Commentary

Anti-Aging Pill Looks To Skirt FDA As Supplements Draw Action By N.Y. AG

An anti-aging pill that is backed by five Nobel laureates and some serious science — albeit on mice — “is wading into the murky world of dietary supplements,” the Boston Globereports, in order to avoid all of the testing required by the Food and Drug Administration to allow it to be sold as a medicine.

The active ingredients in the pill, which is called Basis and will cost $60 for a 30-day supply, “are nicotinamide riboside, a substance that makes NAD and is found in traces in many foods such as milk, and pterostilbene, an antioxidant found in blueberries,” reports Stefanie Friedhoff, who adds that both are available individually as supplements.

“There have been a lot of new findings in the past five years identifying some extremely promising compounds that promote wellness and health. [We want to] make them available for people to improve their health before they get sick,” Leonard Guarente, Elysium Health founder and its chief scientific officer, tells Friedhoff. 

Elysium Health was founded in 2014 to bring scientific validation to the world of consumer health products,” according to its website. “Our team of researchers and collaborators comprises the world's top 0.01% of scientists and clinicians, including multiple Nobel Prize winners and numerous other thought leaders, pioneers, and innovators who are at the top of their fields.”

The company “hopes to elude the U.S. Food and Drug Administration and death at the same time,” is the way Karen Weintraub puts it in the MIT Technology Review. Indeed, “with Elysium, Guarente and his colleagues are entering an industry with a mixed reputation,” Friedhoff writes.

The New York Timesbreaks the story that the New York State Attorney General’s office yesterday issued cease-and-desist orders to GNC, Target, Walgreens and Walmart. It demanded that they stop selling “adulterated and/or mislabeled herbal dietary supplements, and in particular to immediately stop the sale of five ‘Herbal Plus’ dietary supplements” that the letter subsequently identify by lot number. The letter also asks them to “explain what procedures they use to verify the ingredients in their supplements.”

The investigation was prompted by a story published in the Times in November 2013 by Anahad O’Connor that reported that “DNA tests show that many pills labeled as healing herbs are little more than powdered rice and weeds.” 

The letter sent yesterday confirmed that assertion.

“The authorities said they had conducted tests … [that] showed that pills labeled medicinal herbs often contained little more than cheap fillers like powdered rice, asparagus and houseplants, and in some cases substances that could be dangerous to those with allergies,” O’Connor writes.

In response to the finding, O’Connor reports, Walgreens said it will “remove the products from its shelves nationwide”; Walmart said it would “take appropriate action” with its suppliers; GNC said it will cooperate with the attorney general but “stood behind the quality and purity of its store brand supplements.” Target did not respond to a request for comment.

Regulation of the supplement industry is a controversial issue. 

“The nutritional supplement industry is astonishingly under-regulated,” Peter Ubel, a physician and behavioral scientist at Duke University, wrote in a piece on Forbes.com last June, citing an article in the New England Journal of Medicine that pointed out the large number of pharmacologically active substances in supplements.

“More than 500 supplements have already been found [by the FDA] to be adulterated with pharmaceuticals or pharmaceutical analogues, including new stimulants, novel anabolic steroids, unapproved antidepressants, banned weight-loss medications, and untested sildenafil [Viagra] analogues,” according to Dr. Pieter Cohen, the author of “Hazards of Hindsight — Monitoring the Safety of Nutritional Supplements.”

Cohen pointed out that “Americans spend more than $32 billion a year on more than 85,000 different combinations of vitamins, minerals, botanicals, amino acids, probiotics, and other supplement ingredients.” But, citing the case of an over-the-counter supplement that was responsible “for a cluster of cases of severe hepatitis and liver failure,” the government’s monitoring of supplement safety is “woefully inadequate” he says.

The supplement industry, however, claims that the vast majority of its products are safe and believes that excessive regulation will put it out of business.

In direst response to an NPR interview with Sen. Dick Durbin (D-Ill.), co-sponsor of the Dietary Supplement Labeling Act of 2013, a post on The Alliance for Natural Health website charged that the bill would “[clear] the way for Big Pharma to take over with their synthetic versions of the same products — at prescription prices. And as we noted last month, 157 million Americans — half the U.S. population — take supplements each year, but less than one-hundredth of one percent of them have adverse effects from them — an average of only 1,575 per year. By comparison, there are on average 526,527 adverse events for prescription drugs each year — 275,421 of which have ‘serious outcomes,’ including death.”

Consumers Union, which ran a cover story in September 2012 on the risks and dangers of various supplements 2012, supported the bill, which apparently languishes with the symptoms of a larger malaise.

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