You may not know it, but nutritional supplements are not regulated by the Food and Drug Administration (FDA) in the United States. While the FDA takes action against battered or inferior supplements after they have come onto the market, the companies that manufacture and sell those products are ultimately responsible for ensuring that they are labeled securely and correctly before they reach the market
This is the system that has been in operation for over two decades under the 1
"We announce a new plan for policy advancement aimed at introducing one of the most significant modernizations of nutritional supplement regulation and monitoring in more than 25 years", dr. Gottlieb said in the statement released on Monday. "We know that most of the players in this industry act responsibly. However, bad actors have the opportunity to use the halo created by the quality work of legitimate manufacturers to instead sell and sell dangerous products that endanger consumers. "
Dr. Gottlieb pointed out that over the last 25 years since DSHEA's adoption, the number of supplements has risen from $ 4 billion to $ 40 billion. And as they become more popular, "so does the number of companies that market potentially dangerous products or make unproven or misleading statements about the health benefits they may bring."
Here's what the FDA suggests.
The FDA wants to create a new policy to ensure that consumers receive "safe, well-made and labeled products," Dr. Gottlieb.
"One of my ultimate goals is to strike the right balance between consumer conservation." Access to lawful supplements, while at the same time fulfilling our solemn commitment to protect the public from unsafe and unlawful products, and bringing to justice those who are unable or unwilling to comply with the requirements of the law, "he said ,
The FDA wants to communicate faster with the public if it has concerns that an ingredient is potentially dangerous and should not be included in supplements. That's why the agency, like Dr. Gottlieb said, "a new tool for rapid reaction to the public", so you must avoid the purchase or use of products containing this ingredient.
In addition, the agency is working to ensure this. "Your framework is flexible enough to evaluate product safety while enabling innovation," Dr. Gottlieb. They also plan to do more collaborative research to evaluate and better understand products, and act against shady statements, such as when a company makes unsubstantiated claims that a product is used, for example, to combat diabetes and will contribute] cancer . (Dr. Gottlieb points out that the FDA has sent so-called warning letters to 17 companies manufacturing products that they claim to treat or cure Alzheimer's disease .)
Finally, Dr. Gottlieb The FDA wants to talk with people about whether steps to modernize DSHEA are needed.
Experts say this is a good thing, even if the details are vague at the moment.
"This is a great development," Timothy Caulfield, research director at the University of Alberta's Health Law Institute, told SELF. "Supplements are a multi-billion dollar industry that is not well regulated. Studies have shown that the quality control is lacking and that some supplements may be harmful, including causing adverse reactions . "
With the way things were, people are so used to guinea pigs," explains William J. McCarthy, Professor of Health Policy and Management at UCLA's Fielding School of Public Health, to SELF. "If you had a product in the past, you just spent it, and as long as it did not hurt people, it was alright," he says. "The FDA could not take action until there were signs of harm, and that's clearly not good."
As for the supplements that target cancer patients, it is "outrageous" that these allegations are made, Jack Jacoub, MD, a medical oncologist and medical director of the MemorialCare Cancer Institute at Orange Coast Medical Center, Fountain Valley, California , opposite to SELF. "There is no evidence to support the claims that they are a fundamental problem," he says. "If you are in vulnerable state and are mentally vulnerable, these claims sometimes offer unrealistic hope." As a result, he says, "Any kind of supervision and regulation is welcome."
But Liz Weinandy, a registered dietitian at Ohio State University's Wexner Medical Center, tells SELF that she has "mixed feelings," according to the FDA. "Right now, anyone in a garage can make additions and sell to the public, and that's not a good thing," she says. "But my biggest concern is that this is not a detailed plan." Weinandy is also concerned that major supplements manufacturers may have too much influence on the creation of the new regulations and "strangle smaller, responsible supplements."
Even if this is possible, McCarthy fears that a stronger review process used by the pharmaceutical industry may grant some companies exclusive rights to sell a supplement for a certain period of time – and this may increase prices.
Overall, "it's good news," says Sonya Angelone, MS, RDN, a spokeswoman for the Academy of Nutrition and Dietetics, to SELF, but she's worried that this is all in the air. "My concern is that they need much more resources to achieve this as they already have backlog with insufficient staff to oversee food, medicines and supplements," she says.
All in all, the experts hope that this is the case. This would make the nutritional supplement industry a little safer.
You should consult your doctor before taking any supplements.
After all, you do not even need one – and Caulfield says he hopes FDA will appeal as well. "Despite the popularity of dietary supplements, available science suggests most are largely unusable ," he says, adding that they only produce "expensive pee". Others may interact with medications or cause unexpected side effects.
DR. Gottlieb says that over the next few months and even years, the FDA will continue to make efforts to improve regulations in the complementary industry. "The steps outlined today show where we are right now and what we are looking forward to," he says in the statement. "We are committed to continuing our work with both our industry partners and nutritional supplements and will announce further ideas that we intend to bring to market in the near future."