Helping Hearts For Over 30 Years

Enough Already: The Truth About the 'Unregulated' Supplement Industry

By Tracy Shields March 16, 2016 Leave a comment Go to comments

It seems that every time you turn around there’s a news article churning out the same myth: the vitamin supplement industry is not regulated. These articles tend to be written with authority, no less, and even appear in reputable news outlets like The Washington Post and Forbes.

The reality is that vitamin supplement companies face random inspections by the U.S. Food and Drug Administration (FDA) for label compliancy, language compliancy, ingredient compliancy and post-market surveillance —a program in place that mandates manufacturers of vitamin supplements to submit to the FDA serious adverse events while maintaining records for all adverse events.

Here are the facts, as cited by the Natural Products Association:

Dietary supplements are regulated as a category of food by the FDA.

  • Dietary supplements are the only category of food to have a federal mandatory reporting requirement for serious adverse events.
  • Dietary supplement quality, identity, purity, strength, potency, composition, limits on contaminants, (collectively termed Good Manufacturing Practices or GMPs), labeling and claims are regulated by the FDA. 
  • FDA’s dietary supplement GMPs are more stringent than conventional food GMPs.

Part of the misunderstanding and misinformation comes from the pharmaceutical industry, a direct competitor of the vitamin supplement industry. Aside from the obvious similarity that both industries fill capsules containing “stuff’ that you ingest, the similarity stops there.

Drug companies can and do create entirely new and foreign substances based on science, biology and chemistry.  The dietary supplement industry, however­—and more precisely, the natural supplements industry—takes nutrients and foods already found in nature and encapsulates those nutrients in a condensed form. Natural foods, in essence, should not be regulated like a drug because humans typically know how an orange or a fish or an acai berry affects the body. With drugs, we do not know how a foreign substance will affect us, and so, there are extremely stringent regulations. To compare a dietary supplement to a drug and to think they should be regulated the same way is to compare an apple to open-heart surgery. They are two different beasts, and should be approached with two different mindsets.

That’s not to say that dietary supplements should not be tested before hitting the market. Reputable, ethical manufacturers create and test products every day before they are sold. But, unlike a drug, single ingredients coming from plants and foods have been ingested for thousands of years. We have a body of knowledge passed down to us through generations, telling us what is safe to eat and what is not. And yet, dietary products are still tested, re-tested and tested again by scientists, researchers and chemists whose job is to study the safety and efficacy of nutrients. What’s more, those manufacturing facilities are inspected regularly by the FDA. And those ingredients, their quality, identity, purity, potency and composition are all very closely regulated by the FDA as well.

What confuses people, and what admittedly gives the dietary supplement industry a bad rap, are the criminal attempts of companies to create a drug—outside the law—and try to mask it as a dietary supplement. Take, for example, the case of Lamar Odom who had taken a reported 10 tablets of “herbal Viagra” and was then rushed to the hospital. Herbal Viagra is not a dietary supplement. It is an illegal, unapproved new drug pretending to be a supplement. And yet this fact did make it into much of the media coverage surrounding this incident.

In fact, one article in Forbes about the Odom overdose cites 23,000 incidents each year of ER visits due to supplements.  The Council for Responsible Nutrition puts this number in perspective:

To put the 23,000 emergency room (ER) visits figure into context: with over 150 million Americans taking dietary supplements every year, this study is estimating far less than one tenth of one percent of dietary supplement users experience an ER visit annually. If you look more closely at the study, you’ll realize it inaccurately included OTC and non-dietary supplement products in the researchers’ projections for dietary supplement-related ER visits, so the number of dietary supplement users experiencing an ER visit annually is even smaller when you eliminate the non-dietary supplement products.

The reality is that natural products do face regulatory scrutiny—and more people die from shark attacks and lightning strikes than from issues related to vitamin supplements.

Share and Enjoy