Back in 1994, who could have predicted how the Internet would impact the way we receive information? Whether it’s getting the latest sports scores, finding a restaurant in a new city or searching out customer feedback on a washing machine, we turn to the Internet for just about everything. That includes getting information about our dietary supplements.
The problem is the Dietary Supplement Health and Education Act (DSHEA) didn’t contemplate a world in which virtually all information is available on a laptop, iPad or smartphone. It didn’t imagine that we could walk the aisle of a health food or drug store and check a manufacturer’s website to see how the product is made, search out the latest research on a nutrient or compare prices with other retailers. When DSHEA was negotiated, no one conceived that the worldwide web would allow consumers to access scientific research with just a few clicks to examine the evidence base for a particular ingredient and its ability to prevent or treat diseases.
Marketers of dietary supplements and their ingredients now have to navigate this brave new world with tools that were created for a different era, when branded marketers primarily talked to their consumers through traditional advertising. In particular, the “third-party literature” provisions in DSHEA that were intended to allow retailers to share limited information with their customers are as obsolete as your VCR.
Looking Back
This section of DSHEA expressly permits retailers to distribute scientific literature about their dietary supplements under very specific conditions. It permits brick and mortar stores to maintain a separate physical section of the store in which to provide scientific studies to customers without running afoul of the prohibition that dietary supplements can’t mention diseases. Retailers may offer customers published studies that discuss disease-related uses for the products provided these publications do not promote a particular manufacturer or brand; the literature section must be “physically separate” from the dietary supplements for sale; and the publications cannot be “appended” to specific product information. These publications may include an article or scientific study, a chapter in a book, or an official abstract of a peer-reviewed scientific publication that appears in an article, and the article must be reprinted in its entirety. The provision brings to mind the image of a health food store owner cranking out photocopies of journal articles and distributing them in a separate “reading room” of the store.
At the time, this provision was no small concession. Recall that the “bargain” industry made back in 1994 was that dietary supplements would not be labeled to treat, prevent, cure or mitigate any disease; supplements would need to stick to describing their nutrient content and more generalized claims about health and wellness called “structure/function claims.” The third-party literature provision was the one exception—over FDA’s objection. Science was already pointing to the ability of certain nutrients and herbals to help combat disease; but the industry conceded to Congress in the ‘94 law that those who stood to profit from the sale of dietary supplements (e.g., manufacturers, marketers and retailers) would be prohibited from discussing the disease-fighting abilities of these products in advertising. To do so, would make the product a “drug.”
DSHEA in the New Age
Today, with instant Internet access to all kinds of information, maybe it’s time to renegotiate the third-party literature portion of that bargain. The dilemma for marketers has been how to educate consumers about the disease-fighting benefits of dietary ingredients. If they promote the research on their websites, or post the journal articles reporting the studies, they risk a notice from FDA that the study evidences their intent to market the supplement as a drug. Some companies are getting creative by developing “research libraries” on a separate website from where they promote their products. But maybe it’s time to recognize that in this Internet age, consumers have a right to locate scientific research about dietary supplements and evaluate it for themselves—without being told the product is an illegally marketed drug.
Research on dietary supplements for therapeutic endpoints has grown tremendously, with academic researchers getting into the game—which often means they, and not the manufacturers, decide how to create the study, conduct their research and report the outcomes. In the publish-or-perish world of academia, they would much rather study a substance for potential disease endpoints than investigate a substance’s ability to promote good health. When they publish that research, manufacturers should be able to point consumers to it, even if it suggests disease-related uses for the ingredient, and even if the results are not permitted in labels or advertising.
In the past year, several courts have upheld the First Amendment right of consumers to receive, and of marketers to make, so-called “off label” claims for prescription drugs. These are claims FDA has not specifically approved for those products, but for which substantial research exists. It seems to me that Congress would be sympathetic to similar arguments for revisiting the “third-party literature” provisions of DSHEA. If peer-reviewed studies have examined potential preventative or treatment effects of dietary supplements, shouldn’t consumers be able to access that information and make informed decisions about their healthcare, even if the website or link is provided by a company who stands to profit from making that information available?
Recently industry has been discussing possible changes to DSHEA to allow FDA more transparency into the industry. It seems to me that any serious negotiation about amending the law should include a
conversation about revising the third-party literature provision, too. It’s time to bring it out of antiquity and permit online access to the science that supports the myriad uses of dietary supplements, even when that research discusses preventing, treating or curing a disease.WFSteve Mister is the President/CEO of the Council for Responsible Nutrition (CRN), the leading trade association for the dietary supplement and functional food industry.
Published in WholeFoods Magazine, October 2015
