The Raconteur & The Realist: For Whom Do The Bells Toll?

Taking a look at the state of flux as influenced by FDA, competitive tactics and a palpable tolerance of anecdotes and testimonials.

ByAnthony Almada, B.Sc., M. Sc.

On April Fool’s Day the FDA issued a series of warning letters in response to an e-commerce sweep of companies marketing weight loss products that were misbranded (due to the use of false and misleading advertising claims). Two ingredient classes exalted to the level of FDA scolding were chitosan and alpha-amylase in­hibitors derived from kidney bean (Phaseolus vulgaris), among both including a branded chitosan and a branded P. vulgaris extract present in a number of national, in-store (specialty and mass retail) brands. Many of the claims cited by FDA are not uncommonly used by a number of other, much larger marketing entities: “Product Y can substantially reduce the amount of fat absorbed from the foods you eat” and “Product Z helps to stop complex carbohydrates (starches) being broken down—as well as preventing glucose being converted to fat.”

The tectonic plate shifts in the weight loss market, engendered by FDA’s ban on ephedra-containing products, have elicited battle cries from a few lingering marketers of ephedra-containing products, who have professed to fight FDA in the courts. Claiming that FDA did not establish a convincing body of evidence linking adverse (and even lethal) events to the ingestion of such products, the plaintiffs will usher in potentially landmark court proceedings. From the other side of the fence a new generation of weight loss in­gredients borne of hope and very little evidence is attempting to mature, while some still clinging to the days of yore may be positioned to endure more intensive scrutiny and perhaps, regulatory restriction (e.g. phenolamine-containing extracts—Citrus aurantium—and pure entities e.g. octopamine).

A few years ago one of the primary architects of DSHEA told me that about 90% of the regulatory actions instituted by FDA were initiated by information provided by a competitor company of the alleged violator. This can be an effective, insidious and inexpensive means to injure or cripple one’s business rivals without necessarily revealing the behind-the-scenes orchestrator. What is an un­known variable is whether FDA will indeed act on such a “tip,” and at what speed. Nevertheless, from my vantage point this stealth competitive tactic appears to be increasing in frequency and ferocity but does behoove one to first have their own house resemble a biopharma clean room.

How do these three ostensibly in­congruent observations align? Since the inception of the dietary supplement “industry” a divide has existed: those on the “left” that believe and those on the “right” that disbelieve. This former movement, what I have long called nutritional evangelism, has in the past two decades been pulled into an amorphous midpoint, which may be dubbed evidence-based nutritional prophylactics and therapeutics. The latter movement, too, has “regressed” to the midpoint, pushed into recognizing the existence of an emerging and increasingly robust (but far from unequivocal) evidence base.

This body of science is striving to describe the prudent and informed use of nutraceuticals, even conventional foods, to achieve desirable outcomes in preventing the erosion of health and metabolic performance and arresting or even reversing the course of disease. One could argue that many more on the right are experiencing epiphanies, a road to Damascus-like enlightenment, imbuing them with a newfound perspective that acknowledges the left but is tempered with the demand for evidence still unique to the right. But how many on the left have gone to the “dark side.”

A few of my colleagues and I recurrently fantasize about the notion of jumping ship, inserting whistle in mouth, maximizing our lung capacity and becoming operatives for FDA and/or FTC. The emotional bond that prevents this is a desire to make even a modicum of difference from within left-center ranks, despite the disgust and intense gastric distress that accompanies the daily experience of a constant industry watcher. But why do we not cull the flock with a loud voice and a heavy hand? Where is the internal governing body that exiles the extremists to the proverbial Siberia? Why do we resist dedicating human and financial capital to true, preemptive and innovative research and development, not just search, duplicate, and sell? Why do we omit the negative and non-positive evidence that spoils our notions that all that we create is safe and effective? Surely if we continue to allow the left fringe and fundamentalists to coexist with those aspiring to the centrist position, resort to stealth and litigious tactics only in attempts to achieve greater economic gain, and allow the nutraceutical raconteur to prevail over the evidence-based realist, the entire regulatory landscape, and the proprietary and competitive edge advantage, may yield to wholly new forces.NWThe