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Editorial: Fundamental Principles

By Len Monheit

The past several weeks have been anything but boring. Let’s take a quick look at a few recent developments and how they underscore key principles and behaviors that will either underpin or erode our industry.

The tainted pet food issue has evolved into a major question on food safety with implications that the US Food and Drug Administration (FDA) does not have adequate power or resources to protect the food supply. A story which began with pet foods, now involves an escalation into general foods (including supplements) especially where complicated sourcing implications make traceability and accountability a challenge, if not an impossibility. (The implications for our value chain are pretty obvious.) Rather than focus on a particular geographic region, the practices in our industry, rather than the region, should make this a concern for just about anyone. So an overhaul, or at least a rethinking of food safety legislation has become a national and to certain extent global priority, especially since international trade is certainly the most problematic to control at national levels.

And we move to SupplySide East, where certainly the melamine (pet food) issue dominated much of the conversation, even as attendees aggressively examined the wares of many international vendors on the show floor. Those suppliers with limited or no affiliation with offshore vendors licked their chops in the belief that purchasing agents would quickly alter sourcing practice, denying the reality of the economic drivers that are a real underpinning of our value chain. An unfortunate reality yet to be dealt with is that it will likely take even more pressure and enforcement (and yes legislation) to change some of the buying practices which drive the highest quality ingredient manufacturers to such levels of frustration. Also, while the finger can be readily pointed at international suppliers, perhaps largely in China and India, when quality is not fundamentally entrenched (and valued) in sourcing practices, even a North American source can be questioned. So while ultimately this exposure of spiking activity might lead to more of a quality focus, the short to mid-term reality is that spiking has been an issue in this industry for years, will not cease overnight, and the “see no evil, speak no evil, hear no evil” mentality will not disappear. Currently, the risk:reward ratio is flawed, and until that changes, many companies will not drastically alter buying practices to those that might change their current bottom line. One might hope though, that at least some will begin checking incoming raw materials for the most obvious adulterants, recognizing that just as they are motivated to manage their bottom line, so too are some short-sighted ingredient manufacturers currently also benefiting from the flawed risk:reward environment.

And GMPs are on their way...

At last, and after many years, US Good Manufacturing Practices for dietary supplements are on their way. In about five weeks, according to a press release from the office of Senator Orrin Hatch, one of the fundamental provisions of DSHEA will come into effect, with the promulgation of a final GMP rule. It is not known how significantly this rule will differ from the one proposed several years ago, and whether efforts by the Office of Management and Budget to make it more ‘appropriate’ for small and mid-size businesses, but the mere promulgation of the bill will not have any immediate effect on business activities. Sure, we’ll see company after company step to the line claiming immediate compliance, we’ll see active education by industry trade associations on the implications of the bill, but by and large, good companies will continue to operate as they have, and those more unscrupulous will continue to operate as they have too, denying to change anything until forced to by the risk:reward ration noted earlier. Although it still remains to be seen, the principle of ingredient quality (obviously leading to effectiveness of the products) might not be prescribed in the regulation. Since specifications are determined by manufacturers and presumably ingredients sources and tested to meet these specifications, if there is a disconnect or gap between the manufacturers specifications and those that determine absolute quality, (ie. specific extract determined in peer-reviewed study to be associated with efficacy, or ingredient determined not to contain potential economic adulterants in addition to general impurities associated with safety) then there is a fundamental flaw, unaddressed by the regulations, that industry must resolve itself.

And finally...

The Natural Health Products Research Society (NHPRS) of Canada held its 4th annual meeting this past week, in conjunction with the Canadian Herb, Spice and Natural Health Products Coalition. Although the designation is ‘Canada’ the event actually has significant international context, and this year’s event was no exception with significant input, especially from the United States with a solid presence by the American Herbal Products Association (AHPA) the United Natural Products Association (UNPA) a scientific presentation by the Council for Responsible Nutrition (CRN), contributions by The Office of Dietary Supplements, NIH, and other activities and representation, national and international.

The four day symposium had some 33 sessions ranging from non-timber forest products to product quality standards for basic and clinical research, novel processing strategies to biotechnology tools for natural health products.

Some of the hard-hitting, far reaching messages delivered during the event:

“Every study is a safety study” (Dr. Mary Hardy MD, Director, Integrative Medicine Group, Cedars Sinai Medical Center; Associate Director, UCLA Center for Dietary Supplement Research in Botanicals)

The opportunity to collect and organize safety information through the clinical research process is huge. Building this safety denominator helps support the body of evidence which is determining that natural and health products and supplements are much safer, by and large, than other health treatment options.

The importance of qualifying research materials (in a standardized fashion) (factor in several presentations)

Past trials have been non-reproducible, results have been challenging to interpret, and when studies do not succeed, the investigation to determine why the result is at odds with previous research has been made more challenging, if not impossible. Efforts to raise the bar amongst the research community in presenting full qualifying details regarding the materials used in their research was identified as a major priority.

The link between science and marketing (or rather the gaps therein):

This is obviously a subject that justifies an editorial or two all its own. In short though, the symposium this past week reinforced the need for communication regularly between the research community and industry as a whole, and that often, the marketing message loses its grounding with the state of the science. In partial defense of the marketers, sometimes this is driven by the desire for simplicity. Often though, this is driven by the urge to sensationalize and take out of context the original research. On the flip side, frequently the research community is pretty naïve about business and market reality, and so this gap must be closed to allow efficacious supplements, NHPs, functional foods and beverages to be available to consumers and to reach optimum market and health impact potential.

These four events and developments listed above are all connected. The principles of commitment to quality and integrity in all practices underlie each. Our collective mission should be to reward those companies, business professionals and the researchers and institutions exhibiting these principles.

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