The plot thickens. Nature’s nutrient DHA, typically in fish oil, is a powerful activator of PPAR gamma, helping to break down triglycerides as well as make new metabolically-fit fat cells that boost adiponectin and help fight type 2 diabetes—the exact objectives of Big Pharma’s Avandia and Actos. DHA is a near-miracle nutrient for the heart and overall cardiovascular health and also supports strong bones. It has all of the benefits of Avandia and Actos and none of the side effects.
And this is why Big Pharma is so interested in taking over many dietary supplement ingredients. The nutrients know how to work in harmony with gene function in the human body, since nutrition was a key part of human evolution. These nutrients appear to have inherent intelligence that no drug could possibly have. They understand the context of the gene signal and thus support the beneficial gene activity. They know how to behave differently in different areas of the body to promote healthy function at every turn.
Under the FDA’s new draft guidance that redefines the 1994 Dietary Supplement Health and Education Act (DSHEA), the FDA targets many nutrients for elimination from the market, and DHA is one of them. DHA is a component of fish oil, which is a pre-DSHEA nutrient. This means that it should be grandfathered in and not subjected to the newly-published New Dietary Ingredient (NDI) guidelines.
Various companies have been able to concentrate the DHA as well as remove toxins from the oil, enabling consumers to take higher amounts of the most important ingredient in fish oil. Consumers can now easily and safely reach doses of DHA that are consistent with studies showing extreme health benefit. Such doses of DHA are known to be safe, have been tested in clinical trials sponsored by the National Institutes of Health (NIH), and are consistent with the amounts consumed by people who regularly eat fish.
The FDA’s point man on NDI guidance issues, Daniel Fabricant, has been telling the supplement industry what to expect. In a recent webinar he was asked, “Should it be necessary to submit an NDI notification over a small change in the ratios of the long chain omega-3 fatty acids EPA to DHA in one fish oil supplement versus another? Is this really a big safety issue?” Shockingly, Fabricant responded “If it is a different ingredient, a different chemical entity, then it should trigger an NDI notification.”
Fabricant is saying that any modification of basic fish oil should trigger an NDI notification. This is utter nonsense, but it is exactly what the FDA is attempting to do. What Fabricant did not bother to say to the supplement industry webinar audience was that an NDI application for modified fish oil would be denied, since GlaxoSmithKline already has a fish oil prescription drug on the market called Lovaza. Again, shocking.
Yes, the new guidance document makes it clear that if an existing drug contains any form of the nutrient DHA, a NDI will not be allowed (section IV.C.8-11). In other words, if modified DHA did not require an NDI notification, it qualified as a grandfathered nutrient, an obvious part of fish oil. But if the FDA decides that the newly manufactured form of the nutrient, in this case DHA, is different than its typical concentration in food, it can require that nutrient to have an NDI notification. By retroactively applying this definition to nutrients that compete with drug applications, that nutrient will automatically be denied NDI status. As of now, this is the intended fate of DHA. It is gravely unfortunate, as DHA is one of the most beneficial and effective nutrients offered by the dietary supplement industry.
This is a blatant power play to hand the entire high-grade DHA market to GlaxoSmithKline, one of the largest drug companies in the world. Lovaza already costs five to seven times what a similar amount of high-grade DHA costs—imagine how high their price will go up when there is no competition.
Dr Sundardas D Annamalay