FDA promises industry-friendly “modernization” of dietary supplement regulation

 

From the USFDA article “6 Tip-offs to Rip-offs: Don’t Fall for Health Fraud Scams”

On Monday, FDA Commissioner Scott Gottlieb, MD, announced

a new plan for policy advancements with the goal of implementing one of the most significant modernizations of dietary supplement regulation and oversight in more than 25 years.

Depending on who you ask, this is either mostly unnecessary (the dietary supplement industry); a welcome development, albeit with insufficient resources (some consumer advocates); a meaningless PR move (another consumer advocate); or wholly insufficient (me).

Dr. Gottlieb begins with some interesting statistics: three out of four Americans regularly take a dietary supplement. For older Americans, that rate rises four in five; for children, it’s one in three. Since Congress passed the Dietary Supplement Health and Education Act (DSHEA) in 1994, the dietary supplement market has grown ten-fold, from a $4 billion to a $40 billion industry, and from 4,000 unique products to “more than 50,000 – and possibly as many as 80,000 or even more,” a tacit admission that the FDA doesn’t even know what dietary supplements are on the market because DSHEA has no requirement that the industry let the FDA know what products it’s selling to consumers.

According to Dr. Gottlieb, the FDA will focus on collaring the “bad actors”, those who market potentially dangerous products and make unproven or misleading claims about their products’ health benefits. While this is laudable, by narrowly defining the terms “potentially dangerous” and “unproven or misleading claims” in a manner suitable to the dietary supplement industry, the FDA fails to address the legally authorized health dangers and misleading claims baked into the dietary supplement regulatory scheme by DSHEA.

To Dr. Gottlieb, “potentially dangerous” means one of three things: (1) the supplement contains unlawful ingredients, including drugs like sildenafil or tadalafil; (2) the supplement is not manufactured in compliance with current good manufacturing practice regulations; or (3) the supplement has obviously inherently dangerous ingredients, like kratom or highly concentrated caffeine.

“Potentially dangerous” apparently does not include, however, products sold to consumers as beneficial to health but which are, in fact, not tested for safety or efficacy prior to their going on the market, a deficiency that necessarily eliminates any real risk/benefit calculation. That is because DSHEA does not require such testing. (The law does require submission of some safety, but not efficacy, information on new dietary ingredients, a topic we’ll return to in a moment.) Although manufacturers are supposed to have substantiation backing claims that their products benefit a structure (like the skeleton) or function (like digestion) of the body, the FDA is not permitted to see their evidence. (When a few dietary supplement manufacturers did agree to share their evidence with the government, a GAO report found it less than adequate.)

Dr. Gottlieb carefully elides the issue of efficacy in his statement. He says he has “personally benefitted from the use of dietary supplements” and recognizes the benefits of “certain” supplements in a comprehensive health plan. He says that it is “clear” to him that supplements “play an important role” as we “strive to stay healthy.” What he doesn’t do is quantify that role or identify which of the “certain” supplements actually have benefits. In fact, according to the best available evidence, with the possible exception of specific groups like pregnant women or those with verified nutritional deficiencies, the role of dietary supplements in health is miniscule to none and any health benefit remains unproven for the vast majority of supplements on the market

“Unproven or misleading claims”, are apparently limited, in Dr. Gottlieb’s view, to claims that a dietary supplement can prevent, treat, or cure disease. As he rightly points out, only drugs can legally claim they treat disease and must gain FDA approval before they are sold in order to help ensure they are safe and effective for their intended medical use. To bring home that message, the same day as Dr. Gottlieb’s statement appeared, the FDA sent warning and advisory letters to 17 companies whose products, including dietary supplements, are being illegally marketed to prevent, treat, or cure Alzheimer’s disease and other serious diseases, like diabetes and cancer.

What he does not mention, however, is that consumers cannot necessarily distinguish between the impermissible “prevent, treat, or cure” and the permissible, under DSHEA, structure/ function claims. Indeed, even the FDA itself has trouble telling the difference. To an older individual worried whether memory loss is the first sign of dementia, a dietary supplement’s claim that it “enhances memory” or “improves cognition” could well be read as “prevents dementia”. As a recent “Viewpoint” article in JAMA Network lamented, even though no known dietary supplement prevents cognitive decline or dementia, the promotion of supplements to improve cognition and brain health is itself a $3.2 billion industry that benefits from high-penetration consumer advertising.

Thus, in the schema of Dr. Gottlieb, the FDA’s job is to ratchet up its pursuit of the “bad actors” who “exploit the halo created by quality work of legitimate manufacturers” and other players in the industry “most of whom act responsibly”. In his view, all consumers need to “make healthy choices” is available, for the most part, within the current framework of DSHEA via access to “safe [meaning, basically, unadulterated], well-manufactured, and appropriately labeled products,” even if the information on those labels isn’t backed by solid scientific evidence and safety warnings (except for supplements containing iron) are not required. (Labels must, however, include the ineffective Quack Miranda Warning.)

