Time to tame the dietary supplement industry

The FDA should regulate vitamins and herbal remedies, but bad science, lobbyists and big money have gotten in the way

November 12, 2013 6:00AM ET
Omega-3 capsules on a production line at Sancilio and Co.'s lab and manufacturing facility in Riviera Beach, Fla.
Mark Elias/Bloomberg/Getty Images

Once upon a time, traveling salesmen went from town to town selling tonics bubbling with opiates, cocaine and knockout quantities of grain alcohol. The Pure Food and Drug Act shut them down in 1906.

The hucksters are back. The vitamin, mineral and herbal supplement industry — now a $23-billion-a-year business — is hawking wares with dubious claims and unproven safety records to an unsuspecting public. Whether you shop at Wal-Mart or high-priced organic-food stores, you will find shelves of supplements that claim to be as basic to personal health as whole grains and toothpaste.

Industry executives claim that they are promoting "health freedom." But they are actually exploiting people's genuine health concerns and anxieties over the skyrocketing cost of traditional medical care. The supplement moguls — along with their retinue of lobbyists, political allies, celebrity endorsers, media promoters and alternative-medicine gurus — are fighting off government oversight so that they can continue bamboozling the public into thinking that good health comes in a bottle. The Food and Drug Administration needs to intercede.

According to Consumer Reports, only a third of 54,000 supplements in the Natural Medicines Comprehensive Database have any scientifically supported level of safety and effectiveness, and 12 percent are linked to safety concerns or quality issues. Mounting evidence suggests that most vitamin supplements, including the popular daily multivitamin, may be useless — and some could even increase the risk of disease.  

Quality control is also a concern. Many vitamins that appear in the U.S. — in everything from soft drinks to breakfast cereal — are made in China, where standards are lax. When consumers buy children's chewables, they fail to realize that the lack of uniform manufacturing rules can result in mislabeling or contamination. A recent New York Times report on herbal supplements reveals that popular products like echinacea may be diluted or contain nothing more than cheap fillers like rice.

Supplement promoters sell themselves as an alternative to big pharma, but giant pharmaceutical firms actually own the bulk of the industry. Pfizer owns Centrum, Bayer owns One a Day, and Procter & Gamble owns supplement maker New Chapter. Even Wall Street is getting in on the action. The Carlyle Group, a private-equity giant, owns NBTY (formerly Nature's Bounty), and hedge funds are trading on industry players like the Vitamin Shoppe, betting that health-conscious baby boomers and other promising demographics will keep buying.

To be sure, humans need vitamins and minerals, but outside of a few specific cases of diagnosed deficiencies, like folic acid for pregnancy, there is little evidence that consuming them in supplement form is generally beneficial. Most major health bodies — including the National Institutes of Health, the American Academy of Pediatrics, the American Dietetic Association, the Mayo Clinic and Harvard Medical School — do not recommend supplements because their alleged benefits have failed to withstand scientific scrutiny.

Paul Offit, the chief of the infectious-disease unit at Children's Hospital of Philadelphia and a critic of the supplement industry, lays out the scientific case against high doses of vitamins in his book "Do You Believe in Magic? The Sense and Nonsense of Alternative Medicine." Steven Novella, a clinical neurologist at the Yale School of Medicine, co-founded a website that investigates the myriad false claims made by the supplement industry.

Yet the U.S. government has failed to catch up with the science. Under current law, dietary supplements are considered neither food nor drugs and exist in an unregulated gray area. You can put supplements in a shake, stick them in a pill or add them to water without testing their safety.

The supplement industry has spent huge sums of money to beat back any regulatory challenges.

Corporate giants in the supplement industry have maintained their free hand by courting select politicians. The Congressional Dietary Supplement Caucus (yes, there is such a thing) boasts power brokers from both parties, such as Sen. Orrin Hatch, R-Utah, and Sen. Tom Harkin, D-Iowa.

Hatch is a hero in Utah County, Utah — a region known as the Silicon Valley of the nutritional supplement industry — for winning a key battle in 1994, when he and Harkin pushed the Dietary Supplement Health and Education Act through Congress. The law allowed supplement manufacturers to test their products on a voluntary basis before selling them and blocked the FDA from regulating them unless there was evidence of harm. Thanks to the senators' efforts, the U.S. population became guinea pigs.

Hatch's industry ties encompass former aides and family members, including his son, a supplement lobbyist in Washington. The pharmaceutical and health-products industry ranks as Hatch's second-biggest financial supporter.

Harkin, a big believer in bee pollen, has enjoyed close financial ties — including campaign funding and money for various projects — to Herbalife. The company, a direct seller of supplements, is currently under scrutiny by the New York State attorney general for quality-control and safety issues. It has faced allegations from activist hedge-fund manager Bill Ackman and others that it is a pyramid scheme. Throughout Harkin's long congressional career, which will end in January 2015, he has won fans in the supplement industry, thanks to his help in creating the Office of Alternative Medicine (OAM) and to his appropriation of millions of dollars to establish the National Center for Complementary and Alternative Medicine. Both agencies have been criticized by scientists — including Novella, Offit and University of Maryland genome researcher Steven Salzberg — for promoting pseudoscience at taxpayer expense. From 2007 to 2012, Herbalife and its executives were Harkin's fifth-biggest donors. The company has also been quite generous to Hatch.

Along with courting allies, the supplement industry has spent huge sums of money to beat back any regulatory challenges.

Sen. Dick Durbin of Illinois has tried repeatedly to pass the Dietary Supplement Labeling Act to improve information available to consumers and crack down on drinks and food that dodge FDA oversight. Sen. John McCain sponsored the Dietary Supplement Safety Act, which would require supplement manufacturers to register with the FDA and disclose their ingredients and give the FDA the authority to recall unsafe supplements. Neither effort has succeeded.

Beyond Congress, the industry has won key support from libertarian elements on both the right and the left who promote conspiracies about how the government, big pharma and scientists work together to misinform the public about supplements. On the right, the Dahlonega Tea Party denounces government interference and likens the FDA to the "most terrifying villain in the worst horror movie you've ever seen." On the left, alternative health guru Gary Null touts vitamin supplements as the antidote to mainstream medicine and big pharma — even after accidentally poisoning himself with his own products. Together they favor a laissez-faire attitude that allows them to exploit the public's ignorance and anxieties about health and medicine.

The FDA needs authority as well as added funding and staff to monitor the effectiveness and safety of dietary supplements and to make them transparent to the public. It is time for American consumers to know exactly what they are swallowing.

Lynn Stuart Parramore is a contributor to Al Jazeera America, Reuters, Huffington Post and other venues.

The views expressed in this article are the author's own and do not necessarily reflect Al Jazeera America's editorial policy.

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