FDA regulation

RECENT POSTS

Study: Dietary Supplement To Boost Sexual Performance Often Mislabeled, Posing Risks

If you’re not a man in the market for a natural way to boost your sexual performance, you may be unfamiliar with yohimbe. It’s an African tree whose bark yields a substance, yohimbine, which can be extracted and used as an aphrodisiac.

But for those who seek this common supplement, beware: according to a new study by Harvard researchers, the vast majority of yohimbe sold as a dietary supplement by mainstream retailers in the U.S. is mislabeled in a way that could pose a safety risk to consumers.

Dr. Pieter Cohen, an assistant professor at Harvard Medical School who studies dietary supplements, says of the 49 yohimbe products he and his colleagues tested, most had inaccurate data either about the quantity of active ingredient or an incomplete list of known side effects.

“These are completely misleading in terms of labels,” Cohen, the lead author of the new study and an internist at Cambridge Health Alliance, said in an interview. “If safe consumption of a product requires that both accurate quantity as well as known adverse effects be provided on the label, then only 4.1 percent of the yohimbine supplement brands analyzed provided sufficient safety information for consumers.”

(Rachel Zimmerman/WBUR)

(Rachel Zimmerman/WBUR)

But the real problem, Cohen says, is the federal law governing dietary supplements which regulates such products more like food than drugs and doesn’t require the kind of stringent pre-market testing for safety and effectiveness mandated for prescription drugs. “Every problem we found with yohimbe supplements brings us back to fundamental flaws in the law,” Cohen said.

Here’s the conclusion of his study, published today in the journal Drug Testing and Analysis: Continue reading

Legal Experts Call For More Regulation Of Mobile Health Apps

smartphone (Stephan Geyer/Flickr)

(Stephan Geyer/Flickr)

Veronica Thomas
CommonHealth Intern

Want to hypnotize yourself thin? There’s an app for that. Want to monitor your heart rate without buying another gadget? There’s an app for that too. With the emergence of countless mobile health applications, smartphones are quickly transforming health care at our fingertips.

Mobile health—“mHealth”—apps have the potential to help promote healthy behaviors, expand health care access, and manage costs. But in order to protect the safety of consumers, health law experts say there needs to be more regulation by the Food and Drug Administration.

According to the new report, just published in the New England Journal of Medicine, only about 100 out of 100,000 mHealth apps available on the market have been FDA-approved.

Many mobile health developers, however, worry that FDA oversight will hinder creativity and growth. The FDA approval process can cost tens of thousands of dollars and take months or even years to complete. Before committing time and money to FDA endorsement, many developers first look to consumers for a stamp of approval.

From the study’s press release:

“Consumers will be spending a lot of money on these products, and venture capital is flying into the industry,” says the article’s lead author, SMU Dedman School of Law Associate Dean of Research Nathan Cortez, adding that by 2017 mHealth apps are expected earn $26 billion— up from $2.4 billion in 2013.

The FDA needs “additional funding and in-house technical expertise to oversee the ongoing flood of mHealth products,” the authors note. An under-regulated mobile health industry could create “a Wild West” market, says Cortez, who has conducted extensive research into FDA regulation of mobile health technologies.

While consumers might trust that iTunes and Android would only sell legitimate health apps cleared by the FDA, that just typically isn’t the case, Cortez says. Continue reading