This is part of Natural Products Insider’s periodic updates from trade associations and other major stakeholders. These are meant to keep industry readers updated on these organizations’ activities and priorities, as well as to issue calls for action. These are op-ed commentaries and represent the views from the authors and/or the organizations they represent, not necessarily the views of Natural Products Insider or its editorial staff.
As part of its self-proclaimed intent to modernize dietary supplement regulation, FDA has called for Congress to require mandatory product listing (MPL) of all dietary supplements in the U.S. marketplace. While some organizations have expressed support for this proposed change in the law, the American Herbal Products Association (AHPA) contends MPL could prove not only harmful, unnecessary, redundant and inaccurate—but also could restrict informed consumer access to safe dietary supplements, as guaranteed by the Dietary Supplement Health and Education Act of 1994 (DSHEA). Such concerns should be thoughtfully examined before any MPL legislation is considered by Congress.
MPL could be harmful
For at least 60 years, FDA has commonly engaged in regulatory activity, often supported by creative legal reasoning, that seems dedicated to narrowing the range of safe dietary supplement products available to American citizens. Given this historical record, we can reasonably expect FDA would overreach in implementing the scope of any MPL requirement with novel interpretations of its new authority in ways that will limit consumer access to a broad range of safe dietary supplements.
For example, starting in the early 1960s, the agency proposed various regulations to limit the amounts of vitamins and minerals allowable in dietary supplement products. These efforts culminated in August 1973 with publication in the Federal Register of a final rule that classified as a drug any product containing more than the upper limit of the then-current U.S. recommended daily allowance of such a nutrient. It bears repeating that, as a final rule, this action established, for example, that FDA would regulate a product containing more than 90 mg of vitamin C as a drug.
FDA next advanced various food additive theories that would limit access to botanical and other natural ingredients as dietary supplements. For example, in the early 1980s, the agency blocked the import of schizandra (Schisandra chinensis) and other Chinese herbs based on its rationale that a history of food use outside of the United States could not establish a food’s general recognition of safety. Perhaps most memorably, FDA determined black currant (Ribes nigrum) oil qualified as an unapproved food additive since manufacturers “added” it to empty gelatin capsules (the “food”). The U.S. appeals court that found against FDA in this case opined the agency had an “Alice in Wonderland approach” to enforcing the law.
But aren’t all these examples ancient history? Can’t we now turn the page on these painful memories? Should we expect such actions from “the new FDA” that some of the advocates for MPL describe?
Unfortunately, one can readily find more recent examples of decisions and actions by FDA that still seem intended to limit access to safe dietary supplement products or create unnecessary burdens and obstacles to their marketing. We need look no further than FDA’s draft guidance on new dietary ingredients (NDIs), issued in 2011 and again in 2016, that must be read as proposing to greatly expand the scope of ingredients and manufacturing processes that would trigger NDI notification (NDIN) requirements.
More recently, regarding restrictions that may arguably apply to isolated CBD, FDA has declined to issue a public clarification that these purported restrictions do not extend to every product made from the hemp plant that contains naturally occurring levels of CBD, despite repeated requests from AHPA and others. Of greater significance on the subject of CBD, the agency has refrained from using its clear authority to establish a lawful pathway for CBD products for over three years, despite the proliferation of such products in the U.S. market. Add to these examples the agency’s recent pronouncements on NAC (N-acetyl-L-cysteine), and we would be foolish to assume FDA will implement any eventual MPL requirement as nothing more than a ministerial obligation. Rather, our past experiences must serve as cautions to any assumption that FDA will remain content to use an MPL law just to gather labels and email addresses.
In addition, if an MPL law requires publication of a database of listed products or that registration number must appear on labels—features that MPL advocates have requested—frivolous private litigation would almost certainly increase. In fact, we should assume the plaintiffs’ bar would welcome such tools. Further, some sectors of the industry—such as contract manufacturers, small companies and new businesses—would be disproportionately affected by the expense and burdens of compliance with an MPL requirement. All of these effects would likely cause market contraction and layoffs during this period of economic uncertainty, and consumers would bear the ultimate brunt of these impacts in the form of higher prices and fewer choices.
MPL is unnecessary
FDA’s Office of Dietary Supplement Programs has for several years identified public safety, product integrity and informed decision-making by dietary supplement users as its three regulatory priorities. AHPA shares these priorities, but only through some strained reasoning can one argue that an MPL requirement would advance any of these regulatory priorities for dietary supplements.
Regarding public safety, recall records and adverse events data suggest dietary supplements may well be the safest class of goods regulated by FDA. Supplements are certainly safer than romaine lettuce, spinach and shellfish, but there is no demand for MPL for these foods or for conventional foods generally. Further, FDA already has adequate tools for identifying, investigating and addressing safety issues that may arise in the dietary supplement market.
When it comes to product integrity and the product quality demanded by FDA’s cGMP (current good manufacturing practice) regulations, AHPA and others—especially cGMP-compliant manufacturers—have long encouraged FDA to assertively apply its existing authority, tools and resources to enforce compliance with these rules. But a simple listing process will contribute nothing whatsoever to product quality or integrity.
