If you’ve shopped for any kind of supplement, you’ve probably seen a disclaimer in the fine print that reads something like this:

“These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, cure, or prevent any disease.”

But what exactly does this mean and how does it affect you as a consumer? Read on as we take a peek inside the regulatory machine that is known as the Food and Drug Administration aka the FDA.

A Brief History of the FDA

Before the 1900s, basically anything was permissible when it came to what was marketed to people as food or medicine and what was in it. After the 1906 publication of The Jungle, a novel by Upton Sinclair, which described the horrid working conditions in the meat industry, and the adventurous experiments of a group of men dubbed The Poison Squad who purposefully ate foods laced with additives in 1902, did people begin to take notice of what they put in their bodies.

Thus, the Pure Food and Drug Act of 1906 was born and the Bureau of Chemistry was founded (the name changed to the Food and Drug Administration in 1930). This required manufacturers to list any ingredients deemed dangerous (like alcohol and cocaine) and monetary penalties or seizure could be enforced. The Act also prohibited “false and misleading” claims. 

One of the first tests of the new regulation was when the Bureau of Chemistry attempted to prosecute the makers of Dr. Johnson’s Mild Combination Treatment for Cancer for false claims, a case that went all the way to the Supreme Court.

Dr. Johnson’s Mild Combination Treatment for Cancer

The Government lost because the Court felt any therapeutic claim was a matter of opinion.  Because of this judgment an amendment to the law was passed, but this only prohibited knowingly false claims and didn’t extend into advertising.

The Food, Drug, and Cosmetic Act of 1938

While proper identification of ingredients foods and medicines was an important step, the FDA didn’t really have “teeth” until 1938, after a tragedy where a product called Elixir Sulfanilamide (which was essentially antifreeze with raspberry flavoring) killed 100 people. 

In response to the tragedy, the Food, Drug, and Cosmetic Act of 1938 was enacted, creating definitions for foods, drugs, medical devices, food additives, and dietary supplements. A drug was defined as an ingredient “intended for the diagnosis, cure, mitigation, treatment, or prevention of disease.” Companies marketing new drugs needed to fill out a New Drug Application (NDA), which had to include studies of its safety, but generally they would still be approved within 60 days if the FDA took no action.

The next big change came in 1962, when amendments were enacted to add proof of efficacy (meaning whether they actually work or not) before a drug was allowed to sold to the public. This set the stage for a battle between the Supplement Industry and the FDA, who began to take vitamin makers to court for the health claims of their products.  

The “Compromise” of 1994

In 1994, after intense lobbying from supplement makers, a compromise was reached. The Dietary Supplement and Health Education Act of 1994 (DSHA) allowed for dietary supplements (other than tobacco) like herbs, amino acids, minerals or vitamins to be introduced and sold to consumers without the need to prove safety or efficacy so long as they had the disclaimer we mentioned at the top of the article.

This essentially meant that pharmaceutical man-made drugs are considered unsafe for sale until they have been tested, while supplements are considered safe to sell without the need for any testing. Should a supplement be found dangerous after being introduced, it could be recalled or banned by the FDA.

What This Means to You

Depending on your beliefs, this is either a cornerstone of liberty (according to lobbying group National Health Freedom) or it weakened the FDA putting consumers in potential danger (according to Stephen Barrett, M.D. on the website Quackwatch).

The FDA contends that it has limited resources to investigate these supplements, instead focusing on pharmaceutical drugs, which they claim are a greater threat to the public health.

Proponents also claim the FDA has suppressed evidence that vitamins and other supplements have health benefits, while dangerous drugs sold by Big Pharma kill hundreds of thousands each year.

On the other side, many medical professionals question the vagueness of this “Miranda Warning” required by DHSA that relieve them of any burden to prove that their product is not harmful (or works at all). 

FDA Slow To Act

Because these supplements are rubber-stamp approved, it’s only after a problem arises that the FDA springs into action. In April of 2015, the agency came under fire when a group of scientists found that dietary supplements in the marketplace contained BMPEA, a variation of DMAA (an amphetamine) known to cause heart attacks and has been banned by the military. The FDA has yet to issue a warning or recall on BMPEA.  

On the other hand, some supplements may not even contain the ingredients they say. A 2015 investigation by the New York State attorney general found that many supplements on the shelves of GNC, Target, Walgreens, and Wal-Mart contained unrecognizable ingredients or herbs from a plant not listed on the label. 

What You Can Do

Until stronger regulation and/or enforcement is in place, the consumer has to be especially careful about products “not evaluated by the FDA or intended to diagnose, cure, or prevent disease.”

Paul A. Offit, chief of the division of infectious diseases at Children’s Hospital of Philadelphia and Sarah Eurush, clinical manager of its pharmacy wrote an Op-Ed in the New York Times urging people to Skip the Supplements.

“The F.D.A. estimates that approximately 50,000 adverse reactions to dietary supplements occur every year. And yet few consumers know this,” they wrote.

While many people are understandably hesitant to follow through on this advice, they recommend ensuring the supplement you are taking is at least certified pure by US Pharmacopeia, a company older than the FDA itself. Currently, only 1% of supplements have this label but you can find a list of them here.

US Pharmacopeia seal

In Conclusion:

  • Supplements, while generally considered safe, are essentially unregulated, largely thanks to lobbying efforts by the industry.
  • You should always look up supplement ingredients on sites like WebMD for uses, dosage and side effects. 
  • Look for the USP label!

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