Major dietary supplement industry trade associations used up all the ink in their red pens while reading through the draft guidance on New Dietary Ingredients and all came to the same conclusion: It’s time to throw it out and start over.
The Food and Drug Administration extended the deadline for public comment on the draft—first issued in early July—to Dec. 2. Comments from the Natural Products Association (NPA), the Council for Responsible Nutrition (CRN) and the American Herbal Products Association (AHPA) and the United Natural Products Alliance (UNPA) all call for outright withdrawal.
And the issue of withdrawal is important. The tendency is for federal regulatory agencies (not just FDA) to use language in draft guidances as the basis for enforcement while the possibly lengthy process of reviewing comments and discussing revisions proceeds. This is why lawmakers and members of affected industries are so unhappy when a guidance document strays so far from the spirit of the statute it is supposed to explain, as most observers agree the NDI draft guidance has done.
“Industry needs some clarity in the short term so that they understand that this document is not going to be used as the basis of enforcement,” said Steve Mister, president and CEO of the Natural Products Association.
The ink was hardly dry on the last of the comments as this article was going to press (AHPA, for example, filed its 70-plus pages worth of comments minutes before the clock struck midnight on Dec. 2) so reaction from FDA was unavailable, and in any case, the agency has several hundred pages of comments to read through and to file before responding. But there has been a series of give-and-take sessions between Daniel Fabricant, Ph.D., director of FDA’s Division of Dietary Supplement Programs, and industry leaders over the course of the summer and fall, so it’s likely the agency already knew the broad outlines of what was coming.
Problem 1: unlawful rulemaking
Two issues lie at the core of the objections raised by industry. The guidance is overly broad, and strays from the language of the Dietary Supplements Health and Education Act (DSHEA) in such a way that it constitutes an unlawful “rulemaking by guidance.” The Administrative Procedures Act gives regulatory bodies the authority to write rules that might greatly expand upon, or even contravene, portions of an underlying statute. The idea is that laws are by their nature imperfect, and subsequent experience in a regulatory setting might show the underlying law is incomplete, or just plain wrong. But alterations of this nature must be done via a formal rulemaking, which would include Congressional input and which can be challenged in court, giving the affected industry some manner of redress. If FDA really wants all of the things in the NDI draft guidance, it should start the process of writing a formal rule, industry is saying.
One of the key areas in which the guidance strays is in the level of safety data it requires. All the comments agree that the draft guidance is applying a food additive level of safety. DSHEA was specifically intended to put supplements in a category distinct from foods. Food additives are tested to meet a standard so that they are “reasonably certain to be safe.” It’s a higher bar, meant to apply to substances that could appear in many daily servings of food consumed by all segments of the population. Supplement ingredients, on the other hand, are tested to meet a “reasonable expectation of safety,” appropriate to ingredients that can be targeted to certain populations (excluding, for example, infants and pregnant women) and which would be consumed in only one or several daily servings. The draft guidance inappropriately shoves supplements toward the food category.
It’s about ingredients
The second bedrock issue on which most commenting parties agree is that the NDI process as included in DSHEA is about the safety of new ingredients, not the safety of new finished products that contain one or more of those new ingredients. To require filings on thousands of new products containing NDIs whose safety has already been established would add cost and complexity while doing nothing toward better protecting consumers.
Everything old is new again
But wait—that’s not all! The comments all raise issues on the subject of Old Dietary Ingredients, how to decide whether an ingredient is old or new, and where the burden of proof lies. Several comments urge FDA to reconsider its blanket rejection of industry lists of ingredients (ODIs) that were on the market as of Oct. 15 1994. And the comments take issue with the notion that the burden lies with a manufacturer to affirmatively prove that an ingredient is an ODI by having records stretching back 17 years or more.
Natural vs. “nature-identical”
Chemical alteration is another issue of concern that relates to ODI vs. NDI status. The NDI draft guidance takes the legislative history of DSHEA at its literal word on this subject, and takes the list of “minor loss of volatile components, dehydration, lyophilization, milling, a formation of a tincture or a solution in water, a slurry, a powder or a solid in suspension” as an exclusive list of processes that do not constitute ways in which an ODI might be chemically altered and thus enter the NDI realm. AHPA’s comments specifically suggest the determination of chemical alteration should rest with the manufacturer, and similarly, UNPA calls for an evaluation of the ingredient itself rather than “applying a restrictive list of illustrative processes.”
Other issues concern the status of synthetic botanicals, which the draft guidance tosses out on their ears. Industry is in agreement that there is no scientific basis to conclude that synthetic lycopene, for example, cannot be a dietary ingredient but lycopene from a tomato is good to go. Similarly, comments take issue with the vague but troubling language in the guidance concerning the status of probiotics.
The comments differ in particulars, of course. But the broad message is clear: In the words of AHPA’s comments: “The draft guidance is hugely flawed.”