The Strength of FDA Approved Statements

"*This statement has not been evaluated by the FDA." Seen that phrase much? Well, my response is who gives a rat's ass? What I mean is, well, many of us already know and acknowledge that the FDA does not evaluate the efficacy of most supplements. As with foods and medications, despite differing FDA laws, in the past they would generally wait until an item kills someone and then they jump in and pull it. But, what I mean precisely when I imply, not especially subtly, that I do not completely value the FDA's opinion, nor do I require the agency's approval, is that in fact many substances, actual food and herbs, have been around for generations, are unprocessed and have been proven by "ancient wisdom." By ancient wisdom, I don't just mean on-line articles, I mean solid research, especially in Traditional Chinese Medicine (TCM). (Don't even get me started on how the younger generation thinks anything that google dredges up is research.)

While the FDA under new leadership is getting a handle on how to proceed with non-food chemicals already so pervasive in our food supply, perfectly legally, the new FDA has only tweaked its stance on supplements. For example, the FDA recently implemented the requirement that companies have a domestic telephone number on the bottle of dietary supplements; the agency also recently changed views suggesting it will begin viewing drinks that contain supplements ("nutrition drinks; functional drinks") as foods rather than dietary supplements which would subject those drinks to food standards such as GRAS (generally recognized as safe) instead of its even more lax regulations applicable to dietary supplements. For example, drinks that contain botanicals (even ones that have been consumed or used by traditional societies for years) might be determined to fail under GRAS because there has not been a significant U.S. market ruled by large manufacturers willing to say these items are generally recognized as safe. In reality, this type of regulation could grossly favor a company like Coca-Cola while it would drive under small companies like the makers of kombucha who would have trouble proving some of their relatively new (to the large scale US market) herbal ingredients are safe. So, although many people are pushing for more regulation, I am not sure whether maybe we should push for less. Just as another example, oddly, I was in GNC. Oddly, because I never really set foot in there, but anyway, I was holding in my hand a dangerous weight loss supplement, one that prevents the absorption not only of bad fats but most likely of healthy necessary fatty acids. And, the store employee came up to me and said, "That one is the best. See, it is approved by the FDA." Is he telling all of his customers this? So, of course, I said, "Did they do long term studies on its effects on the workings of the brain and on the Alzheimer's and did they look into its effects on heart disease rates?" And he replied, feebly, "I think all they did was test to see if people actually lost weight with it." Hmm. So, I looked it up and some people did lose weight. Yet, a lot of people did not lose weight. It was moderately effective when used as part of a plan with exercise, etc. So, I am just saying if I were to use a natural fiber drink, or an herbal blend to lose weight, or a kombucha to boost immunity, or a drink that includes green tea extract or dandelion, or bee pollen for allergies, would I really value the FDA's mark of approval as this sales person seemed to? And, as for the really dangerous substances, like added caffeine or vitamins which taken in excess can cause severe problems, shouldn't people know by the very ingredients that there is a danger? It will be interesting to see whether GRAS will apply to added vitamins but should botanicals and plant extracts take the fall with the bad stuff? And, if these companies continue production would they be able to prove the ingredients are GRAS if they are asked?

So, I ask are we more scared of bilberry spritzers or those things the FDA does approve:

FDA approved: aspartame (more headache complaints than any other approved food) TBHQ, BHT, BHA Yellow # 5 (tartrazine), Red #40, Blue Lake

Bovine growth hormone

Maybe, just maybe, another approach would be to create a distinction between naturals and chemicals. Corporations could be required to prove all chemical foods are completely safe before they go to market and the FDA could leave the organic botanicals and the all natural organic plain foods that grow from the ground out of it. Hmm...