When Congress passed the Dietary Supplement Heath & Education Act (DSHEA) in 1994, the intent was to give consumers the option to evaluate for themselves and make an informed choice about purchasing and consuming dietary supplements — or not. The legislation was meant to remove, or at least lower, the hurdle required for bona fide food ingredients about which the consumer may have no knowledge and thus no control over consuming. Congress intended to link “freedom of choice” with “personal responsibility.” A dietary supplement manufacturer would be held to lesser standards in demonstrating safety at the recommended label intake, i.e., “reasonable expectation of safety”; thus, the consumer would assume some risk, in that the basic long-term safety data would cast the consumer into playing the role of guinea pig.
The safety of an added food ingredient cannot rely on this level of uncertainty, as the general public does not make the decision to use or consume a novel texturizer, humectant, flavor modifier, or other processing aid. Because of the need for certainty that no harm will result from the unknowing consumption of a novel food additive, the FDA requires a “reasonable certainty of safety” be demonstrated via a food additive petition or a Generally Recognized As Safe (GRAS) determination.
In principle and in law (and from a common sense perspective — “accepting risk with choice”), there should be two tiers for safety. That is what the dietary supplement aficionados and purveyors wanted; that is what the FDA wanted (out from under the no-win safety decisions and gray-area bordering pharmaceutical efficacy decisions); and that is what Congress delivered. So after October 15, 1994, one would expect this to be non-contentious and smoothly running from all viewpoints.
Alas, this has not been the case. The FDA has not wanted to completely relinquish control. Fully 69% of submitted “New Dietary Ingredient Notifications” — the process whereby a manufacturer submits intent to market and documentation to the aforementioned “reasonable expectation of safety standard” — have been rejected by the Agency. On the other hand, some dietary supplement manufacturers have equated a lesser standard of safety with virtually no safety stand at all (lack of standardization, quality issues, lack of interest in current Good Manufacturing Practices, toxic contaminants, etc.). And the general public, the linchpin to DSHEA, has fallen into the philosophical trap “that if one is good, two must be better.” The unhappy result is that the Agency, Congress, and tort lawyers have become involved in the micromanagement of dietary supplement access (e.g., the demise of kava kava and ephedra).
Although counter-intuitive and surely counter-DSHEA, one attractive and successful opportunity does exist for the reputable dietary supplement manufacturer (or their ingredient supplier) to avoid this seeming morass of Agency rejections, medical community tarnish, civic watchdog scrutiny, FTC enforcement, public hysteria, Congressional meddling, and legal class actions. Simply, opt out of the lesser safety standard.
The FDA has shown it has only one definition of safety, so the distinction between “reasonable expectation” and “reasonable certainty” is without difference, i.e., the Agency expects the manufacturer to be certain. The GRAS process is available for dietary supplement ingredients, and although this process may require additional time and cost (to develop the required safety data to achieve “reasonable certainty”), it may in the long run be just the right ticket to avoid Agency gate-keeper decisions, demonstrate high-road corporate ethics to consumers, pacify public interest groups, muzzle media critics, deter tort lawyers, and be poised for the leap into functional food ingredients.
Part two to be continued in Dietary Supplements: A Special Case of Regulations.