The article, authored by Ranjani Starr, a Hawai-based public health official and recent PhD recipient, appeared in the journal Drug Testing and Analysis. Starr’s starting point is that, like tobacco back in the day, dietary supplements are insufficiently regulated at the federal level and state and local authorities can and should step up to the plate to put new laws in place. The author makes a circumstantial correlation between the dietary supplement industry and Big Tobacco: “Not much is known about the strategies used by the dietary supplement industry to protect its financial interests. The tobacco industry's strategies only became obvious when millions of pages of internal documents were released as part of the 1998 Master Settlement Agreement (MSA). . . While the tactics of the dietary supplement industry are not known, many superficial similarities to strategies used by industries who wish to avoid regulation and negative publicity are evident.”
Starr argues that the dietary supplement industry could plausibly use DSHEA, which she criticizes as “weak and ineffective” to build a federal preemption argument to invalidate any state or local laws that might seek to put new regulations around dietary supplements.
“The tobacco industry successfully preempted laws in 32 states, invalidating dozens of local laws and preventing hundreds of others from being passed. . . Dietary supplement advocates are well-versed in crying preemption; time and again, they have lobbied against the FDA's attempts to impose stricter regulations by arguing that the FDA's efforts contradict Congressional intent,” she wrote.
One of the basic premises of the article—that dietary supplements are insufficiently regulated—is a familiar refrain. But equating the way the industry seeks to make its case that the current regulatory structure is sufficient to the way the tobacco industry concealed the demonstrated links between its products and a host of diseases including lung cancer is new and has raised eyebrows to say the least.
“To equate the dietary supplement industry with the tobacco industry is reckless and disingenuous,” Doug Gansler, a partner in the law firm Buckey Sandler LLP and the former Maryland State Attorney General told NutraIngredients-USA. “Dietary supplements don’t kill people; tobacco does. If you smoke you are going to become addicted at at some point you are going to die. Hundreds of thousands of people die of lung cancer every year; with supplements there are millions of doses every year and only a few people have adverse reactions.”
Starr cites the research of prominent industry critic Dr Pieter Cohen of the Harvard Medical School at five points in her paper. Cohen has used this particular journal to publish a number of his papers citing what he has said is insufficient regulation of the industry. That connection was not lost on Loren Israelsen, president of the United Natural Products Alliance.
“This is the journal where Pieter Cohen and his colleagues publish a lot of their research. The objective is to lay out in a relatively minor journal like this their case for DSHEA reform and then use that to get attention in the press. What is alarming here and what has never been stated before is this equation of dietary supplements with the tobacco industry,” he said.
Israelsen said his organization opted for a low profile approach in responding to the article’s assertions, the judgement being that they were not rooted in fact.
“The gauntlet has been thrown down. Our response is to not take that up publicly. There is absolutely nothing here,” he said.
Attention grabbing move?
Israelsen noted that the author is from Hawaii, where a number of liver injury cases were reported in connection with OxyElite Pro, a product produced by USP Labs that contained aegeline, a substance that the Food and Drug Administration said was not a lawful dietary ingredient. That caused a legitimate concern in Hawaii, but Israelsen said UNPA believes that the wider purpose of the article was to get more state attorneys general interested in dietary supplements. Cohen, he noted, had made an appearance at a recent meeting of state AGs in St. Louis. Say “tobacco” and the interest of the AGs will be piqued, he said.
“The big tobacco settlements of the 80s and 90s profoundly changed the nature of the AG community. But to equate the issues of the dietary supplement industry with the ethics of big tobacco is scurrilous and utterly untrue,” he said.
Gansler said he wasn’t sure if that was the motive of the article; from his point of view the AGs already have the industry on their radars.
“What are the motives? To get the attention of the AGs? I don’t know. The state AGs already have the industry in their sights, and not necessarily because of something bad the industry might have done, but just because it’s a big business that affects a lot of their constituents,” he said.