EDITORIAL

Overruling the FDA

W e are hopeful that the results of the U.S. elections will yield positive effects for the nutritional supplement industry. There is little question that less regulation would kindle a victory for “freedom of choice,” a concept of great value for the success of nutritional formulations and what can be said about them. Allowing more health claims can spur a lot of health progress. Is this plausible? Recall that deregulation has been a major plank for the candidate that won the oval office.

Although we’re skeptical that the Federal Register—the main source of executive, rather than congressional, laws—is about to disappear, we can imagine that that FDA rule making would significantly dwindle. This is especially important with such potentially damaging items as the tyranny of “new dietary ingredient” rules, which the FDA is clamoring to pass into executive branch “law.”

Before 1994 and After

Until the passage of the Dietary Supplement Health and Education Act of 1994’s (DSHEA) amendments to the Food, Drug and Cosmetic Act (FD&C), dietary ingredients fit into two categories: grandfathered ingredients that were on the market before Oct. 15, 1994 (which was when DSHEA was enacted) and “new” ingredients that entered the market after this date.

The act stated that dietary supplements containing any new dietary ingredient (NDI) would be considered adulterated unless an NDI notification wasc filed with FDA 75 days before the NDI-containing product is marketed. All DSHEA said about this notification was that it had to demonstrate labeled or ordinary use of the ingredient is “reasonably expected to be safe.” This could be shown with a combination of history of use, scientific safety data and published research on the ingredient.

However, there was much confusion, especially among bureaucrats, about how this mandate should be applied, and the FDA misinterpreted “reasonably safe” to mean that such documents represent the agency's thinking or interpretation of the regulatory issue, but are not legally binding. FDA issued its first draft guidance on NDI notifications in September 1997, but the nutritional supplement industry noted this guidance merely restated the statute language and offered no clarity on the agency’s interpretation.

No Enforcement

The state of confusion would last for about another 14 years, during which FDA did not really enforce NDI regulations. Then, in July 2011, after consistent prodding from certain elements of the industry, the agency published an updated draft guidance that offered much more insight into its interpretation or intended policy on NDIs.

FDA Ignored the Original Intent of Congress on NDIs

The supplement industry reacted negatively to this draft, arguing forcefully that the draft ignored the original intent of Congress on NDIs. The draft included its shifting burden to companies to prove an ingredient was grandfathered with the FDA rejecting industry-supplied grandfathered lists that included affidavits. Worse yet, the draft ruled out synthetic versions of botanicals that are bio-identical. They also rejected ingredients that are chemically altered from their grandfathered state.

The industry argued that synthetics are not a safety issue and are used for practical reasons. The industry also said the FDAs thinking on their chemically altered position is too broad and would create undue burdens for ingredients that feature a new extraction method or other technological innovation.

A major surprise to the industry was the draft guidance's insistence that each dietary supplement containing an NDI must have its own notification, a stance considered the height of redundancy and excessive burden.

FDA seemed shocked at the swift and strong criticism of this draft guidance, and even Daniel Fabricant, PhD, the director of FDA’s Division of Dietary Supplement Programs, defended the guidance at many industry events in the year following its publication, and ultimately, FDA agreed in June 2012 to develop another draft guidance. But eventually Fabricant returned to the supplement industry from which he came, changed his mind, and now understands that the “new” rule is much like the old one.

The Deregulation Critics

Yet there is a lot of criticism launched against the new deregulatory regime, in which the new leaders can foster many significant changes in the regulatory sphere. Yet the deniers of nutritional sciences continue to advocate that:

  • Whole foods are always better than nutritional supplements
  • It is necessary to pass legislation to protect the sale of unproven nutritional supplements (they all are deficient in this regard)
  • All of the progress made during the heyday of the bureaucrats to “clean up” the industry and increase regulations and pressure on suppliers will go out the window and the market is going to be flooded with adulterated and low quality material.

Will the Trump presidency lead to that kind of a “disaster” for supplements, or will it be something else? Often, Trump has spoken about the excessiveness of the “Food Police,” in criticizing the FDA. Will his actions (through his appointees) lend themselves to more self-governance and consequently fewer targets for needless FDA enforcement?

Will freedom to forestall the FDA’s needless and costly rules allow the supplement industry to continue its rapid growth? With safeguards in place?

Putting a Brake on Regulation

“When we were speculating about what the world would look like with Hillary Clinton or Donald Trump as President, there was a general feeling that a Trump presidency would be against over-regulation, and against the idea of trying to legislate through guidance documents,” said Mike Greene, senior vice president of government relations of the Council for Responsible Nutrition in an interview with NutraIngredients-USA.* We hope so!


* Schultz H. ‘Pro business’ is best guess when looking at character of Trump administration. Nutra Ingredient-USA.com. November 9 2016. http://www.nutraingredients-usa.com/Regulation/Pro-business-is-best-guess-when-looking-at-character-of-Trump-administration. Accessed: December 4, 2016.


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