The time for considering a “DSHEA 2.0” is long over, according to supplements lawyer and outspoken firebrand Todd Harrison. Instead of negotiating incremental change, Harrison is working with the Organic and Natural Health Association to propose what he is calling “DSHEA 10.0.” It reads like a complete overhaul in the language, he shared with WholeFoods Magazine.
Harrison outlined a framework for this new supplements regulation at Natural Products Expo West on March 5, highlighting what he described as much-needed reform around claims language, drug preclusion, and federal supremacy clause reform to forestall state-by-state regulation over supplements.
In short, Harrison called it time to stop tinkering with a law written before modern developments like the internet and synthetic botanicals had fully manifested. It was time instead, he said, to start over from scratch.
“It’s time for a reset,” Harrison said. “It’s time to, for lack of better terminology, update the operating system. It’s not that DSHEA was a bad thing. It was a good thing, but it is time to look at the whole structure from the get-go.”
Starting from scratch: DSHEA 10.0
One of Harrison’s principal arguments for the start-from-scratch report focuses on claims. The lawyer decried a system that forces brands to dance around clear evidence and intention, leaving consumers confused. “Does it make sense to any of you that I can say it helps alleviate occasional heartburn, but I can’t say it helps alleviate heartburn?” he asked.
In Harrison’s proposed bill, regulators would formalize scientific requirements for claims, which would stop short of drug claims but make it clear what the product was intended to do. “It is time that we get rid of these stupid word salad claims,” Harrison said.
The Old Dietary Ingredient (ODI) list is also in the proposed bill’s sights. As specified in DSHEA, ingredients that were on the market and sold as dietary supplements before the law was passed in 1994 are considered “original” and do not require New Dietary Ingredient (NDI) applications. From Harrison’s vantage, the date makes the law’s intentions unworkable. According to him, surveying the market pre-1994 is all but impossible. He argued that a more recent date would be a more feasible dividing line between an ODI and NDI. “We need to reset the grandfathered date. I don’t really care whether it’s 2010, 2015—I don’t know if I’d go as far as 2025,” he noted.
Drug preclusion could also be made clearer and the guardrails more well-defined, Harrison said. That can’t come from piecemeal guidance like what was provided in the FDA’s September ruling on NMN, Harrison contended. “We need to start looking at how we resolve these ambiguities in the preclusion issues. Guidance instead of law never works very well.”
Harrison took the matter further by noting that some ingredients sold in drugs at higher dosages could be used in supplements at lower dosages. He pointed to Lovaza, the prescription-strength fish oil drug originally developed by GlaxoSmithKline, as an example of how dietary ingredients and prescription drugs could coexist with similar ingredients.
Many of the proposals would undoubtedly be welcomed by those in the industry, but Harrison accepted that the bill’s inclusion of a mandatory product list was not one of them. Resistance has been loud from parties that include the Natural Product Association (NPA).
Harrison was not a fan of the concept when he first heard about it, but he eventually saw it as providing a mechanism for the FDA to take irresponsible brands out of the game and for consumers to see that a brand was not attempting to fly under the radar. “If the platforms and retail stores know your product is at least registered and listed with the FDA, they at least have some idea whether you’re at least following some of the laws,” Harrison said.
The new bill’s version of the mandatory product goes further than the concept supported by the Council for Responsible Nutrition (CRN) and spelled out in bill proposed by Illinois Sen. Dick Durbin, Harrison explained. “Your failure to list your product means your products are adulterated, as a matter of law,” Harrison said. “I don’t think it’s useful if you don’t add teeth to it.”
Even without the concepts that might be troubling to industry figures and other trade associations, the mix of surely welcomed provisions was unlikely to inspire eagerness to what is commonly termed “opening up DSHEA,” Harrison admitted. “People are saying, ‘Oh, we can’t touch DSHEA because it’s the Holy Grail.’ Or, ‘Gosh, you don’t know what’s going to happen if you touch it,’” he said. Such people, he argued, were ignoring the responsibility to meet new challenges with a new law. “There’s a reason to fix things before they get broken.”
Reframing the discussion
Industry and trade association reluctance has not kept Organic & Natural Health Executive Director Karen Howard from giving Harrison’s proposed bill a platform. Recent years of hand-wringing about the law losing relevance in the modern market and tentative attempts at incremental changes have proven that it is time for a “whole-new-ballgame” approach, Howard said.
“We’re not going to fix one problem. We’re going to get more down to the intention of the law itself. I like that approach. It’s not going to go over well with everyone, but it makes for a really great opportunity to bring people together,” Howard said, describing a broad discussion among brand holders, suppliers, and manufacturers that might not happen under the guidance of a particular trade association.
According to Howard, the bill may stand more of a chance than many would expect in a Congress that has proven catastrophically fractious. She was adamant that U.S. senators and representatives are hungry for bipartisan bills they can point to as solving a problem. “The perfect example of that would be the homeopathic bill that they’re working on, which is making great strides,” Howard said.
Harrison’s discussion garnered a small audience at Expo, but industry veteran and product formulator Doug Lynch said that if nothing else, the proposed bill reframed the discussion in a fresh way. Lynch was particularly drawn to Harrison’s ideas around claims and the ODI list. “If we don’t have these discussions, we’re just meeting the definition of insanity, which is doing the same thing over and over again and expecting different results,” Lynch said.
For Harrison, that discussion was welcome, but discussion alone wouldn’t be enough. In his eyes, DSHEA is out of date. The relationship between industry, consumers, and regulators is very different than when the law was written. The threats are different, too. “DSHEA had its time. It wasn’t a bad legislation back in 1994, but we don’t live in 1994 anymore,” Harrison said.
Related: The United States of HealthCall for Comments: FDA Public Meeting Will Explore Scope of Dietary Supplement Ingredients
