Close observers of the dietary supplement industry have their pick of metaphors for describing the sector’s regulatory state-of-play: a jungle, a minefield, a game of whack-a-mole (or gotcha, if you happen to be one of the moles getting whacked). But given the current administration’s inclination toward relaxed regulating, is FDA as ready, able, and willing as ever to take action against supplement ingredients that arouse its suspicion?
As far as attorney Justin J. Prochnow, shareholder, Greenberg Traurig LLP (Denver), can tell, FDA’s eagerness doesn’t always translate into escalated enforcement. “FDA continues to take action against companies selling products with ingredients it believes to be dangerous,” Prochnow concedes. “But I don’t really believe it’s gotten any more heated than before.”
Why not? Chalk it up to the downstream effects of starving the bureaucratic beast. Years of funding and personnel cuts have turned FDA into what Prochnow calls “a pretty reactionary agency” that focuses on ingredients mainly after they capture public—and congressional—attention.
Case in point: In 2010, FDA took action against “the Four Lokos of the world”—namely, Charge Beverages Corp. (Portland, OR), New Century Brewing Co., LLC (Boston), United Brands Company Inc. (Los Angeles), and Phusion Projects LLC (Chicago), maker of Four Loko—for marketing caffeinated alcoholic beverages, “but only after college kids started going to the hospital and congressional representatives started raising issues,” Prochnow says.
“Then about four or five years ago,” he continues, “there was a focus on caffeine in energy drinks and supplements—again when Congress raised issues. And about a year or two ago, FDA sent out warning letters about picamilon”—a nootropic synthesized from niacin and gamma-aminobutyric acid—“after Missouri Senator Claire McCaskill raised issues.”
So with FDA’s enforcement seemingly contingent upon the volume of congressional outcry, it’s no wonder some brands “continue to push the envelope,” says Prochnow, “selling products with the next alternative to ingredients that FDA’s already questioned.”
Functional Foods the New Frontier
The trend has been especially evident in the functional food and beverage space, where a blurring of the boundary with supplements may encourage some brands to pursue ingredients that are common in the latter—activated charcoal, algae, and “medicinal” mushrooms like chaga, reishi, and cordyceps, Prochnow notes—but that aren’t generally recognized as safe (GRAS) for use in foods and beverages.
Yet despite this, “It’s a very rare occasion when FDA actually asks for GRAS confirmation from a brand owner,” Prochnow says. “This cues many companies to push the envelope and include ingredients for which there’s no previous evidence of GRAS. The result is more products on the market with questionable ingredients, leading more companies to think it’s okay to use those ingredients.”
To be fair, it isn’t always clear which ingredients companies can conclusively consider “okay.”
In the case of dietary supplements, a permissible ingredient must meet the definition of a “dietary ingredient” as spelled out in the Federal Food, Drug and Cosmetic Act—that is, it must be “a vitamin; mineral; herb or other botanical; amino acid; dietary substance for use by man to supplement the diet by increasing the total dietary intake; or a concentrate, metabolite, constituent, extract, or combination of the preceding substances.”
But some synthetic herbal and botanical extracts that would otherwise appear to meet these standards have caught FDA’s attention “because they were never actually constituents of the original plant,” Prochnow explains. And he’s noticed “some difference of opinion” among experts as to whether processing can turn a previously established dietary ingredient into a new dietary ingredient (NDI) for which FDA would require safety notification from the manufacturer before it could appear in a product.
For example, while bitter orange extract is an established dietary ingredient, a bitter orange extract that a manufacturer standardizes to 30% p-synephrine qualifies as an NDI because the amount of p-synephrine that occurs naturally in bitter orange is only about 6%, Prochnow says. “So the view of whether an ingredient requires an NDI notification or not may depend on whose view it is: FDA’s or the private brand owner’s.” (FDA released a revised NDI draft guidance in 2016, and though it falls short of settling all outstanding questions, it at least keeps the conversation going. Read our coverage on it here.)
“I would say the number-one thing FDA could do to make the line clearer is actually to take action and enforce issues like GRAS, or whether an ingredient is a dietary ingredient or not,” Prochnow concludes. “As mentioned, FDA’s regulation is somewhat sporadic and more reactionary than proactive. But tighter enforcement of GRAS and dietary ingredient requirements would result in a clearer demarcation between permissible and impermissible ingredients.”
Adds Sylvia Laman, managing toxicologist for dietary supplements, NSF International (Ann Arbor, MI), “Supplement brands should feel encouraged to reach out directly to FDA when they’re unsure about the regulatory status of a dietary ingredient. In addition, brands should collaborate with companies or individuals dedicated to substantiating the legal status and, more importantly, mitigating the risk associated with all ingredients used in product formulations.”
The Mouse Is Winning
For now, FDA’s hamstrung posture gives the mouse an advantage in this perennial cat-and-mouse chase. “The agency has limited resources and must therefore prioritize acting on consumer safety,” Prochnow says. “Thus, ingredients that might not technically be GRAS are unlikely to be challenged unless safety concerns are raised.”
Paradoxically, brands are as likely to face a challenge these days from commercial retailers like Whole Foods or Target—“both of whom are more vigilant than FDA about ensuring that ingredients are legally permissible,” Prochnow says—as they are from FDA proper.
So with uncertainty the only certainty, we asked the experts which ingredients have caught not just retailers’ and regulators’ eyes, but their own.
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