Study says more efforts needed to regulate dietary supplements

April 18, 2013

Dietary supplements accounted for more than half the Class 1 drugs recalled by the U.S. Food and Drug Administration from 2004-12, meaning they contained substances that could cause serious health problems or even death, a new study from St. Michael's Hospital has found.

The majority of those recalled supplements were bodybuilding, weight loss or sexual enhancement products that contain unapproved medicinal ingredients, including steroids, said the study's lead author, Dr. Ziv Harel.

Almost one-quarter of the substances are manufactured outside of the United States, he said in the study published online in the journal JAMA Internal Medicine.

Unlike , do not require before they can be sold. The FDA defines a dietary supplement as a product taken by mouth that contains a "" such as vitamins, minerals, herbs, other botanicals, or substances such as metabolites. There are about 65,000 dietary supplements on the market consumed by more than 150 million Americans.

Of the 465 drugs subject to a Class 1 recall in the U.S. between Jan. 1, 2004, and Dec. 19, 2012, 237 or 51 per cent were dietary supplements. The majority of recalls occurred after 2008 for reasons unknown, the researchers said.

Supplements marketed as sexual enhancement products were the most commonly recalled dietary supplements (95, or 40 per cent).

Dr. Harel, a whose research focus is patient safety, said that when the FDA learns of an adulterated dietary supplement, it is required to contact the manufacturer to trace the source of the product and initiate a recall. However, a recent investigation by the Office of the Inspector general determined that the FDA does not possess accurate contact information for 20 per cent of supplement manufacturers.

The FDA has recently introduced a number of initiatives aimed at mitigating the impact of the most common adulterated supplements, including the creation of multinational enforcement groups and widespread media campaigns focusing on improving awareness.

"Despite these initiatives, products subject to Class I recalls continue to be readily available for sale, which may be due to an increasingly complex distribution network associated with these products, as well as ineffective communication by the FDA to consumers," Dr. Harel said.

"We also found a number of recalled products to be manufactured outside of the U.S. where manufacturing practices may not be subject to the same oversight and regulation required of domestic companies."

Dr. Harel said increased efforts are needed to regulate this industry. "Keeping the status quo may taint the dietary supplement industry as a whole."

Explore further: FDA warns consumers of dangers of the stimulant DMAA

Related Stories

FDA warns consumers of dangers of the stimulant DMAA

April 15, 2013
(HealthDay)—The U.S. Food and Drug Administration is attempting to halt distribution of dietary supplements that contain the stimulant dimethylamylamine (DMAA), following reports of illness and death associated with these ...

FDA seizes illegal dietary supplements in Florida

February 14, 2013
(AP)—The Food and Drug Administration says U.S. marshals have seized illegal dietary supplements from a Florida company because some may contain a dangerous pharmaceutical ingredient.

Ensuring high-quality dietary supplements with 'quality-by-design'

October 3, 2012
If applied to the $5-billion-per-year dietary supplement industry, "quality by design" (QbD)—a mindset that helped revolutionize the manufacture of cars and hundreds of other products—could ease concerns about the safety ...

Recommended for you

Expert: Be concerned about how apps collect, share health data

October 20, 2017
As of 2016 there were more than 165,000 health and wellness apps available though the Apple App Store alone. According to Rice University medical media expert Kirsten Ostherr, the Food and Drug Administration (FDA) regulates ...

Three million Americans carry loaded handguns daily, study finds

October 19, 2017
An estimated 3 million adult American handgun owners carry a firearm loaded and on their person on a daily basis, and 9 million do so on a monthly basis, new research indicates. The vast majority cited protection as their ...

More teens than ever aren't getting enough sleep

October 19, 2017
If you're a young person who can't seem to get enough sleep, you're not alone: A new study led by San Diego State University Professor of Psychology Jean Twenge finds that adolescents today are sleeping fewer hours per night ...

Across Asia, liver cancer is linked to herbal remedies: study

October 18, 2017
Researchers have uncovered widespread evidence of a link between traditional Chinese herbal remedies and liver cancer across Asia, a study said Wednesday.

Eating better throughout adult years improves physical fitness in old age, suggests study

October 18, 2017
People who have a healthier diet throughout their adult lives are more likely to be stronger and fitter in older age than those who don't, according to a new study led by the University of Southampton.

Global calcium consumption appears low, especially in Asia

October 18, 2017
Daily calcium intake among adults appears to vary quite widely around the world in distinct regional patterns, according to a new systematic review of research data ahead of World Osteoporosis Day on Friday, Oct. 20.

0 comments

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.