Consumer Reports calls supplement industry "unregulated'

Marvin Lipman, M.D., Consumer Reports' chief medical adviser and medical editor, said the U.S. dietary supplement industry is unregulated in his June Office Visit column. However, representatives from the Natural Products Association and Council for Responsible nutrition disagree, saying Dr. Lipman is incorrect with his assessment of FDA's regulatory power.

Under the subhead, " An unregulated industry," Lipman  gave a brief history of U.S. supplement law, saying the Dietary Supplement Health and Education Act in 1994 (DSHEA) was the result a lobbying campaign by supplement makers and marketers. He said the law passed "by a misguided Congress in the belief that it was protecting a consumers right to choose among health care options."

He said DSHEA prevents FDA from interfering with the marketing of supplements. "All regulatory barriers effectively swept aside, the industry exploded to the point that today some 55,000 products are on the market compared with just 4,000 in 1994," he wrote, adding if FDA wants to remove a supplement from the market, the law requires the agency to follow "a burdensome process" to prove the product is unsafe.

Cara Welch, Ph.D., vice president of scientific and regulatory affairs, NPA, said Dr. Lipman is wrong. "He says FDA doesn't have the power to regulate marketing of supplements. Actually, it does; it regulates the labeling of supplements, and FTC regulates the  advertising side. Between FDA and FTC, every aspect of marketing is regulated." Further, she noted the federal government is active in enforcement. "We've seen warning letters on claims from both FTC and FDA, so on that point, he's way off base."

Welch said Dr. Lipman is also wrong with FDA's ability to remove dangerous products from the market. "It's not an overwhelming burden. If there is an unsafe supplement, FDA has the ability to get a product off the market with the snap of the fingers. The thing is, most supplements are safe, so that's not a huge issue. He mentioned ephedra, and that is an example of when FDA used its power to remove a supplement. It's no longer a dietary ingredient. "

Judy Blatman, senior vice president, communications, CRN, said Dr. Lipman is a known critic of DSHEA. "We are not surprised by what we would call his mischaracterization of the law," she said. "In fact, we have reached out to him to provide CRNs perspective on some of the inaccuracies in his story, including the fact that the article calls the industry unregulated. At the end of the day, he may or may not agree, but we think its important to keep the lines of communications open." 

Blatman noted CRN is involved in making sure that legislative offices get the industry's perspective when articles talk about the industry being unregulated.  "We are regulated, and were doing our part to make sure that regulation is working," she said.

Dr. Lipman started the article with three scenarios where supplements put his patients in danger: a 74-year-old nurse who stopped taking her prescription drugs when she started supplementing with botanicals, a 23-year-old college study with a history of respiratory allergies who took Echinacea he received from a friend and a 75-year-old attorney with heart troubles who took large doses of ginkgo biloba.

Welch said these events could have been avoided if the consumers would have discussed their supplement use with their health care providers. "You have to be vigilant with what you put in your body. It's never a good idea to take a pill you get from a friend without knowing more about it."

Dr. Lipman also encouraged readers to report any adverse side effects that come from supplement use. He said  less than 1% of adverse reactions are ever reported.

"It's also important to report AERs (adverse event reports) to manufacturers as well," Welch said. "That's important because a manufacturer has to be aware if there are problems with their products. You can't know there's a problem with your product unless people contact you."

Consumer Reports is a known antagonist of the dietary supplement industry. In 2010, the publication released a cover story about " 12 dangerous supplements," which was an update from a 2004 list of "dirty dozen" supplements. Industry members argued most of the supplements on the lists were uncommon and the entire list accounted for less than 1% of the supplement market. Senior editor Steve Myers explored this issue in the Natural Products Insider's article " The media holography." In January 2012 Consumer Reports issued a correction after it used an inadequate test to determine fish oil products weren't fresh.

Recently, The Consumerist recently posted that its sister publication (Consumer Reports)  is looking for consumer stories about dietary supplements, good or bad. The site said it is looking for consumer takes on herbal remedies, vitamins, minerals, fatty acids and multi-ingredient supplements.