By Len Monheit
Yesterday, the US FDA announced three new initiatives to fully implement the Dietary Supplement Health and Education Act of 1994. The initiatives, hinted at in a speech by Acting Commissioner Dr. Lester Crawford at the annual Council for Responsible Nutrition (CRN) Conference last week are theoretically intended to create "transparency, consistency and predictability" and perhaps most importantly, an ongoing dialogue with industry and trust with consumers. The outcome, while not likely creating absolute black and white, could effectively reduce the 'gray zone' of misunderstanding and misconceptions surrounding dietary supplements.
Reading the primary documents, the logic of the presentation and FDA's intentions become quite clear.
- Regulatory Strategy for the Further Implementation and Enforcement of DSHEA (http://www.cfsan.fda.gov/~dms/ds3strat.html)
- Notice of Dietary Supplement Public Meeting: Pre-Market Notification Program for New Dietary Ingredients (http://www.cfsan.fda.gov/~dms/ds-ndi.html)
- Guidance for Industry Substantiation for Dietary Supplement Claims (http://www.cfsan.fda.gov/~dms/dsclmgui.html)
Those familiar with DSHEA will likely find no faults with any intention expressed in these documents. They may question the practicality of some of the approaches (specifically - enforcement and product testing), and they may disagree with the standards FDA starts to lay out in its Guidance Document on claims substantiation and the standards FDA seems to be expressing.
For those who haven't yet had time to read the 'blizzard of correspondence', the focus is on New Dietary Ingredients and pre-market authorization requirement for these (subject of a November 15th public meeting), GMP's including the final rule, outreach, implementation and enforcement activities including an 'active inspection and compliance program', examination of product labeling and claims, especially 'unsubstantiated structure/function claims', with the stated intention to "identify and take enforcement action against products whose labeling fails to reveal material facts, targeting those products that pose the greatest risks to consumers", to "obtain and analyze samples of dietary supplements in the marketplace to verify that the contents are consistent with the labeling" and to "move beyond its current focus on products identified on the Internet and more closely scrutinize products in the marketplace."
Since the announcement was issued yesterday, we've seen extensive media pickup, mostly citing an article which appeared in the Washington Post (http://www.msnbc.msn.com/id/6412049/). The headlines of this story have changed frequently, continuing to show industry's battle with misconceptions and a hostile media:
- 'FDA unveils new rules for supplement labels' - High-profile cases put pressure on agency to use its authority
- 'FDA sets up system to ID dangerous supplements'
- 'FDA outlines system of dietary drug regulation'
Even if the media doesn't fully comprehend the current environment, let's hope that industry clearly understands what is at stake with these initiatives and the response we show. At press time today, we had observed two formal industry responses, AHPA and Natrol . While it is unfortunate that the media climate makes such responses necessary, personally I'd like to see a 'blizzard' of responses from all industry-leading companies saying they eagerly look forward to working with the FDA and are working towards the same objectives as FDA - themselves, and as an industry.
Reading the 'draft guidance' on claim substantiation was an experience. Most impactful was the inclusion of twenty-one examples including FDA's logic and 'likely' interpretation of the level of substantiation.
Following are a few examples: (http://www.cfsan.fda.gov/~dms/dsclmgui.html)
Example 9: A firm is marketing a product specifically to reduce nervousness during stressful everyday situations, such as public speaking. The firm has results from several small studies demonstrating that the product will raise blood levels of a chemical that is well known to relax people in stressful situations. The firm also has two small, randomized, placebo-controlled studies showing that its product positively affected measurable indices of anxiety in people placed in stressful situations, including public speaking. These studies may be adequate evidence to support the product claims. Although the studies may be small in terms of the numbers of subjects tested, they are well-designed studies that resulted in statistically significant positive results that are consistent with the larger body of scientific evidence related to stress anxiety in public situations.
Example 13: A dietary supplement claim states, "Data suggest that including Substance X in the diet may promote brain neuron health in healthy individuals." The firm cites a study in which rats were fed diets containing Substance X and the brains of all rats were examined for ischemia-induced brain damage. The study does not provide a basis that Substance X would have the same effect on brain health in otherwise healthy humans. This study alone likely would not provide adequate substantiation of the claim being made because it relies solely on animal data.
Example 16: A botanical product label uses the claim "improves vitality." The substantiation that the firm is relying upon consists of testimonial experience it has collected from consumers and descriptions of the botanical product's traditional use. Although the firm may have testimonial experience to back up the basic claim being made, the claimed benefit would likely not be adequately substantiated because neither source is based on scientific evidence. If the firm wants to make a claim of this type, we recommend that it have scientific evidence that some measurable outcome(s) associated with the general conditions cited in the claim is (are) significantly improved.
We've probably all seen examples of abuse of structure function claims, and a higher awareness and a finished guidance document, supported by solid, consistent enforcement on the part of the FDA would be welcome. with New dietary Ingredients, presumably the public meeting will be the next of an ongoing round of discussions that identifies, among other things, how ingredient equivalence is established, and what level of manipulation and processing actually creates a new ingredient, and hence a new NDI requirement.
As these initiatives play out and the rules get understood, it should become easier for regulatory agencies, us, media and consumers to identify the companies that are playing by the rules and those that are not. And that, certainly, is a good thing.