On January 18, 2017, then Congressman Tom Price (R, Georgia) testified before the Senate Health, Education, Labor and Pensions Committee. Price was Donald Trump’s pick to serve as Secretary of the Department of Health and Human Services. Not surprisingly, most of the questions—and most of the media’s attention—centered on Price’s views on the Affordable Care Act. One question and answer, however, went entirely unnoticed.
“One of the essential duties of the HHS Secretary is to be diligent and thoughtful when considering if federal regulation is necessary,” said Orrin Hatch (R, Utah). “Do you recognize dietary supplements in helping reach and maintain healthy lifestyles?” Price answered without hesitation. “Absolutely,” he said.
Given his efforts on behalf of the dietary supplement industry two decades earlier, Hatch’s question was predictable.
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In the early 1990s, David Kessler, the director of the Food and Drug Administration (FDA), wanted to regulate dietary supplements. Kessler worried that salespeople in health food stores were giving advice on how supplements could treat high blood pressure, enlarged prostates, joint pain, high cholesterol, and the common cold. “Unsubstantiated claims are becoming more exaggerated,” said Kessler. “We are back at the turn of the century, when snake oil salesmen could hawk their potions with promises that couldn’t be kept. If you walk into a health food store, you have to recognize that we have not approved the safety of these products nor substantiated their claims.”
In 1991, in an attempt to hold the dietary supplement industry to a higher standard, Henry Waxman (D, California) introduced the Food, Drug, Cosmetic, and Device Enforcement Act. Orrin Hatch opposed it. At the time, four of the dietary supplement industry’s top 30 manufacturers were located in Utah. In fact, Utah was the only state that had its own supplement trade association.
With the considerable resources of the dietary supplement industry behind him, Orrin Hatch led a successful effort to defeat Henry Waxman’s bill. Later, again with the help of Hatch, the supplement industry introduced a bill of its own— the Dietary Supplement and Health Education Act (DSHEA). On May 11, 1994, DSHEA became law. The FDA was now specifically prohibited from regulating dietary supplements, which were defined as, “A product intended to supplement the diet that bears or contains one or more of the following ingredients: a vitamin, a mineral, an herb or other botanical, or an amino acid.” The New York Times called it the “Snake Oil Protection Act.” Consumers were now on their own, forced to trust a profitable, unregulated industry that directly impacted their health.
Recently, DSHEA has been weakened by laws that allow the FDA to hold dietary supplements to a labeling and manufacturing standard. Unfortunately, given the number of supplement manufacturers, the number of dietary supplements on the market (about 85,000), and the lack of FDA manpower, FDA oversight, for all practical purposes, doesn’t exist. Further, the FDA has no authority to compel supplement manufacturers to prove that their products are safe or effective before selling them. The agency can only react when something goes wrong—when it’s too late. For example:
• In 2004, the FDA recalled dietary supplements containing the stimulant and weight-loss product, Ephedra, which had been shown to cause hundreds of cases of psychosis, hallucinations, paranoia, depression, irregular heartbeats, strokes, heart attacks and at least 15 deaths. One man, after taking Ephedra for ten days, jumped out of a second-story window to escape imagined attackers. Another, Baltimore Orioles pitcher Steve Bechler, died of a heart attack within 24 hours of taking the drug.
• In February 2013, a study published in the Journal of the American Medical Association showed that vitamin D supplements contained anywhere from 9 percent to 146 percent of the amount listed on the package label. The FDA requires pharmaceutical products to be within 10 percent of the listed quantity.
• In July 2013, the FDA recalled vitamin C and vitamin B preparations made by the ironically named Purity First company when these products were found to contain methasterone, an anabolic steroid. The FDA acted when it found that the vitamin preparations had caused masculinizing symptoms in at least 29 people in the Northeast.
• In October 2013, the FDA withdrew a weight loss product called OxyElite Pro when it was found to cause 56 cases of acute liver failure or acute hepatitis. One person died and three others required life-saving liver transplants.
• In December 2013, seven children between 6 months and 4 years of age were admitted to the hospital with severe vitamin D intoxication when the fish oil supplement they had been given contained 4,000 times the quantity of vitamin D listed on the label. The ingestion of massive quantities of vitamin D had caused these children to suffer dangerously high concentrations of calcium in the their bloodstreams, which can cause fatal heart dysrythmias.
• In February 2014, the FDA recalled L-citrulline, an amino acid used to treat children with certain genetic or metabolic disorders. The product actually contained N-acetyl leucine, a different amino acid.
• In September 2014, an herbal cough-and-cold remedy called Bo-Ying was found to contain dangerously high levels of lead. The product, which the manufacturer recommended for children between 1 and 10 years of age, caused lead intoxication in at least one 18-month old child in New York City.
• In October 2014, an 8-day-old premature infant died in Connecticut’s Yale-New Haven Hospital after ingesting a probiotic called ABC Dophilus Powder, which unknown to the manufacturer who made it or the doctors who prescribed it, contained a mold called Rhizopus oryzae. This mold, which is typically found in decaying vegetable matter, was also found in the child’s bloodstream at the time of death. Later, the FDA found the same mold in several unopened bottles of the powder.
• During the past few years, weight loss products containing sibutramine and potency products containing sildenafil (Viagra) have been pulled from the shelves on an almost weekly basis. These potent pharmaceutical products were never listed on the package labels. Sibutramine, which has been banned from the United States as well as 40 other countries, has been associated with heart attacks and strokes.
Supporters of the dietary supplement industry argue that pharmaceutical products can also have severe side effects. For example, antibiotics can cause severe and rarely fatal allergic reactions and chemotherapeutic drugs can suppress the immune system, leading to fatal bacterial, viral or fungal infections. The difference, however, is that the consumer can learn about the side effects of pharmaceutical products by reading package inserts. For dietary supplements, package inserts don’t exist. What most people don’t realize is that side effects from dietary supplements are due to the poor quality of the product, not inherent problems with the supplement itself. Consumers treating their children’s ear infections with amoxicillin, for example, can be reassured that the product actually is amoxicillin, and not Viagra; that the product contains 100 milligrams of amoxicillin and not 400,000 or 0 milligrams; that the product isn’t contaminated with a mold; and that the product doesn’t also contain dangerous quantities of lead or other heavy metals.
Most people assume that when it comes to dietary supplements, someone is watching. But they’re not. And until the FDA regulates this industry, people purchasing dietary supplements from a health food store are doing so at their own risk.
Tom Price, the new Secretary of Health and Human Services, which includes the FDA, could do something about this if he chooses. Unfortunately, given his response to Orrin Hatch’s question during his confirmation hearing, it doesn’t sound like he’s interested.
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Paul A. Offit, MD, is a professor of pediatrics at the Perelman School of Medicine at the University of Pennsylvania and the author of Pandora’s Lab: Seven Stories of Science Gone Wrong (National Geographic Press, April 2017)
