Editorial: NNFA 2005: On Codex, CAFTA and Collaboration

By Len Monheit, NPIcenter

[email protected] Over the past several weeks, I have been involved in numerous industry events and discussions, and over the next several weeks I'll attempt to provide some thoughts and context.

At the NNFA annual show last week in Las Vegas for instance, I could not help but notice discussions which indicate a growing industry maturity, and then in stark contrast, discussion and dialogue bordering on blind panic, which did little but diffuse precious energy. In a general sense, I was struck by industry's buoyant optimism, although many at the manufacturer level were more than a little conservative as they continued to anticipate GMPs and waited for the next legislative 'shoe' to drop.

On the positive side, not for profit association AOAC International and over 20 industry executives participated in an intense several-hour dialogue over an issue that looms as a serious threat to trip up industry compliance with GMPs - the development and validation of analytical methods. It was observed that while scientists have been communicating and collaborating actively for years, executives had never met to discuss the issue and its implications or to discuss the need for a collaborative approach.

In a presentation to the group, AOAC Executive Director James Bradford noted other sectors and industries where AOAC had been able to assist and hoped that industry would actively participate in the method selection and validation process. Those in attendance got the message, I think, understanding that collaboration and input would certainly be required to accelerate the number of available methods beyond the twenty or so in the next five years currently supported by NIH funding. With hundreds, if not thousands of additional methods required in the very near future, resources will need to be deployed, and deployed effectively, so as to not waste funds and time. Bradford observed that the validation process takes upwards of $150,000 (perhaps as much as $250,000) in actual costs plus in-kind contributions (lab and personnel). Although the current quoted timeline was around 13 months or so for the complete AOAC process, AOAC had been working to reduce that time and for certain intermediate objectives, (developing a method that would assist in the identification of adulterated products with significant economic implications), a reasonable method (peer-reviewed agreed method) might be arrived at in a matter of a couple months or less.

Natrol CEO Elliott Balbert, voicing the thoughts of many of the CEO's in the room, asked about the economics of the process and requested information which could be incorporated into an actual business plan so that budgeting could occur. This comment pointed out that while no one in the room disagreed with the need for a streamlined and collaborative process for validation, the cost justification (even for guidance in assigning these costs on the financials) was a challenge. AOAC corporate membership is $10,000 per year, but placing this amount and any other contributions against an entire product range without defining method priorities seemed too loose a system for many in the room. On the other hand, Barry Titlow of Compound Solutions (who had championed the development process for co-Enzyme Q-10) noted that his contribution was targeted at that product, and it was justified on the basis of the cost of economic adulteration which would potentially destroy the marketplace for that product.

AOAC presented a list of current projects and status and asked for input into the priorities already identified, in addition to general or specific funding for acceleration, as well as the identification of personnel within these companies who could contribute or guide the process. AOAC, on the other hand, was asked to put the project scope into clearer financial terms that would make it easier for executives to understand the requirements and allocate funds.

Other issues:

On the minds and in the voices of many attending the show was the concept of CAFTA (Central American Free Trade Agreement), and of course discussion about recent international developments including Codex. Both were addressed in multiple presentations I attended.

CAFTA, if you ask the most fearful and paranoid, is either another government 'sell-out' or another feeble attempt at globalization in our industry. The agreement proposes to harmonize rules and regulations across the Central American region, and those most fearful expect supplement regulations to be harmonized as part of the process. Nothing could be further from the truth, according to both Attorney Scott Bass and to Iowa Senator Tom Harkin. Both noted that while CAFTA would seek to harmonize many classes of goods, the proposal could only affect laws in the categories specifically identified and that the supplements category was not listed anywhere in any of the proposed documents.

On codex, once again Bass (at an international reception) and Harkin (in a keynote address) sought to calm fears of the imminent demise of industry in the wake of the adoption of the Codex vitamin guidelines in Europe last week. Dealing with the issue head-on, Harkin firmly stated that US law would not change, and that these are voluntary guidelines and that they establish minimum levels rather than maximums.

Harkin's high energy presentation went further. In it he urged industry to kep up its communication efforts with Capitol Hill, noting that over 50% of legislators weren't around for DSHEA ten-plus years ago and even more (if not all0 of the staffers don't really know industry. The (latest) word on GMPs (or Gumps as he called them) is mid-September, and he urged industry to aggressively communicate to keep DHEA on the market as a 'beneficial supplement' which he uses himself. Harkin went on to speak about the FDA ("Fear and Denial Association" according to Harkin) which needs a non-biased commissioner and to help to change the way we look at healthcare and remove barriers for the supplements industry. He observed that we need to become a wellness society, getting in front of chronic illnesses. Harkin noted efforts at making supplements available using food-stamps, getting them into hospital regimens and providing more funds for supplements research. In closing he urged all within the industry to get legislators into stores and facilities to see industry in action.

NNFA 2005: Overall

Over the past several years, this event has been stabilized as a worthwhile event for some exhibitors and for those intent on discussing industry legislative and regulatory issues. The IADSA Annual General Meeting made available many key international figures to comment on global events, and with activity in Washington carefully communicated, those in attendance pretty much got what they expected. The show floor was decent day one and quiet day two, with few dramatic product introductions. Ayurceutics' Mangosteen continued to build momentum, several new water and beverage products were available, no immediate inheritor of the 'low carb' fad emerged clearly victorious, and significantly, an enhancement of pre-show label and product review ensured that the show floor was pretty much clear of embarrassing non-conforming product.

Unfortunately, the messaging being delivered at the booths themselves was not so enforceable.

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