In comments filed on the public docket in December, Jarrow, which manufactures a wide array of dietary supplements, took the Food and Drug Administration to task for many instances in the draft guidance which the company said went far beyond the scope of the Dietary Supplement Health and Education Act (DSHEA) and which ran counter to that legislation’s intent. Jarrow said the updated guidance, which was filed in July and was a reissue of the first draft guidance from 2011, did fix some of the problems with the first go round. But one thing that was not fixed, and in fact was made worse, is an inappropriate attempt to apply food additive safety guidelines to dietary supplements.
Food additive standard inappropriate
“This Guidance is still an attempt to apply stringent food additive safety standards to dietary supplements when DSHEA specifically excludes supplements from this category. The Agency's unfounded application of a food additive petition safety standard to supplements not only disregards the law, but also ignores the remarkable safety record of supplements vis-à-vis other FDA regulated products. In other words, there was and is no need for many of the new definitions and new tests required by this Guidance,” the company’s comments said.
Jarrow’s underlying theme is that the guidance as it stands undermines DSHEA. The guidance would result in many existing dietary ingredients being judged as “new” because of an overly expansive view of what constitutes “chemical alteration.”
“While purporting to ‘clarify’ DSHEA, the Guidance in truth contravenes DSHEA, unlawfully setting forth an overly expansive definition for the term NDI that would cause many dietary ingredients already in the marketplace and safely consumed for many years, even decades, to be considered ‘adulterated.’ The Guidance is an unabashed attempt to subvert existing law and regulation,” Jarrow’s comments stated.
For example, the guidance mentions that processes that would constitute chemical alteration include the use of solvents other than ethanol or water, and the sue of new techniques such as supercritical CO2 extraction. Jarrow’s comments label this view as a “19th Century nature cult anachronism” and notes that other solvents, such as hexane and acetone, had been used safety prior to the passage of DSHEA. It also noted that supercritical CO2 has been used for years in the food industry without incident.
“These restrictions would prohibit dietary supplements from using the very same methods utilized by the conventional food industry to extract food oils from seeds, peanuts, soybeans, and other sources,” the comments stated.
Synthetic botanicals
Jarrow’s comments also take FDA to task for its dim view of synthetic copies of botanical constituents. The draft guidance states that since these synthetically produced molecules were at no time resident in a plant, they do not qualify as legal dietary ingredients. Jarrow’s point of view is that these should fall under the definition in DSHEA of a "dietary substance for use by man to supplement the diet by increasing the total dietary intake.”And the company’s comments go further to state that synthetic ingredients, such as certain vitamins and CoQ10, have already been in the market for years, so it is illogical and inconsistent to single out this one category of synthetic ingredients. And the technology offers potentially powerful benefits.
“Synthetic botanicals also overcome seasonal availability problems, heavy metals and pesticide contamination, and protect threatened species. Since GMPs require consistency, reliability, and predictability, this is a technology that can be desirable. It is also likely that this additional provision—found nowhere in the law—would constitute a prohibition of tissue culture fermentation technology,” Jarrow’s comments state.
Economic impact assessment lacking
Jarrow’s comments note that the 2016 draft guidance includes no assessment of the potential economic impact of its provisions. This would be severe, the company maintains.
“Turning what Congress intended to be a merely notification system on its head, the Guidance in essence seeks to establish a harsh pre-approval system for supplements, imposing a significant and unnecessary financial and logistical burden that most supplement manufacturers could never meet,” the comments state.