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.
Stop selling us meat!!!!
Like hothouse grow-so-fast-it’s-got-no-time-to-take-up-nutrients, toxin-sprayed, gmo is good for you. And good luck finding stuff that isn’t even if it says so. Face it: we’re not ruminants,. and we’re not built for getting our nutrients out of tough-to-break-down plant fibers. Now quit picking on poor,defenseless plants and go save the environment from some invasive pythons, or excessive whitetail (Do you know the whitetail population is 3x as large as it was before Europeans came?), or Asian carp.
Humans are omnivores – designed and created to eat meat (just take a look at your teeth!). Grass seeds (i.e. grains) were NOT designed and created to be eaten by mammals. That is what needs to be pulled off the grocery store shelves, along with soda pop.
They will never be right because they don’t it to be right. They really don’t want anyone to be healthy, just sick. Let holistic nutritionists and WestonAPrice.org run the dietary recommendations of the government. Also there is no one way to eat for everyone. The gov’t. simply doesn’t understand that there are many ways to eat, to supplement, to be healthy.
I rely on my supplements and vitamins as well as whole foods to stay healthy. The FDA must not mettle in what should be considered food, not drugs. People don’t die of vitamin overdoses. People often die or are damaged from drug overdoses. For reasons of moneyed interests from the synthetic drug companies the FDA too often sides with them and against the vitamin and food interests.
A good example of the FDA’s incestuous and unhealthy relations with the drug companies is when the FDA established a policy in the 1970s and 80s of claiming that apricot pits were cyanide and were dangerous to eat and when the FDA confiscated them from health food stores and made them illegal to sell. This claim that the pits were poisonous and could be deadly was totally and completely bogus. If there had been a smidgeon of truth to the FDA’s claims I would have died a long time ago since I often used them for snacks, found them tasty and energizing. So much for the FDA’s trustworthiness.
I’m a busted up old Veteran that’s unemployed and on SNAP. It’s ridiculous that they give me money for nutritious food, but don’t allow for any of it to go to dietary supplements. I’m a colon cancer survivor.
They saved my life by doing a partial colectomy on me, so now I have only half my colon, and have been told that I’m immune compromised because of it. Ironically, I’m told by the government that I should be getting probiotics, but I *can’t* get probiotics on SNAP, other than to get probiotic yogurts!
The probiotics in those foods are usually only the ones that assist with milk digestion…and I don’t even drink cows milk. The closest I can get is that they provide me a prebiotic fiber supplement, and I have to get that from the VA pharmacy!
Just saying all this because of the subject matter. If any of the article authors are reading this, you should add in how all this affects people using SNAP benefits to stay alive, and how that part of the government isn’t talking to the other part of the government, you know?
Thanks for listening to my grousing. 😉
It would be awesome if we could get supplements on SNAP (a Supplement program)!
Support our legislative proposal to reform a healthcare system that blocks access to natural treatments that generally cannot go through FDA approval.
HOW MANT DRUGS THE FDA HAS APPROVED KILLED PEOPLE. MAYBE UP TO 100’000 PER YEAR HOW MANY SUPPLEMENTS HAVE KILLED PEOPLE..THERE ARE A NUMBER OF SUPPLIMENT MANUFACTURES THAT PRODUCE PRODUCTS THAT ARE INFERIOR NOT PURE ETC. THE FDA SHOULD JUDICIOUSLY CONCENTRATE ON ANALIZING PILLS PRODUCED BY ALL COMPANIES FDA SHOULD NOT BE LOOKING OUT FOR THE ECONOMICK BENEFITS OF DRUG COMPANIES BUT WHAT IS IN THE BIG INTEREST OF OUR CITIZENS..SUPPLEMENTS ARE IN GENERAL OVER PRICED..BEING FACTIOUS HOW MUCH CAN YOU CHARGE FOR WEEDS.
The FDA should not be deciding what supplements anyone can have access to. They do not have the expertise to evaluate health and nutrition. They could, perhaps, determine if a supplement contains the advertised material and how much. I am better qualified to become informed and determine my nutritional needs than any federal agency. These arguments are aside from the generally understood financial interests drug companies have in eliminating their “competition” and their dominance of FDA. FDA can never be trusted to have decision making authority over nutritional supplements.