Dietary supplements: safe or shenanigans?
If you’re one of the many millions of Americans taking dietary supplements, either daily or every so often, you no doubt expect them to be safe, and to contain what they say they do. In this case it would also no doubt be a huge disappointment to learn the supplement industry is basically not regulated by anyone, and that you can’t really be sure of the contents of your supplements.
In 1994 the supplement industry lobbied hard to pass the Dietary Supplement Health and Education Act (DSHEA) to ensure that the FDA has practically no power in regulating dietary supplements. The main points of the act are: “Manufacturers and distributors of dietary supplements and dietary ingredients are prohibited from marketing products that are adulterated or misbranded. That means that these firms are responsible for evaluating the safety and labeling of their products before marketing to ensure that they meet all the requirements of DSHEA and FDA regulations.” And “FDA is responsible for taking action against any adulterated or misbranded dietary supplement product after it reaches the market.”
So in short, the supplement manufacturers are not responsible to demonstrating the safety or efficacy of their products to the FDA prior to going to market. They are only responsible for evaluating the safety of their own products, which can be done however they please. If you were responsible for evaluating your own product against no set rules or regulations, with no immediate consequences even if your product turned out to be harmful, would you use extensive and expensive clinical trials or laboratory tests to ensure the safety of the product? Or would you maybe hand it out to a few folks and see what happens? And if nothing is visibly going awry it must be safe and ready to hit the market!
The FDA is only able to take action after the product is on the market. Note that “take action” does not mean the FDA has the power to immediately recall or prohibit sales of misbranded products, even if the product turned out to be 100% misbranded, flour instead of collagen, for example.
The product cannot even be immediately recalled if a person dies from a supplement.
In her book What to Eat, Marion Nestle puts it like this: “Congress passed DSHEA in 1994 on two quite questionable assumptions: that supplements are basically harmless, and that supplement makers are honest.” These assumptions turned out to be lethal in the case of ephedra. Ephedra is an herb used in supplements for weight-loss and increased sports performance. It took the FDA about a decade’s worth of ephedra related deaths and illnesses to be able to prove the supplement is truly dangerous, and to subsequently ban it in 2004.
If you’re reading this with a furrowed brow and worry over the safety of the supplements you’re taking, you can see how they rank on Labdoor, an independent company that tests supplements for label accuracy, product purity, nutritional value, ingredient safety, and project efficacy. For example, you can compare which brand of probiotics has the most viable bacteria- most of them have far less than they proclaim.
In light of the consumer confusion over supplement safety, CVS has also launched their own “Tested to be Trusted” program, requiring all dietary supplements “to be certified either by NSF International , a global public health testing, inspection and certification organization, or verified by USP (The United States Pharmacopeia), a nonprofit organization”. If the general public truly had faith in the supplement industry, there would be no need for third-party testing. It would be a colossal waste of time and money for CVS. But we anticipate CVS will benefit greatly from investing in transparency and consumer trust.
Thankfully, new companies emerging in the industry are well aware that in order to make way in the marketplace full ingredient transparency is key. Claims of organic, non-gmo, and non-toxic ingredients must be backed up by proof. Consumers don’t mind paying a premium for a product that comes with verifiable claims, and access to genuine customer service where questions are answered straight up. This is exactly what the supplement start-ups have understood, and are thus succeeding in taking a sizable piece of the supplement sales pie from Big Supplement.
All in all, while the majority of the supplement industry is questionable, there are companies out there putting up a fight to the madness, and working on bringing you genuinely reliable options.