Somewhere on almost every bottle of vitamin C or echinacea is the sentence: “This statement has not been evaluated by the FDA. This product is not intended to diagnose, treat, cure, or prevent any disease.” Unlike pharmaceutical drugs, which require extensive FDA testing and years of bureaucratic hurdles before they can be put on the market, supplements can be sold with little to no FDA input. This lack of regulation is often criticized for allowing ineffective supplements to be marketed under the guise of medicine, which is the motivation for legally required statements like the one above. The debate over the FDA’s regulation of supplements has always been framed as an issue of their effectiveness in treating the ailments they claim to address. A new case from the New York Attorney General’s office, however, poses a different set of issues: Are supplements not only ineffective but also dangerous?
The New York Attorney General’s office has sent cease-and-desist letters to major supplement retailers—including Target, Walmart and GNC—after a study showed their products very rarely contained the advertised ingredients. Walmart was the worst offender, with only 4 percent of its products containing what was on the label. Overall, only one in five of the tested supplements contained traces of their purported ingredients. The depression-fighting pill St. John’s Wort, for instance, contained no trace of the herb but rather rice, garlic and a tropical houseplant. These results were even more concerning because many of the products contained known allergens, which were not included on the labels. The retailers have agreed to pull the products from their shelves, although they contest the accuracy of the tests, which, they contend, are not in line with established FDA procedures, a curious claim given the reluctance of the FDA to insert itself into the fray.
This controversy raises a larger question: Why isn’t the FDA involved? The manufacturers object to the Attorney General’s case on somewhat surprising grounds: If the products are truly mislabeled and dangerous, the FDA should be punishing them, not the Attorney General. But FDA regulations raise a whole host of issues themselves. One problem with current FDA procedures, which the Attorney General’s office is attempting to improve, is that there is no method for routine testing to ensure that supplements aren’t being fraudulently marketed. The FDA has emphasized that it does not test the supplements before they are sold to the public and that the manufacturer is responsible for ensuring that the products are safe and correctly labeled. There are no random tests before or after the products are sold. The FDA argues that, with its limited funding, “it focuses [its] resources first on public health emergencies and products that may have caused injury or illness.”
The problem with this strategy is that supplements are often used like medicine. Supplement manufacturers argue that the comparison to medicine is unfair because their products are more similar to food, which has comparably lax regulatory procedures. Yet the nature of supplements means that they are used on a vulnerable population: the sick. In October, for example, a premature infant died after being administered a probiotic supplement by nurses in a neonatal intensive care unit. The CDC discovered that the probiotic had been contaminated with a deadly fungus during the manufacturing process. Despite FDA warnings that the products are unapproved, doctors often use probiotics to prevent premature infants from getting inflammatory bowel disease. In regards to this practice, the American Gastroenterological Association warns, “[Probiotics] are not standardized, meaning they are made in different ways by different companies and have different additives. How well a probiotic works may differ from brand to brand and even from batch to batch within the same brand.” While the probiotics used on the infant were recalled, critics have pointed out that the death could’ve been prevented if the FDA standardized probiotic production and tightened their regulatory procedures.
Yet, regulating supplements like medicine may not be the solution. Stricter regulations would severely limit consumer choice in the face of increased demand for alternative medicine. The United States is pushing back against the perceived corruption of big pharmaceutical companies; anti-vaccination movements are gaining traction, and the demand for alternative medicine has multiplied several times over. Despite the safety issue of supplements, regulating them like medicine would harm consumers, who want alternatives to the drugs produced by the massive pharmaceutical industry. Even so, the safety of supplements is still an issue—to re-think supplement regulation, we need to consider the regulatory process itself.
In the current system, supplements are regulated minimally, without a focus on either safety or efficacy. Medicine is regulated for both safety—to prevent incidents of contamination like the case of the fungus-ridden probiotics—and efficacy. Supplement regulation would limit consumer choice because, despite consumer claims, there isn’t an extensive body of evidence proving they work, and so the FDA would not approve them. Yet preventing fraudulent sales and deaths from supplement contamination is an issue of safety. Supplements should be regulated solely in this regard.
The FDA’s focus on both efficacy and safety began as a response to the thalidomide birth defects crisis, in which thousands of children were born with severe birth defects after their mothers were given the medication thalidomide during their pregnancies. The case was a clear-cut issue of product safety, but after the crisis, stricter FDA regulations were put in place. The Kefauver Harris Amendment, adopted in 1962, required that new drugs be tested not only for safety, but also for efficacy. This process has been criticized for slowing down the drug regulation process and preventing possibly helpful drugs from being put on the market. Before the amendment, new drugs took an average of seven months to be approved. After the amendment, that time increased to 7.3 years. This delay was particularly controversial during the AIDS crisis, when, critics argued, over-regulation cost people their lives. The FDA has since expedited the approval process for treatments of life-threatening conditions, but, for other medications, the process is still slow and, some say, unnecessary. The safety of medicine should be ensured, but the free market can determine its efficacy, as it did before 1962. The FDA points to its limited resources as the reason for supplement under-regulation, yet those same resources are being used to over-regulate medicine.
Overhauling the FDA’s regulatory procedures is a massive goal and could be one solution to the consumer demand for safe, alternative medicines. In the meantime, supplement safety still needs to be ensured. The Attorney General’s approach could fill the void left by the FDA. This case against supplement retailers is the first of its kind. Usually after receiving a complaint, the FDA would warn the retailers that their supplements are mislabeled and would allow them the chance to take them off the shelves. But the FDA doesn’t usually receive complaints about product mislabeling—the complicated tests done by the Attorney General’s office aren’t easily accessible. This case marks the first time that a body independent of the FDA has stepped in to pre-emptively regulate the supplement industry before any complaints are filed.
This step might offer a solution to the problem of supplement regulation. Allowing the products to be tested by independent bodies, and then punishing companies that are found to be fraudulent rather than simply warning them, could give greater incentive to correctly market products, while sparing the FDA’s resources.