You may not realize it, but dietary supplements aren’t regulated in the U.S. by the Food and Drug Administration (FDA) the same way that medications are. And, while the FDA will take action against misbranded or inferior supplements after they hit the market, the companies that make and sell these products are ultimately responsible for making sure they’re safe and correctly labeled before they’re available for you to buy.
That’s the system that’s been in place for over two decades under the Dietary Supplement Health and Education Act (DSHEA) of 1994. Now, FDA commissioner Scott Gottlieb, M.D., announced in a statement that the organization wants to consider imposing tighter regulations.
“We are announcing a new plan for policy advancements with the goal of implementing one of the most significant modernizations of dietary supplement regulation and oversight in more than 25 years,” Dr. Gottlieb said in the statement, released Monday. “We know that most players in this industry act responsibly. But there are opportunities for bad actors to exploit the halo created by quality work of legitimate manufacturers to instead distribute and sell dangerous products that put consumers at risk.”
Dr. Gottlieb pointed out that supplements have grown from a $ 4 billion to $ 40 billion industry in the last 25 years since the DSHEA was passed. And, as they’ve become more popular, “so have the number of entities marketing potentially dangerous products or making unproven or misleading claims about the health benefits they may deliver.”
Here's what the FDA is proposing.
The FDA wants to create new policy to make sure consumers get "safe, well-manufactured, and appropriately labeled products," Dr. Gottlieb said.
“One of my top goals is ensuring that we achieve the right balance between preserving consumers’ access to lawful supplements, while still upholding our solemn obligation to protect the public from unsafe and unlawful products, and holding accountable those actors who are unable or unwilling to comply with the requirements of the law,” he explained.
The FDA also wants to communicate to the public more quickly when they have concerns that an ingredient is potentially dangerous and shouldn’t be in supplements. That’s why the agency is developing a “new rapid-response tool to alert the public,” as Dr. Gottlieb said, so you can avoid buying or using products with that ingredient.
In addition, the agency is working to make sure that their framework is flexible enough for them to evaluate product safety while allowing for innovation, Dr. Gottlieb explained. They also plan to do more collaborative research to evaluate and better understand products and to take more action against shady statements, such as when a company makes unsubstantiated claims that a product will, say, help fight diabetes and cancer. (Dr. Gottlieb points out that the FDA just sent warning letters to 17 companies that manufacture products they claim will treat or cure Alzheimer’s disease.)
Finally, Dr. Gottlieb said the FDA wants to talk to people about whether steps to modernize the DSHEA are necessary.
Experts say this is a good thing, though the details are a little vague right now.
“This is a terrific development,” Timothy Caulfield, research director at the Health Law Institute at the University of Alberta, tells SELF. “Supplements are a multi-billion dollar industry that is not well regulated. Studies have shown that quality control is lacking and that some supplements can be harmful, including causing adverse reactions.”
With the way things have been, “humans are being used as guinea pigs,” William J. McCarthy, Ph.D., adjunct professor of health policy and management at the UCLA Fielding School of Public Health, tells SELF. “In the past, if you had a product, you just put it out and as long as it didn’t harm people, it was fine,” he says. “The FDA couldn't take action until there was already evidence of harm, and that’s clearly not good.”
As for the supplements that target people with cancer, it’s “outlandish” that these claims are being made, Jack Jacoub, M.D., a medical oncologist and medical director of MemorialCare Cancer Institute at Orange Coast Medical Center in Fountain Valley, Calif., tells SELF. “There’s no evidence behind the claims that they’re making, which is a fundamental problem,” he says. “If you’re in a vulnerable state of health and vulnerable mentally as a consequence, sometimes these claims offer a hope that’s unrealistic.” As a result, he says, “any kind of oversight and regulation is welcome.”
But Liz Weinandy, a registered dietitian at The Ohio State University Wexner Medical Center, tells SELF that she has “mixed feelings” on the FDA's statement. “Right now, anyone can make supplements in a garage and sell it to the public, and that’s not a good thing” she says. “But my main concern is that this isn’t a detailed plan.” Weinandy says she’s also worried that larger supplement manufacturers may have too much of a say in creating the new regulations and “strangle smaller, responsible supplement makers in the process.”
Even if it is achievable, McCarthy is concerned that going to more of a vetting process that's used by the pharmaceutical industry could allow some companies to have exclusive rights to sell a supplement for a period of time—and that can raise prices.
Overall, “it is good news,” Sonya Angelone, M.S., R.D.N., a spokesperson for the Academy of Nutrition and Dietetics, tells SELF, but she’s worried that this is all talk right now. “My concern is that they will need many more resources to accomplish this since they already have a backlog of work with not enough staff to oversee food, drugs, and supplements,” she says.
As a whole, experts are hopeful that this will make the supplement industry a little safer.
You should still check in with your doctor before taking any supplement, Weinandy says.
After all, you many not even need one—and Caulfield says that’s something he hopes the FDA will address as well. “Despite the popularity of supplements, the available science suggests most are largely useless,” he says, adding that they just create “expensive pee.” Others may interact with medications or cause unexpected side effects.
Dr. Gottlieb says that the FDA is planning to roll out more efforts in the next few months and even years to improve the regulations in the supplement industry. "The steps outlined today highlight both where we are currently and where we look forward to moving toward," he says in the statement. "We are eager to continue our work with both our industry partners and dietary supplement consumers and will announce more upcoming ideas that we hope to roll out in the near future."