“While better federal oversight for dietary supplements remains essential, states may also proactively engage in regulatory activities to minimize harm from dietary supplements to their citizens,” writes Ranjani Starr from the Department of Public Health Sciences at the University of Hawaii at Manoa in the journal Drug Testing and Analysis.
“States interested in pursuing dietary supplement regulation may benefit from the experience gained in regulating other substances known to pose a risk to the public. For example, substantial progress has been made in the regulation of tobacco use at state and local level. Strategies and lessons learned from tobacco regulation efforts may be used to help states decide what to regulate and how to effectively overcome regulatory hurdles.”
[Starr previously authored the article, “Too Little, Too Late: Ineffective Regulation of Dietary Supplements in the United States” published in the American Journal of Public Health (March 2015, Vol. 105, pp. 478-485).]
To support the link with the tobacco industry, Starr goes on to discuss industry lobbying efforts, noting that the industry spent $4 million on lobbying in 2014. The author also notes the tactics employed by the tobacco industry to fund research to support its position, and to suppress research that showed the risks of smoking.
“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,” wrote Starr.
Dr Daniel Fabricant, Executive Director and CEO of the Natural Products Association, called the comparison with Big Tobacco “bananas”.
“But I think it is good for the industry to see that comparison and realize how important it is to be involved in DC and at the State level,” he said.
The timing of the paper is interesting given the actions this year by NY Attorney General Eric Schneiderman and other Attorneys General. The AGs have not only been responsible for enforcement actions in their own state (New York in particular), but 14 of them wrote to Congress requesting greater federal oversight of supplements in April.
“Much like the groundswell of anti-tobacco efforts that helped organize the public health movement in support of tobacco policy, ‘safe supplement’ supporters need to coalesce, at local, state and/or national level, to develop a well-organized approach to achieving better regulation of dietary supplements,” wrote Starr.
“The recently formed coalition of 14 state AGs that promises greater oversight of the dietary supplement industry is indeed an important step in the right direction.”
Loren Israelsen, President of the United Natural Products Alliance, told us that he was deeply concerned by what he read. “The analogy of dietary supplements to the tobacco industry is a provocation,” he said.
“For Attorneys General, taking on the tobacco industry was a landmark in their history. So, to now suggest that there are similar behaviors, budgets, deceptive practices in the dietary supplement industry is utterly over the top. I am beyond disappointed to see a public health expert have this view.
“I’m also deeply concerned that this view will be widely repeated, and urgent action is needed by the industry. At the same time, I don’t want to give more legitimacy to this by over-reacting. But it is an utterly false premise.”
The need for engagement
NPA’s Dr Fabricant told us that there is an assumption by industry critics that the pre-market approval model used for pharmaceuticals is ironclad. “That is just not accurate,” he said.
“This is a hot media issue right now and you have 50% of Americans taking supplements, so in the eyes of the media 50% don’t, and they’re portraying this us-against-them image,” said Dr Fabricant.
“We need to engage politically and with the media to ensure they get accurate information.”
Also published in Drug Testing and Analysis is an article by John Swann from the History Office, Office of Communications, Office of External Affairs, Office of the Commissioner, FDA, called “The history of efforts to regulate dietary supplements in the USA”, which documents the regulation of supplements from 1906 to today.
“Stiff resistance to the regulations by supplement manufacturers, trade associations, politicians, and especially the public at large is an important part of this story,” write Swann.
“[G]iven the chequered past with efforts to regulate dietary supplements, it is all the more important to learn about the problems that have been encountered with some of these products […] As regulatory history has taught us with so many other commodities, the problems we faced often helped stimulate improvements in public health.”
Both papers are available as open access articles by clicking on the following links below:
R. Starr, “Should states and local governments regulate dietary supplements?”, doi: 10.1002/dta.1926
J.P. Swann, “The history of efforts to regulate dietary supplements in the USA”, doi: 10.1002/dta.1919
The papers are part of a special issue of Drug Testing and Analysis, which includes the articles listed below:
Breaking the gridlock: Regulation of dietary supplements in the United States
Hepatotoxicity associated with the dietary supplement OxyELITE Pro™ — Hawaii, 2013
Adulterated dietary supplements threaten the health and sporting career of up-and-coming young athletes
Consumers' perceptions of the dietary supplement health and education act: implications and recommendations
Self-reported side-effects associated with use of dietary supplements in an armed forces population
History full circle: ‘Novel’ sympathomimetics in supplements
Dietary supplements: What's in a name? What's in the bottle?