Election brings 'DSHEA critics agenda' to the fore

Mandatory product registration. This may stand the best chance of passage because a number of supplement trade groups have embraced the concept. This is led by the Council for Responsible Nutrition, which began the Supplement OWL—Online Wellness Library—as a self-regulatory initiative to list all products on the market (or at least those willing to participate). The OWL provides a product image, supplements facts information, and other info on ingredients, dosage form, serving size, categories of use, product claims, contacts and other information. It could be a model for the FDA’s desire to have a product registry.

Close the GRAS self-affirmation “loophole.” Besides ignoring it altogether, the easiest way to get around filing New Dietary Ingredient (NDI) dossiers is to instead to the GRAS route. There are two ways of doing this. One is to file a GRAS dossier with the FDA and await a “no objection” letter from the agency. The other way is to conduct a “self-affirmation” GRAS filing. It’s about the same thing, only a company’s toxicology team it assembles declares an ingredient safe and not the FDA. Some see this as the loophole under the thinking that a self-affirmed GRAS team might not be quite as diligent as the FDA.

State AGs empowered. Congress authorizes state attorneys general to enforce federal dietary supplement laws. State-level AGs have flexed their muscles in lieu of the federal agency. The infamous New York attorney general sting operation of 2015 was just such an instance. The notable conclusion to that action was the widely criticized manner in which the NYAG went about its operation, using DNA testing but no follow-up chemical analysis such as HPLC to validate the clear limitations of DNA tests. Would the FDA have been so slipshod?

Targeting high-risk categories. The big three here are sexual performance, weight loss and muscle-building supplements. These have a troublesome history, thanks to questionable ingredients including pharmaceuticals. The goal here is a pre-market product testing and audits of products in this category.

Labeling supplements that interact with pharmaceutical drugs. There is some contention over this because it is emblematic of the battle between drugs and supplements. That is to say, why is the onus on supplements to pronounce which pharmaceuticals it interacts with, instead of drugs having warnings about how its efficacy can be altered in the presence of food ingredients?

Mandatory reporting of non-serious AERs. Adverse events reporting began in 2009 when the FDA issued a guidance under the Dietary Supplement and Nonprescription Drug Consumer Protection Act. These are to be submitted to the FDA within 15 days of receipt. This is usually when a person is hospitalized. Including non-hospitalized, “non-serious” events raises the bar on supplements and would no doubt give the illusion of supplements being a non-safe category of consumer products.

Deadline to complete NDIs. In 2011 and again in 2016, the FDA deigned to issue a rule on NDIs. Both were roundly criticized by the supplements industry, the second one even by a strongly worded letter from DSHEA co-author Utah Senator Orrin Hatch. While the FDA never exactly pulled the rules, it didn’t exactly say they would stand either. The current thinking in the industry is the FDA has continued as if its second document is the way the agency sees things, Hatch’s letter notwithstanding. However, the FDA has hardly been an enforcement agency around this issue. What could happen now? Will the FDA try a third time? This is “a likely development,” according to Evich. “In a Biden FDA we may see a re-issuance of that.”