Editorial: Check the Baggage at the Door

By Len Monheit
[email protected]

Returning from the most recent Council for Responsible Nutrition Conference this week, I couldn't help but feel optimistic that there is a real regulatory opportunity emerging for the dietary supplements and natural products industry. And if, as the experts say, the 'space' is heating up with investor interest, then a solid regulatory framework with a platform of ongoing dialogue and communication with regulators should mean prosperous times for the sector.

I think this sense of buoyancy was shared by most who attended the presentation by Lester Crawford, Food and Drug Administration Acting Commissioner when he clearly stated his intention to "fully implement DSHEA". Yes, these are only words, and the actions will speak far louder, but the stream of messages coming from the FDA, especially their active participation and communication at industry events, seems to indicate that the people at the agency are intent on an active dialogue with industry and letting industry provide input at many steps along the way. Yes, the best rules and regulations often become disaster for lack of enforcement, but there is now some opportunity.

The words 'communication and co-operation' were used to describe the current environment with Crawford's stated goal "transparency, consistency and predictability". He committed to GMP's before year's end, and predicted a "blizzard of materials" which the agency will soon disseminate to get dialogue and discussion going. He committed that "every comment will be addressed" and that the agency's intention with respect to the industry and DSHEA is to, "satisfy the intent of the legislation" and that while it may need fixing, it needs at least to be tried. The agencies priorities, he noted, would be directed by risk-based practices - the higher the safety risk, the more urgent and active the FDA's actions. Dr. Crawford even went as far as to confirm that industry would certainly recognize the final supplement GMP's.

Good News but....

All of this should be extremely good news for the legitimate side of the industry, those who have been seeking clarity in the FDA's position and a commitment to taking industry input and actively enforcing DSHEA and its provisions as they now stand. This position and commitment demands, in its turn, several essential things from industry, that if not provided, will soon take the process and the opportunity literally 'off the rails'. and given past industry behavior, and even current signals, it's certainly not obvious or automatic that industry will give and get what it needs in order to secure the stable environment it requires.

As soon as Dr. Crawford mentioned the 'blizzard of materials' to be presented for comment, a buzz through the crowd began, with several people commenting on the likelihood of a deliberate attempt by the FDA to allow limited time to review materials before key discussion points, such as the November 15th session on New Dietary Ingredient notifications (http://www.cfsan.fda.gov/~lrd/fr041020.html ). Whether or not this is in fact the case is almost irrelevant, as anyone wanting input also has a responsibility - to look through any and all materials provided to participate as fully as they are able, and to actively and aggressively support those that do participate, such as the industry trade associations. It's been said before, there's probably not been a more important time to be part of a trade associations and all of them are going to be active in this dialogue and process. Failure to participate, means you abdicate responsibility for the outcome and what it might mean for your business.

'Ware the risks of fragmentation...

Past history in the industry would suggest that fragmentation is a serious problem, and even though evidence of trade association collaboration and communication is quite strong, (and the joint statement issued by the associations regarding the proposed GMP's might be the most important collaborative statement industry has ever produced) there is still a risk that their constituencies will force them to prioritize differently, excise certain products or ingredients from general consideration or in general, take a different view in their dialogue with regulatory agencies and cause confusion and mixed messages along the way. Now would be a very unfortunate time for industry fragmentation to impede a productive dialogue.

And don't forget to check the baggage...

Earlier this year, the World Anti-doping Agency (WADA) asked industry to work with it to better understand the issue of nutritional supplements in sport. One major industry trade association executive, likely voicing the opinion of several, dismissed this dialogue outright, citing WADA's past behavior, lack of communication and apparently malicious intent to vilify the supplements industry any time there was a doping scandal.

Industry has had, in recent years, both allies and opponents. While it must self-direct on the path to its objectives, and it must be wary of some opposition and even alternative agendas, it cannot go through the current dialogue and opportunities with the baggage of the last fifty years on its shoulders. The example above dismissed an opportunity to reach out beyond the world of the industry and establish a new relationship and new opportunity. Dialogue with regulators is exactly the same. They may have gone to the same school with similar influencers as previous regulators, but they are new people, in new circumstances - our current environment and reality. With all due respect, there are bigger 'fish to fry' and a progressive dialogue with the supplements industry will let FDA get on to more urgent issues.

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