Any pretense that an MPL requirement would in any way improve informed decision-making by consumers seems ironic, at best. Indeed, we can expect some degree of consumer misunderstanding of the limited significance of a product’s appearance in a public database or a registration number on a label. Note also that current law forbids marketers of dietary supplements from directly providing scientific information about their products, even when truthful and not misleading, if the information suggests or confirms therapeutic efficacy. If it is time to “modernize” dietary supplement laws and regulations, we would do better to consider amending the law to remove the current statutory barriers that today prevent fully informed decision-making.
MPL would be redundant
FDA already has sufficient regulatory authority to identify dietary supplements in the market. This starts with the requirement for all facilities engaged in the manufacturing, processing, packing or holding of dietary supplements for consumption in the U.S. to be registered with FDA. All such facilities are subject to FDA inspection at any time, and, during inspections, FDA may obtain all product labels and interstate shipment records. The agency may also review the mandatory “one-up/one-back” records that dietary supplement firms must retain to ensure ingredient and product traceability.
FDA has used these inspection authorities for many years. In other words, we can assume FDA has already collected a large number of dietary supplement labels, and it knows how to obtain more of these. In addition, over 85,000 “on market” dietary supplement labels appear today in the Dietary Supplement Label Database (DSLD) maintained by the National Institutes of Health’s Office of Dietary Supplements. American taxpayers already support this system to the tune of an estimated $1 million or more each year, and AHPA has recommended that, should Congress nevertheless decide to establish an MPL requirement, a voluntary or otherwise existing listing in the DSLD should fully satisfy the new requirement.
In the rare instances in which FDA identifies a public safety threat associated with a dietary supplement, the agency has various other authorities available. These include mandatory recall orders, administrative detentions, food facility registration suspensions, import refusals, consumer advisories, and injunction, seizure or criminal enforcement proceedings.
Ultimately, a listing of products on the U.S. market will not magically cure the ills of insufficient FDA enforcement or resources. Administering an MPL requirement for dietary supplements instead could further strain FDA’s resources, unless the agency envisions that industry-paid user fees would fund the program. AHPA members strongly oppose any form of industry funding for an MPL system, which would likely necessitate increases in the cost of these health-promoting products for consumers.
MPL poses data collection questions
Proponents of an MPL requirement apparently envision a nearly effortless process with no approval or clearance required by FDA to satisfy the listing obligation. How then will the agency verify label accuracy or “dietary supplement” status in submissions? Compliant companies would submit accurate information, but noncompliant companies (including marketers of drug-spiked products, which are illegal drugs that masquerade as dietary supplements) would either ignore the MPL requirement or submit false information to avoid scrutiny. We should thus assume that the data submitted under an MPL requirement would be incomplete and inaccurate.
Any attempt to correct this flaw by including an FDA premarket approval or clearance step to address this inaccuracy concern, however, would open up this purportedly straightforward listing requirement to FDA interpretation on a label-by-label basis. We can readily imagine FDA would refuse to accept submission of a label for a product that includes ingredients like hemp, CBD or NAC, given its most recent positions on these ingredients.
It also warrants asking how FDA would evaluate the NDI status of a product like a simple herbal tincture if submitted by a company that entered the industry after 1994. If the agency applied the very expansive interpretations it presented in its 2011 and 2016 draft guidance on NDIs, we should not dismiss a concern that FDA will seek to use the MPL process to demand documentation that any such tincture does not require an NDIN.
In any event, any corrective measure that allows FDA approval of listed products or submitted labels will almost certainly disrupt the balance created by DSHEA that keeps safe and well-regulated dietary supplements accessible to the American public.
Conclusions
There are times that any regulated industry should accept, and even advocate for, additional regulation. For example, the dietary supplement industry actively supported passage of the Dietary Supplement and Nonprescription Drug Consumer Protection Act in 2006 because this amendment to the Federal Food, Drug and Cosmetic Act provided a direct benefit to public health.
On the other hand, any substantive change to current laws should fill an actual and non-redundant need, where existing tools and programs cannot address the perceived gap that the proposed new law would fill. Any such change should also fill the identified gap in the least burdensome manner possible.
When it comes to amending the law that has protected the freedom of Americans to use dietary supplements for over a quarter of a century, we must safeguard against any tendency toward regulatory reinterpretation or overreach. This is essential to maintain the balance that provides FDA with all the regulatory authority it actually needs, while also ensuring informed consumer access to a broad range of safe dietary supplements, as promised by the U.S. Congress in 1994. Ultimately, an MPL requirement for dietary supplements does not pass these threshold tests.
Michael McGuffin has served as president of the American Herbal Products Association since 1999, leading the association in its mission to promote the responsible and sustainable commerce of herbal products to ensure that consumers have informed access to a wide variety of safe herbal goods. McGuffin also serves on the boards of directors of the American Herbal Pharmacopoeia and United Plant Savers, and on the advisory boards of the USC School of Pharmacy regulatory science master’s degree program and the Appalachian Beginning Forest Farmers Coalition. An industry veteran, McGuffin has been active in the herbal community since 1974, and has taken the lead on legislative matters and regulatory advocacy that have shaped the herbal and natural products industry over the last several decades.
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