Lest the supplement industry be alarmed by this newly energized FDA, Dr. Gottlieb’s statement contains assurances that the FDA will be “flexible enough” in evaluating product safety so as not to discourage “innovation,” a word he uses five times (plus one “innovate”) in a statement less than four pages long, mostly in the context of “promoting” this innovation and protecting innovation from “barriers.” He does not explain what innovation he is expecting. As it currently stands, “innovation” in the dietary supplement industry seems to me to consist of figuring out how to combine the same ingredients in different ways and sell the results as a new product.

Other than stepped-up enforcement actions against the bad actors, details about how the FDA is going to accomplish this modernizing and reforming are sketchy. Plans include the “Botanical Safety Consortium”, a “public-private partnership” to evaluate the safety of botanical ingredients and mixtures in dietary supplements to “promote the goals of safety and effectiveness”. That’s good news. According to the American Botanical Council, an industry group, herbal supplement sales increased 8.5% in 2017, topping $8 billion, the strongest sales growth in 15 years “and there appears to be no slowing in sight”.

Dr. Gottlieb also promises “communicating to the public as soon as possible when there is a concern about dietary supplement.” While admirable, this may not be effective. A small study, recently published, found that supplements still contained prohibited ingredients even after public notices targeting those ingredients had been issued, providing further evidence, according to the authors, that a post-market regulatory system is insufficient to ensure the safety of supplements.

In what The Washington Post described as “a nod to industry,” Dr. Gottlieb also says the FDA will review its regulations on new dietary ingredients “to make sure they are flexible enough to ensure product improvement”. If a supplement incorporates an ingredient not in use when DSHEA was passed in 1994, what the law calls a “new dietary ingredient” (NDI), its manufacturer must notify the FDA and include the NDI’s history of use or other evidence of safety. (I’m not equating “history of use” with “evidence of safety”, but the law does.) The industry has been miffed by the FDA’s interpretation of this requirement ever since the agency issued new draft guidance on NDIs in 2016. Apparently, Dr. Gottlieb took their complaints to heart.

Interestingly, Dr. Gottlieb hints that amendments to DSHEA might be part of the solution, although not one he or the FDA will commit to, at least for now. At this time, all he will admit to is that “there may be value in a broader public conversation about whether changes to the law might be helpful” while at the same time “preserving the law’s essential balance,” this balance apparently consisting of “preserving consumer access to lawful supplements,” (i.e., the current system of pro-industry regulation mandated by DSHEA) and fulfilling the FDA’s duty to protect the public from unsafe supplements. In fact, he maintains that none of this must impose “any significant new burdens on responsible firms”, which is, as you will recall, the majority of the supplement industry in his view.

One of the DSHEA amendments could be, he suggests, a list of products on the market and their ingredients. Right now, all manufacturers have to do is register their facilities with the FDA, although we don’t know how many are complying because we don’t know how many are out there or where they are. And we have no idea what they’re selling.

The industry is not universally warm to the idea of a mandatory registry. They are all for the “bad actor” initiative, which eliminates the most egregious offenders and the bad publicity for dietary supplements accompanying publication of their scandalous behavior. But, quarrels with NDI guidance aside, they very much like the current scheme, which guarantees, in their view, that “Americans have continued access to safe, natural, and affordable supplements.” Or at least they want some quid pro quo for cooperating with any tinkering with DSHEAAccording to the American Herbal Products Association, this would include measures to

appropriately reduce burdens on the industry or create new opportunities for it and the consumers it serves, for example in the context of nutrient content claims.

Consumer advocates are generally positive, but at least one wonders where the authority, and resources, will come from to implement all of this. According to Peter Lurie, MD, MPH, former FDA official and president of The Center for Science in the Public Interest:

The FDA is hampered by a terrible law and drastically limited resources. Within that there’s only so much you can do.

He’s right on both counts. DSHEA is a terrible law, or, as we like to say here at SBM, it’s a travesty of a mockery of a sham. In 2017, an FDA official told a reporter that the agency patrolled the multi-billion dollar supplement industry and its tens of thousands of products with 26 people and a $5 million budget.

Pieter Cohen, MD, JD, who frequently exposes the dangers of dietary supplements in the medical literature, thinks Dr. Gottlieb is overselling the idea that the FDA is moving forward, characterizing this instead as “restating things they have been doing for years” and “a big PR push.”

In my view, while increased enforcement of DSHEA’s weak consumer protections is not a bad thing, this is lipstick on a pig. DSHEA needs to be tossed out and replaced with a new law, one that protects consumers and not the dietary supplement industry. That’s what Dr. Gottlieb should be saying, but won’t. Prior to his confirmation, he assured former Sen. Orrin Hatch, the industry’s protector-in-chief,

“As someone who uses dietary supplements every day, I believe they serve an important role in health promotion for millions of Americans, and I support consumer access to these products.” He also wrote that FDA’s current regulatory framework under DSHEA provides adequate enforcement tools to remove unsafe dietary supplements from the market and “if confirmed, I would commit to enforcing DSHEA, as intended by Congress.”