FDA Analysis: Hundreds of Dietary Supplements Tainted with Rogue Pharmaceuticals

When you buy supplements, you expect them to contain the advertised ingredients, right? And I’m sure you certainly don’t expect them to contain any pharmaceuticals, such as Viagra. But a U.S. Food and Drug Administration (FDA) analysis published in JAMA Network Open reveals that hundreds of dietary supplements actually contain pharmaceutical drugs. And yes, that includes Viagra, a drug that treats erectile dysfunction (ED). [1]

Researchers found unapproved and potentially dangerous drugs in 746 dietary supplements. The majority contained sexual enhancement drugs, but some contained weight-loss or muscle-growth drugs.

Read: Harvard Finds Amphetamine-Like Compound in Supplements

The team reviewed an FDA database of contaminated supplements from 2007 to 2016, and most of them tested positive for sildenafil, a.k.a., Viagra, as well as other ED drugs in sexual enhancement products. Additionally, the analysis found sibutramine and the laxative phenolphthalein, both banned by the FDA, in weight-loss supplements; and steroids or their analogues in muscle-building products.

Some of the Shocking Findings

Of the 746 supplements:

• 80% were contaminated by 1 pharmaceutical.

• 20% contained at least 2 pharmaceuticals.

• 2 of the supplements contained 6 unapproved pharmaceuticals.

• One supplement contained a drug that increases blood pressure and another drug that lowers it.

However, fewer than half of the products were recalled. What’s more, 97.6% of the pharmaceuticals found in the products weren’t listed on the products’ labels. [1] [2]

The authors of the report state that the presence of unknown pharmaceuticals in supplements “poses a serious public health risk.” Take Viagra, for instance. The erectile dysfunction medication can cause severe side effects, such as priapism (a painful, long-lasting erection), sudden hearing loss, increased intraocular (eye) pressure, heart arrhythmias, and even heart attack. [2] [3]

Watch: The Truth About Most Vitamins and Supplements

According to Medical News Today, sildenafil is particularly dangerous for men who:

• Take nitric oxide donors, nitrates, and organic nitrites;
• Are advised to avoid sexual intercourse because of cardiovascular risk factors;
• Have severe liver impairment;
• Have kidney disease;
• Have hypotension (low blood pressure);
• Have had a heart attack or stroke, and
• Have hereditary degenerative retinal disorders.

More than 50% of the U.S. population takes dietary supplements, believing them to be carefully regulated and accurately labeled. In reality, the FDA has little to do with supplements, unless it comes to light that something is wrong with them.

The Dietary Supplement Health and Education Act of 1994 dictates that dietary supplements are regulated as food. That means the products are not subjected to the same premarket safety and effectiveness testing as pharmaceutical drugs.

Dr. Pieter Cohen, a general internist at Cambridge Health Alliance in Somerville, Massachusetts, wrote in a commentary accompanying the study: [4]

“The agency’s failure to aggressively use all available tools to remove pharmaceutically adulterated supplements from commerce leaves consumers’ health at risk.”

Read: 4 Common Dangers Lurking in Your “Health” Supplements

Unlike Most Common Supplements

However, Daniel Fabricant, president of the Natural Products Association, a supplement industry trade group, says that sexual enhancement, weight-loss, and muscle-building products shouldn’t fall into the same category as vitamins and other traditional dietary supplements. The contaminated products found in the FDA database are “fringe products” made by unscrupulous manufacturers that are sold online or in convenience stores. [1]

As a general rule of thumb, if you wouldn’t eat gas station sushi, you shouldn’t take gas station supplements.

Fabricant said:

“We’re completely on the FDA’s side here. This is someone spiking the product. They’re saying it’s a supplement. It’s not a supplement in any way, shape, or form.”

He said he hopes the FDA will bring misdemeanor charges against companies that add pharmaceuticals to their so-called supplements.

We have to agree, especially considering previous research by Cohen and his colleagues shows that adulterated supplements continue to be sold in stores even after they’ve been recalled. They were left on the market possibly due to the FDA’s inability to reach manufacturers to get them to issue a recall. It is also possible that some of the companies simply denied the agency’s request to recall their products. [4]

Asleep at the Wheel

Though the FDA does not regulate supplements, the agency is not powerless to stop shady companies that manufacture adulterated products. The health watchdog can send companies warning letters, visit factories, and issue mandatory recalls.

The study found, however, that the FDA rarely dips into its bag of tricks to stop the sale of potentially-dangerous products. Out of the 146 companies involved in the manufacturing of the tainted supplements, the FDA issued just 7 warning letters. No mandatory recalls were ordered.

Cohen said:

“There’s just no way to interpret this other than the FDA is simply not doing its job.”

A viable solution to the problem would be for Congress to change dietary-supplement regulations to force companies to register supplements with the FDA before they can sell them. That would require each supplement to have an identifying registration code that would allow the FDA to know exactly what supplements are being sold in the United States. If a supplement was found to be tainted, the agency could “deactivate” the code so customers couldn’t buy it, Cohen explained.

Sources:

[1] The Washington Post

[2] Forbes

[3] Medical News Today

[4] Scientific American