The FDA’s view that synthetic copies of botanical constituents are not dietary ingredients - and therefore not permitted in dietary supplements - is outlined in responses to citizen’s petitions and spelled out in its 2011 draft guidance on NDIs.
Its position - which has been roundly criticized as unscientific and unfair by the supplements trade - is one of the most controversial aspects of the guidance.
However, many stakeholders were hoping FDA officials might revisit this issue as they revise the guidance to reflect industry concerns.
FDA: A synthetic copy of a constituent or extract of an herb or other botanical is not a dietary ingredient
However, an FDA enforcement report flagging up the recall of sexual health supplements including Eroxil, Erosyn and Fertalin appears to put paid to that notion.
According to the FDA's July 18 enforcement report, Michigan-based H & L Jerch, Inc (doing business as Bell Lifestyle Products) has agreed to withdraw the above products voluntarily because they contain synthetic equivalents of spermine and/or spermidine, polyamines found naturally in oats and other foods.
The recall notice states by way of explanation that "a synthetic copy of a constituent or extract of an herb or other botanical is not a dietary ingredient, and such ingredients must be approved for use in supplements," and that the use "has not been approved."
The recalled products (which also contain selenium and vitamin B12) were developed by Canadian firm Nokomis Research, which claims to market “safe, naturally-based, effective therapeutics in the fertility and sexual health fields”.
NPA: We believe synthetic copies of botanical constituents can be dietary ingredients as long as they are safe
Cara Welch, Ph.D. senior vice president, scientific & regulatory affairs at the Natural Products Association (NPA) told NutraIngredients-USA that the FDA’s comment was “concerning” although not surprising.
She added: ”The NDI draft guidance isn’t the only place FDA has stated its opinion on synthetic copies of botanical constituents so this isn’t a surprising development in light of the recent announcements on the draft guidance but it is concerning, nonetheless.
“I’m not sure of the FDA’s plans for revisiting this topic but it’s a topic NPA has visited in the past and will revisit in the future.
“We believe that synthetic copies of botanical constituents can be dietary ingredients as long as they are safe so we’re watching the FDA’s enforcement tactics closely.”
Ullman: FDA position on synthetic botanical constituents is 'absolute nonsense, with no basis in science'
Speaking to NutraIngredients-USA.com when the draft guidance was published last year, Wes Siegner, a director at Washington DC-based legal firm Hyman, Phelps & McNamara, said the FDA’s stance was “lacking in scientific and legal merit”.
He added: “The FDA has voiced its views on this before, but the issue is nowhere near being resolved. This is going to shut off innovation.”
Speaking to us in February after a meeting with the FDA about the NDI draft guidance, Council for Responsible Nutrition (CRN) chief executive Steve Mister said there was room for compromise on several aspects of the guidance, but that the CRN was “not going to give on the synthetics issue”.
The FDA's stance on this issue, which Ullman, Shapiro & Ullman partner Marc Ullman has described as “absolute nonsense, with no basis in science”, has also been deemed “problematic” by the American Botanical Council.
Speaking to us last year, ABC executive director Mark Blumenthal said: “While ABC prefers to focus on natural plant materials, plant extracts, and plant-derived compounds, we are aware that some plant-based dietary ingredients are now produced - for the sake of cost and efficiency - via fermentation [for example].
“L-theanine may be an example, where the resulting ingredient made via fermentation is claimed to be chemically identical and, presumably, biologically similar or identical in action to the L-theanine found in green tea leaves.”
Nokomis Research: Attempting to work this out with the FDA
Nokomis Research told NutraIngredients-USA that it is "attempting to work this out with the FDA and get our products back on the shelf".
It also noted that "although a bio-identical formula is being used, it is 95% pure (USP grade, a purer form than natural extractions) and no different than the bio-identical vitamins put out by many vitamin producers whose products are still available over the counter".
An FDA spokesman said: "We must decline to respond with a direct answer to your question [about whether the FDA will revisit the synthetics issue in its revision of the NDI draft guidance] on the basis that the agency in general refrains from comment on what may or may not be included in future rules and guidances."