Increasingly popular over-the-counter dietary supplements were responsible for more than half of all major drug recalls in the United States in the past decade and have been tied to a sharp spike in complaints to the Central Ohio Poison Center over the same period, according to new data from medical researchers and state officials.
Calls to the poison center about adverse reactions to dietary supplements, including heart palpitations, chest tightening and shortness of breath, have nearly doubled since 2003 in concert with the proliferation of pills for everything from weight loss to sexual enhancement, said Director Henry Spiller.
“Mostly, we get calls about weight-loss pills,” said Spiller, who tallied more than 600 supplement-related complaints last year to the poison center, which covers 44 counties including Darke, Champaign, Clark, Greene, Miami, Montgomery and Preble. “We try to find out what people have gotten into, but often they don’t know. The list of ingredients is often misleading on these products.”
Once relegated to the back rooms of gyms and health spas, nutritional supplements are now one of the fastest-growing industries in the world, generating $32 billion in sales last year, according to the Nutritional Business Journal, an industry publication.
That figure is expected to double by 2021, and many of the supplements sold are likely to contain pharmaceutical drugs unapproved for use as herbal or dietary aides.
Supplements with unapproved drug ingredients accounted for 90 percent of supplement recalls from 2008 though the end of last year, according to an analysis of U.S. Food and Drug Administration data by researchers at Michael’s Hospital in Toronto.
Between Jan. 1, 2004 and Dec. 19, 2012, supplement recalls accounted for 237 of 465 Class I drug recalls, the researchers reported.
“Most people are under the misconception that the supplements they are taking are safe because they are regulated and monitored by the FDA,’’ Spiller said. “But the impact of federal law was to remove the FDA from regulation of this area until someone is injured.”
Unlike prescription drugs, the Dietary Supplement Health and Education Act passed in 1994 prohibits the FDA from requiring safety or efficacy studies on supplements unless they are marketed as products that prevent, treat or cure a disease.
“We do not look at products before they go to market,’’ explained FDA spokeswoman Tamara Ward.
‘There is no quick fix’
That’s simply irresponsible, according to Richard Cohen, a dietitian at Kettering Weight Loss Solutions and who blames lobbyists and special interest groups for influencing lawmakers to disregard public safety when it comes to supplement regulation.
He said the supplement law allows manufacturers to “come up with these crazy concoctions” that appeal to consumers who are most vulnerable to their sales pitches.
“We have an epidemic of obesity in this country, and people are desperate,” Cohen said. “They’re looking for a quick fix, and that’s what these supplements promise. But there is no quick fix.”
Cohen said some over-the-counter weight-loss pills, including Alli, have been proven effective in helping overweight adults shed a few pounds. But the vast majority of dietary supplements are “not only ineffective but dangerous” over the long term, he said.
“There’s a right way and a wrong way to loose weight, and taking a pill is the wrong way,” Cohen said. “What are you going to do, stay on the medication for the rest of your life?”
While the dangers of unregulated supplements remain a concern, there were no reported supplement-related deaths in the Miami Valley last year and hospitalizations are rare, according to Spiller. But that doesn’t mean the threat is less real.
“It’s not like everyone that calls has to be rushed to the emergency room,’’ he said. “But it does happen, which is why these products shouldn’t be marketed as safe and effective when they’re not necessarily safe.’’
Unlike prescription drugs, the FDA must observe a complex protocol and go through a series of scientific evaluations and legal steps before it can ban ingredients in dietary supplements.
It can warn against certain products, but the warnings have proven ineffective in many instances and have not stopped the flood of potentially dangerous and lethal supplements from stacking up on store shelves.
Earlier this month, the FDA warned consumers not to use products containing the stimulant dimethylamylamine, or DMAA, after receiving reports of 86 illnesses, including a handful of deaths, over the past five years.
Despite the warning, an informal survey of supplement retailers by the Dayton Daily News last week found products containing DMAA, such as the original formulations of Jack3d and OxyElite Pro, still on the shelves at vitamin and supplement retailers.
“Whatever the public wants, they (supplement makers) will find a way to make it,” Spiller said. “The FDA can only ask for a recall if they find it to be either not what they said it was or dangerous. Even if the (FDA) outlaws an ingredient in a product, they’ll just reformulate it as some other concoction.”
Despite warnings from the Federal Drug Administration about the dangers of products containing the dimethylamylamine, or DMAA, the Dayton Daily News found products containing DMAA still on the shelves at vitamin and supplement retailers in the region.