The newest Dietary Guidelines for Americans continue to get it wrong—and show how the government is undermining its own recommendations. Action Alert!
The newest iteration of the government’s Dietary Guidelines repeat a number of the mistakes of previous guidelines, particularly regarding saturated fat and added sugars. The guidelines do note the importance of dietary supplements (though the government’s idea of adequate leaves much to be desired). However, what isn’t mentioned is that, while the guidelines recommend supplements for certain age groups and populations, the FDA is working on its “new supplement” guidance that threatens thousands of products on the market. Fixing this guidance is a crucial component of our legislative goals.
The guidelines note that vitamin D supplementation may be necessary, though government recommendations are 600 IU for most people and 800 IU per day for those over 75—nowhere near enough to achieve optimal levels of vitamin D recommended by integrative experts. Elsewhere there are recommendations for infants to take vitamin D and in some cases for pregnant mothers and young children to supplement with B12.
The guidelines barely scratch the surface of the importance of dietary supplements. Americans are deficient in many micronutrients. Research shows that micronutrient inadequacies may impact long-term health, increasing risk for chronic diseases like cancer, cardiovascular disease and type 2 diabetes.
Despite the dietary guidelines noting (however insufficiently) the importance of dietary supplements, the FDA is working to undermine our access to these crucial health products. This stems from the new dietary ingredient guidance.
According to the 1994 Dietary Supplement Health and Education Act, any dietary supplement introduced to the market after 1994 is considered “new” (an NDI) and the manufacturer must notify the FDA in advance of plans to market the product. The problem is that the FDA is using this to create a drug-like pre-approval system for supplements that experts have estimated will result in the elimination of tens of thousands of supplements.
Part of the issue is that the FDA is adopting a broad definition of an NDI and thus expanding the number of supplements that will be subject to these procedures. For example, supplements that have not been “chemically altered” are not required to comply with these procedures; but the FDA is adopting an expansive definition of what it means to be “chemically altered” such that almost all modern supplements would probably qualify and thus be subject to NDI requirements.
There are further problems. If a drug company files an investigational new drug (IND) application on a dietary ingredient before an NDI notification has been filed on that ingredient, the drug company can petition the FDA to ban the supplement—even if no drug ever comes to market. This has already happened and could happen to many more supplements.
As we’ve been telling you over the last few weeks, we’re working on a landmark legislative proposal that fixes this and many other problems in our healthcare system. It addresses the issues mentioned above by:
- Clarifying definitions in the NDI guidance to appropriately reduce the number of ingredients that qualify as “new supplements.”
- Creating an expiration date on INDs.
- Eliminating the market exclusivity for INDs when filed on supplements already on the market.
Action Alert! Support our legislative proposal to reform a healthcare system that blocks access to natural treatments that generally cannot go through FDA approval. Please send your message immediately.