Functional Fools & Enriched Evanescence

What if there was a clone of this world of nutraceuticals, an identical twin of the nutraceuticals industry, that existed in a different time/space dimension, where practices, choices and decisions could be played out differently than they are on this planet? What could a nutraceuticals business exec learn and extract, to infuse their brand with a proprietary, competitive edge?

By Anthony Almada

Inset: Do nutrition products enjoying branded product-specific safety and efficacy dossiers merit regulatory distinction?

Setting: Food and Dietary Supplement Administration (FDSA) press conference, rotunda of the National Hall of Regulations, Multiversity 2.c6.43; 20 March 2010

FDSA Commissioner Zeden: “Ladies and gentlemen, this is an august moment in the evolution of consumer health and education in this multiverse. For the past four decades, we have battled with marketers of nutritional products bearing unsubstantiated efficacy claims, or lacking any human safety data despite making express claims that the product was ‘safe and natural.’ Despite substantive budget increases during this period for our retail and online officers we can show only a modicum of success, defined mostly by enforcement activities performed in collaboration with other agencies.

“The food, beverage and dietary supplement landscape in this multiverse is often mischaracterized as unregulated, and perhaps more aptly, under-enforced. While the latter may be true, the former is reflective of gross ignorance or denial of existing regulations. The regulations on the books outline practices to adhere to, and a tacit disincentive for non-adherence. Simply stated, there is no reward for exceptional compliance and there are penalties for non-compliance.

“Almost 16 months ago we birthed ‘Project Victory,’ an internal, classified initiative with the objective of creating an ‘on label’ merit system for finished goods in the classes of foods, beverages, chewing gum and dietary supplements. Any finished good in any of these classes that has a safety and/or efficacy dossier meeting specific criteria would qualify for an FDSA seal on the product.

“The specific criteria have been the topic of intense internal debate. With today’s publication of the proposed rules, we are ushering in a partnered dialogue with industry in an effort to reshape and refine this on label merit system, called ‘Evidence First.’ It is our first attempt of several that will manifest over the next five years to fill the void that exists between drugs and nutritional products.

“A critical feature of the Evidence First program will be on- and off label claims monitoring of each certified product, on a random basis. This is to assure that recipients of the Evidence First seal are not abusing the meaning of the seal and that their claims remain limited to those substantiated in the dossier and allowed by the FDSA.”

Unidentified journalist: “Madame Commissioner Zeden, how will this program not harm the small enterprise or start up finished goods marketer, who would not likely be able to fund safety and/or efficacy studies in humans?”

FDSA Commissioner Zeden: “You raise a very good point. The cost of conducting clinical trials is not insignificant. However, free market and competition dynamics indicate that consumers would be very unlikely to buy only the Evidence First product, for a multitude of reasons. If we use our brethren on Earth as a comparison, only one antacid OTC drug product on the market has been shown to be superior to a placebo in humans. ALL of the other antacids lack clinical data of efficacy, and command the market share of sales. The lone product that does enjoy substantiation charges a premium price, and attracts the premium-seeking consumer who buys with confidence. This will work!”