral as anyone else. The profit motive erodes efforts to find certain cures or manufacture certain drugs. The system clearly has its problems.

However, we’re only kidding ourselves if we think alternative medicine proponents are any more incorruptible and honest. There’s no doubt that many of them are sincere and well-meaning, and that they have some understandable qualms about the modern healthcare industry (as do a lot of doctors).

But humans are keen to exploit any money-making trend that they can, and the supplement industry is no exception: it has the same selfish and dishonest reasons to peddle it’s own cures as big pharma does, given how many people are uncritically shelling out billions for its wares.

Last year, Sen. Dick Durbin (D-Ill) introduced a new bill requiring that supplements that could cause health problems or interact with other drugs—like St. John’s wort—display mandatory warning labels on their products. The bill has not yet been up for a vote, but the industry has already riled up huge opposition—headed, you guessed it, by Hatch himself. The main argument, it seems, is going to hinge on the necessity of labeling products derived from natural sources.

“Supplements are largely based on food and widely considered to be safe, so they don’t need to be labeled,” says Mike Greene, vice president of government affairs at the Council for Responsible Nutrition, the industry’s largest trade group. “For example, you don’t see anyone labeling grapefruit, even though it interacts with Lipitor.”

Whether or not the Durbin bill will make it through the Senate remains to be seen. In the meantime, though, Gardner takes issue with Greene’s argument. “You don’t see people selling grapefruits as cancer cures,” he says. “Look, we’re not interested in stopping people from buying SJW if they know what they’re getting. But we are interested in stopping them if they’re in the dark about it. These companies have prevented people from knowing when they should question them. That’s not logic and that’s not fair.”

So what do you guys think – should government regulate this industry, and does it even have an obligation to in the first place? Or is this best left up to consumers to figure out for themselves?