One of the predictable takeaways of last week’s annual CRN conference was the opportunity to interact with regulatory leaders to gauge their priorities related to the industry, and to assess, what, if anything, industry should specifically and immediately do to prevent legislative catastrophe.
Ever since Congressman Waxman published his book, “The Waxman Report: How Congress Really Works”, (actually even before it) rumor has abounded that a new attack on DSHEA was imminent. With several key associates in prominent positions, it was argued, it was only a matter of time before an outright attack would occur, likely with pressure from a number of places, and the appointment of Dr. Joshua Sharfstein, as Principal Deputy Commissioner of the US Food and Drug Administration (FDA) was one such potential trigger. So it was with a lot of interest that I awaited Dr. Sharfstein’s CRN presentation at Terranea Resort in Southern California last week.
Frankly, it didn’t start too well, with Exhibit A being anabolic steroids, including comments made a few weeks ago by USADA at the hearing of the Senate Judiciary Committee, noting the use of steroids, marketed as supplements or supplements contaminated with steroids. To quote Dr. Sharfstein: “The steroid problem is the most high profile safety issue facing the nation’s supplement supply.” For those in the supplements industry who in the past have failed to recognize the link between the future of supplements and the sports community, I sincerely hope the period of gross naiveté is over. Dr. Sharfstein noted, “People can hear these stories and believe that the entire supply of supplements is tainted.”
Although one of the industry associations had suggested that FDA use the same grounds it is aggressively using to thwart claims related to H1N1, Dr. Sharfstein noted that this case was different as with sports products, there may be inadequate evidence to prove the claim is unsubstantiated and misleading and proof of contamination or illegality would require testing. In this area, Dr. Sharfstein suggested new tools may be required, as has been recommended by various groups including USADA.
The mood got a bit better as Dr. Sharfstein recognized this as an outlier issue, and consistently noted that working with industry, and using all the tools provided for by DSHEA, was a priority for the agency. On that subject and next up, and the topic for a lot of industry speculation in recent years, was new dietary ingredients or NDIs. First of all, industry has been clamoring for a guideline for years. Industry has also submitted a list of what it classifies grandfathered (2004 and prior) ingredients (ODIs or old dietary ingredients), although FDA has refused to acknowledge that list. That point was emphasized by Sharfstein, “we have been hampered by the fact that no verified list of grandfathered ingredients exists.” In order to prepare that list, FDA will be looking for documentation proving an ingredient was in commerce prior to October 1994. Note to industry: if you think you’ve got a borderline case, get searching your files for proof. Future guidance will prove both interesting and controversial. At least industry and FDA both agree it’s a priority, and the fate of ingredients such as hoodia and resveratrol could both rest on the ensuing dialogue.
The full text of Sharfstein’s speech is posted here, although some might argue that the real substance of the presentation was in the post-presentation Q and A and key takeaways.
In his actual presentation, Sharfstein commented on new tool requirements, specifically speaking about steroid-laced products. In the Q and A, he was specifically asked whether DSHEA provided enough tools or new tools would be required. In short his answer was to attempt to “use all the tools provided for within DSHEA, but I can’t say that it is enough.” Both parties (industry and FDA) have to be open to a discussion of new tools.
An interesting discussion regarding heparin also ensued. This issue dealt with source contamination, pointing out the focus on supply chain issues in quality management and ultimately GMPs. While Sharfstein pointed out that in the food world, the Reportable Food Registry was a mandatory destination for known quality issues, he suggested that something ‘like that’ be established on a voluntary basis for known supplement adulteration or contamination cases. Specifically, his call was to ‘let us (FDA) know’. Using the example of heparin may be significant. A few weeks earlier, an FDA official, in a one on one conversation, observed anew the relationship between contaminated heparin and chondroitin sulfate, querying whether there was a potential supplement industry quality issue to investigate.
The Q and A with Sharfstein quickly turned to the recent Hydroxycut recall. Obviously an industry and audience hot button, Sharfstein pointed out that in this case with what he termed idiosyncratic liver damage, zero SAERs becomes the only acceptable amount (as it would be for drugs and OTC products). When asked about what, if any of the ingredients were the trigger ingredient, Sharfstein couldn’t say and noted that FDA couldn’t really even speculate in the absence of more information. He did call upon responsible industry, in the future to, in this type of case, share whatever information it could internally and with the agency.
On the subject of international regulatory agencies and developments, Sharfstein noted that there is an ongoing and active dialogue, specifically noting Australia and the EU. He referred to the development of a strategy for regulations with those countries with ‘more developed regulations’. In closing the Q and A, Sharfstein once again reiterated the priorities were using undeveloped tools such as NDIs and GMPs and working where possible, collaboratively with industry and associations.
Some Key Takeaways:
• Spirit of collaboration,
• NDIs are the number one priority,
• DSHEA may provide but most likely does not provide adequate tools to take care of all issues, and
• Adulteration and other terms are consistently being replaced with the far more damaging term ‘contamination’.