Senator Durbin’s bill, which will be introduced in Congress this week, is likely to be another example of burdensome and unnecessary legislation.
The staff of Sen. Dick Durbin (D-IL) has confirmed to ANH-USA that he plans to introduce new legislation this week—the Dietary Supplement Labeling Act—purportedly in response to the recent melatonin-filled “Lazy Cakes” brownie controversy we reported on recently.
The final bill is not yet available, but friends on Capitol Hill say the bill’s language is expected to include the following:
- Enhanced FDA registration requirements: Companies will have to list the names of their products, the ingredients in those products, and provide a label to FDA as part of their registration submission.
- Enhanced labeling requirements: FDA will require warning labels for certain products where the government decides there is risk of an adverse event (this to be determined through a risk review process with the Institute of Medicine), drug interactions (as with St. John’s Wort and antidepressants), or may be contraindicated for subpopulations like pregnant women. In addition, the precise weight or amount of the different dietary ingredients will have to be disclosed for products that are sold as proprietary blends, and product labels will have to include a batch number to help facilitate any possible recall.
- Supplements vs. conventional foods with food additives: FDA will need to publish guidance about the definition of “conventional food” so that legitimate dietary supplements can be differentiated from products like Lazy Cakes. This is intended to prevent a food producer from falsely labeling it a supplement.
As noted above, the final bill could differ from this. But this is what is expected to be in it.
It is worth noting that the stated impetus for the bill, the Lazy Cakes issue, is an example of where the FDA has simply failed to enforce current law. Melatonin in Lazy Cakes are unapproved food additives posing as a dietary supplement to evade the law. Before a substance may be added to a food, a Food Additive Petition must be submitted to the FDA and must include data demonstrating safety, unless the ingredient and the amount is Generally Recognized As Safe (GRAS)—which clearly isn’t the case for melatonin cakes! Just because FDA dropped the ball on Lazy Cakes doesn’t mean we need further potential regulations (which FDA may then either disregard or misuse).
Sen. Durbin also seems concerned with energy drinks that might be mistaken for dietary supplements. In this case, the FDA has been sitting on a draft guidance that clearly outlines the difference between beverages and dietary supplements since 2009. The FDA just needs to stop dithering and complete its work.
As for the enhanced registration requirements, current law already requires that all facilities must register with the FDA under the Bioterrorism Act. Under DSHEA, labeling must already bear a Supplement Facts table that includes the name and quantity of each dietary ingredient; in the case of proprietary blends, it must include the name of each ingredient and the quantity of the whole blend. To require the weight or amount of each ingredient in proprietary blends wouldn’t tell a consumer anything more although it could tell a competitor or a drug company something more. And disclosure of allergens is already required under the Food Allergen Labeling Act.
The FDA is already biased against dietary supplements. We strongly suspect this is because supplements do not go through drug approval processes costing close to $1 billion on average and therefore do not support the FDA’s own budget. We fear that further registration requirements and adverse events warnings could be a slippery slope to the European model—which has drastically reduced the number of supplements that may be sold, and is in the process of reducing potencies to ridiculously low levels. It wouldn’t surprise us if labels require so much warning information, determined by officials hostile to supplements, that it wouldn’t fit on a reasonably sized bottle.
Enhanced labeling requirements could be useful, depending on how this requirement is defined. We all want to know about the benefits and the risks of dietary supplements, and we need to know where potential drug interactions and real adverse events are a possibility. However, the number of adverse events from supplements is so small compared to those from conventional medicines, and the risks from most dietary supplements so insignificant, that we fear FDA will take this to an extreme, which could dissuade consumers from using supplements based on insignificant or false threats.
The best fix for this problem is to move supplements out of the drug agency and into their own agency under Health and Human Services. It doesn’t work for the supplement regulator (currently FDA) to be so beholden to drug companies, since drug companies are very afraid of supplement competition, despite the current government gag orders forbidding supplement makers from explaining their medical prevention and treatment uses.
We’ll be sure to keep you updated about this bill. Sen. Durbin is widely considered to be the senator most unfriendly to supplements, which puts us on our guard, but we will hope for the best.