Are supplements regulated?
The FDA defines a supplement as any product "intended to add further nutritional value to (supplement) the diet."
Survey results show that over half of all Americans report taking at least one supplement per day. In fact, today’s supplement industry is estimated at a worth of over $37 billion a year.
The FDA regulates both dietary supplements and their ingredients. However, the regulations governing the supplement industry are different than those governing the “conventional” food and drug industries.
In 1994, Congress passed the Dietary Supplement Health and Education Act (DSHEA), which granted the FDA authority to establish regulations regarding dietary supplement manufacturing, regulating health claims and labeling of dietary supplements.
- “Manufacturers and distributors of dietary supplements and dietary ingredients are prohibited from marketing products that are adulterated or misbranded.” This means the manufacturing firms are responsible for evaluating the safety and labeling of their own products before marketing. And the manufacturers, themselves, must make sure their products meet all the requirements of DSHEA and FDA regulations.
- The FDA is responsible for taking action against any adulterated or misbranded dietary supplement product after it reaches the market.
In summary, dietary supplements do not need approval from the FDA before they are marketed to the public.
Concerns over the FDA’s Regulation
In 1994, when DSHEA was passed, about 600 supplement companies were producing about 4,000 products for total revenue of about $4 billion.
Since then, the market has exploded. Today, close to 6,000 companies manufacture about 75,000 products.
And according to Steven Tave, the director of the office of dietary supplement programs at the FDA, 26 people and a $5 million budget are regulating that whole market.
This lack of resources is one of the main issues with FDA regulation. Even though the FDA states on their own website that they regulate “both finished dietary supplement products and dietary ingredients,” the frequency of which they analyze the content of dietary supplements is cause for concern.
In fact, they admit openly that “The FDA has limited resources to analyze the composition of food products, including dietary supplements, it focuses these resources first on public health emergencies and products that may have caused injury or illness.”
And speaking of injury or illness, an article in the The New England Journal of Medicine estimated that there are about 23,000 emergency department visits per year related to adverse effects from dietary supplements.
Among these emergency visits, those related to weight-loss or energy products were the most frequent.
There’s no doubt the problem is getting worse as the industry grows. Between 2000 and 2012, the annual rate of negative reactions to supplements rose from 3.5 to 9.3 cases per 100,000 people, a 166% increase.
Manufacturers are required to submit all serious adverse events associated with use of their dietary supplements to the FDA. But there is speculation as to whether they are reporting these adverse effects, as they should be. Or even worse, do the manufacturers already know about the adverse effects of these products and sell them anyway?
After all, most unsafe supplements have been found to contain ingredients that aren't listed on their labels.
And a study published by the Journal of the American Medical Association in 2013 found that of the 274 supplements recalled by the FDA between 2009 and 2012, all contained banned drugs.
What’s worse…a 2014 report found that of all the supplements purchased 6 months after recall, more than two-thirds of them still contained banned drugs.
It’s clear there is an obvious problem here.
That being said, this post is not to say that all dietary and nutritional supplements are bad for you. However, it’s important to know that while the supplement industry is technically regulated, you should exercise caution when buying into these claims.
Brodwin, Erin. “The $37 Billion Supplement Industry Is Barely Regulated - and It's Allowing Dangerous Products to Slip through the Cracks.” Business Insider, Business Insider, 8 Nov. 2017, www.businessinsider.com/supplements-vitamins-bad-or-good-health-2017-8.
Center for Food Safety and Applied Nutrition. “Dietary Supplements.” U S Food and Drug Administration Home Page, Center for Food Safety and Applied Nutrition, www.fda.gov/Food/DietarySupplements/.
FACS, Sharon T McLaughlin MD. “Should the Supplement Industry Have Stronger Regulation?” The Huffington Post, TheHuffingtonPost.com, 25 Nov. 2015, www.huffingtonpost.com/sharon-t-mclaughlin-md-facs/should-the-supplement-industry-have-stronger-regulation_b_8634362.html.
Regulation of Dietary Supplements, www.chpa.org/RegulationDS.aspx.