In the hour-long segment that aired last night on PBS stations, titled “Supplements and Safety,” correspondent Gillian Findlay dredged up many talking points that have been echoed by long-standing critics of the industry. Among those interviewed were Dr Paul Offit of the Children’s Hospital of Philadelphia and Dr Pieter Cohen of the Harvard Medical School as well as New York Attorney General Eric Schneiderman. On the industry side Findlay interviewed Adam Ismail, executive director of GOED speaking to the science behind omega-3s, and Fabricant, who is the executive director of the Natural Products Association and was formerly director of the Division of Dietary Supplement Programs at the Food and Drug Administration.
Poorly regulated, unsafe, ineffective
The overall point of view of the show, which was produced in partnership with The New York Times, was that supplements are poorly regulated and potentially unsafe. The writers of the show also went to lengths to claim that there is little evidence of efficacy, and attacked the science behind omega-3s and multivitamin supplements.
In the most serious issue raised in the show, Findlay grilled Fabricant on the course of the investigation into the cases of liver injury in Hawaii associated with a tainted product called Oxy Elite Pro, marketed by USP Labs. Findlay’s point of view was that it took FDA, where Fabricant was employed at the time, too long to respond to the event, and the segment quoted Hawaii transplant surgeon Linda Wong who said it was hard to get the agency’s attention via the Medwatch system of adverse event reporting. In the end there were more than 50 cases of liver injury associated with the event, and two patients required liver transplants. The poisoning was traced to the company’s use of a tainted lot of synthetic aegiline from a Chinese supplier. Aegline, a molecule which can be found as a constituent of the fruit of the Bael tree, has been deemed by FDA as an unlawful dietary ingredient.
“I can’t respond to hearsay,” Fabricant was quoted in response to the Medwatch criticism. But as far as Oxy Elite Pro event itself was concerned, he said it was an example of FDA moving quickly when proper documentation was available. “We have to generate evidence that will stand up in court,” Fabricant said.
In another tainting episode, the show cast the owners of Purity First Products, a Long Island-based supplement marketing firm, in the curious role of well-meaning victims of a shoddy contract manufacturer. In 2013 the firm recalled lots of three vitamin products which were found to be tainted with anabolic steroids. This event was portrayed as an example of weak FDA oversight, as the owners were quoted as saying that agency investigators told them not to worry too much about the adverse event reports connected to their products. Findlay did quote FDA as denying those conversations took place.
Fabricant, in speaking with NutraIngredients-USA after the show aired, said that there was no attempt to put the assertions into proper context. In the discussion of DNA test results, there was no mention of the issue of products featuring herbal extracts being tested for DNA when little or no DNA of the parent material would be expected to be in the bottle. This critical issue was passed off by Findlay as saying that industry “disputed the methodology.”
“I think a lot of this was just patently dishonest,” he said. “For example, when they attacked the efficacy of fish oil . . . how did a drug get approved based on fish oil? Clearly there’s something there.”
Fabricant also said that the Hawaii episode transpired during the government shutdown that was orchestrated by the Republican party. From his point of view, it was a case of the agency turning on a dime, not the inefficient response that was portrayed by the show’s producers.
“I got that done in 15 days during the furlough,” Fabricant said.
Overall, he said that despite the show’s rehash of familiar talking points from industry critics there is evidence of progress.
“I think we stood our ground. We’ve got a good story to tell and we’re going to tell it,” Fabricant said. “I think we are changing the dialogue. If you go onto the PBS website, the message used to be that supplements are unregulated. Now you have Josh Sharfstein (formerly of FDA) quoted there saying that FDA has the tools it needs but they are hard to use."