What my mom didn’t tell me about buying supplements and what I’m about to tell you could save you hundreds of dollars in worthless purchases or worse yet.. an ineffective and potentially dangerous supplement!
How Does a Supplement Become a Supplement?
To answer this question, what better place to get the information then the FDA’s own website.
“The FDA regulates dietary supplements under a different set of regulations than those covering “conventional” foods and drug products (prescription and Over-the-Counter). Under the Dietary Supplement Health and Education Act of 1994 (DSHEA), the dietary supplement manufacturer is responsible for ensuring that a dietary supplement is safe before it is marketed. FDA is responsible for taking action against any unsafe dietary supplement product after it reaches the market. Generally, manufacturers do not need to register with FDA nor get FDA approval before producing or selling dietary supplements. Manufacturers must make sure that product label information is truthful and not misleading.
FDA’s post-marketing responsibilities include monitoring safety, e.g. voluntary dietary supplement adverse event reporting, and product information, such as labeling, claims, package inserts, and accompanying literature. The Federal Trade Commission regulates dietary supplement advertising.” –Source: The FDA
Does this mean a manufacture can do some in-house testing, package a product, make claims and put it on the market? Absolutely. The FDA has really taken a major step back in regulation beginning in 1994. What this means to the consumers is that, the FDA will be responsible for taking action against any unsafe dietary supplement AFTER it reaches the market.
Look at the case of Ephedra. Let’s not argue the safety as there are numerous cases on both sides that have done that for months. The amount of posts and facts becomes overwhelming. Let’s just look at that particular product in regards to the FDA’s current role. Ephedra was released with claims and the proper labeling. And it was only AFTER it hit the market, and a few incidences occurred that the FDA finally stepped in and effectively banned the sale of Ephedra. They had been targeting that supplement for a long time. With the media frenzy, they were able to get the momentum they needed. This is an example of their post-marketing responsibilities. Many products can be released and the only real stipulation is that the ingredients contained are accurate. Regulation of claims may be under the FTC, but I think most consumers know or will know after reading this, that most claims go unregulated unless there is some promise or totally unacceptable claims. But increasing muscle mass in 30 days or helping you shed unwanted pounds, are claims that will stay on bottles.
To the consumer, this means, it’s really important you read about a particular supplement and the ingredients and monitor how it affects you. Because it’s in a store and sold, does in no way mean there may not be any adverse effects. Please re-read the above section. The FDA will become involved AFTER the product hits the market. Which means you could very well be taking it and it’s not safe for you. So consumer education becomes even more important in the industry that is vastly unregulated. While this task might seem impossible, it’s not. There’s plenty of information contained in the pages you are reading to further your understanding of particular products and how they related to you.
Who Has The Responsibility For Ensuring That A Dietary Supplement Is Safe?
By law (DSHEA), the manufacturer is responsible for ensuring that its dietary supplement products are safe before they are marketed. Unlike drug products that must be proven safe and effective for their intended use before marketing, there are no provisions in the law for FDA to “approve” dietary supplements for safety or effectiveness before they reach the consumer. Also unlike drug products, manufacturers and distributors of dietary supplements are not currently required by law to record, investigate or forward to FDA any reports they receive of injuries or illnesses that may be related to the use of their products. Under DSHEA, once the product is marketed, FDA has the responsibility for showing that a dietary supplement is “unsafe,” before it can take action to restrict the product’s use or removal from the marketplace. –Source: The FDA
Just one more reason that the consumer needs to clearly be aware of the product, what it contains and what that means.
Tell the Truth & Have Scientific Evidence to Back-up Those Claims
The REAL problem with most supplements is they are based on little evidence, a few questionable testimonals and make wild claims about unrealistic expectations. In fact…
“The FTC’s primary issue with dietary supplements relates to claims that cannot be supported by reliable scientific evidence.” - Marc Ullman, of Ullman, Shapiro & Ullman in New York City
To say that supplements are like religion where it’s “faith” based per se, would get a laugh from many. And yet MILLIONS of consumers each year toss away money on bodybuilding supplements, weight loss supplements in hopes they will work. Hopes? Scientific evidence should be available to support those claims. If not, then buyer beware!
As a consumer there’s no single direct answer which makes it frustrating but you CAN do something. A tiny bit of research on your own will reveal a lot of information about a supplement beyond the marketing materials and customer testimonials. You need to do a little more thought when it comes to putting substances into your body. While the FDA and FTC do work to eliminate fast buck companies that show little or no corporate ethics or responsibility, it’s still very important that the consumer does some research beyond the ads and testimonials.
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