The long-awaited revision of FDA guidance rules for new supplements is finally here. It is very bad news. Highest-level Action Alert! What we are dealing with here is whether the supplement industry is allowed to innovate and create new supplements. The FDA, working as usual on behalf of the drug industry, says no. We need your help to stop this right now. It will take a huge effort on all of our parts and we need to start immediately.
More supplements face the axe at the next meeting of the FDA’s Pharmacy Compounding Advisory Committee. If recent history is any indication, the outlook is not good—unless we push back.
A PBS Frontline documentary argues that supplements are useless—relying on “expert testimony” from paid Pharma representatives. Last week, PBS’s Frontline aired an hour-long program titled “Supplements and Safety.” Jointly produced by Frontline, the New York Times, and the Canadian Broadcasting Commission, the program was clearly intended to leave viewers with the one-sided impression that dietary supplements are unregulated, unsafe—and that ultimately you, the consumer, should not have the right to stay healthy in a manner of your choosing.
The mainstream media is using a new study funded by the US Department of Health and Human Services (HHS), released last week, to renew the false charges that supplements are unregulated, unsafe, and require more federal oversight. Even a cursory examination of the data provided in the study, however, demonstrates once again that the alarmist headlines and the calls for tighter regulations are completely unsupported by the evidence.
A new study has been published by a psychiatrist working for a VA hospital educating other psychiatrists on how to protect their patients against the dangerous side effects from coconut oil and other natural supplements. However, with no recorded deaths due to the side effects of coconut oil or other natural supplements in recent years, and with the medical community themselves admitting that over 100,000 people a year die from their prescription drugs, one has to wonder who is really being "protected" with this advice?
You can’t live without this vitamin. But the FDA wants to reserve the natural form for monopoly drug companies, leaving only the synthetic form for supplements. The FDA has just released a new 109-page guidance on the revision of nutrition and supplement labels. On page 69, the agency slipped in two little paragraphs that could risk the health of millions of people who desperately need folate. It’s a sneak attack so quiet and unobtrusive that few people will even realize it’s there.
Why are the attacks on supplements becoming so loud? By now anyone not living in a cave has heard the message from the mainstream media and Big Pharma loud and clear: don’t use supplements. Either they are a harmless waste of money, or they’re a harmful threat to your health (note that these points are contradictory). This message has been repeated over and over both in journals and in conventional media outlets. It is, with very few exceptions, junk science. Even in the few instances when it is right, it is wrong. AMA-helmed medical journals twist nutritional science and the mainstream media gobbles it up. Both are financially supported by Big Pharma. It’s not surprising that “leading” medical journals and doctors continue to argue against natural alternatives to pharmaceutical drugs—they’re even more drug and drug money-dependent than even the average American.
Pro-pharmaceutical spokesmen have been repeatedly quoted as saying that dietary supplements are unregulated and need stricter oversight due to the hazards they pose to your health. This is patently false, and you only have to look at the very first sentence on the Food and Drug Administration’s (FDA) Website to settle that dispute. There, it plainly states: “FDA regulates both finished dietary supplement products and dietary ingredients. FDA regulates dietary supplements under a different set of regulations than those covering ‘conventional’ foods and drug products. Under the Dietary Supplement Health and Education Act of 1994 (DSHEA): FDA is responsible for taking action against any unsafe dietary supplement product after it reaches the market.” Dr. Paul Offit and others want supplements to be regulated like drugs, ostensibly to ensure their safety and effectiveness. But are drugs really safer? Prescription medications kill over 100,000 people each year when properly prescribed, while vitamins have not caused a single death in 27 years.
An estimated 80 percent of Americans are deficient in magnesium. The health consequences of deficiency can be quite significant, and can be aggravated by many, if not most, drug treatments. Magnesium performs a wide array of biological functions, including activating muscles and nerves and creating energy in your body by attaching adenosine triphosphate (ATP). Magnesium is very important for heart health. Excessive amounts of calcium without the counterbalance of magnesium can lead to a heart attacks, strokes, and sudden death. An ideal ratio between calcium and magnesium is thought to be 1:1. The recommended daily dose is around 700 milligrams of each. Anytime you're taking any of the following: magnesium, calcium, vitamin D3, or vitamin K2, you need to take all the others into consideration as well, as these nutrients work synergistically with one another.
In just under five minutes, Senator Durbin reveals his plan, which would effectively eliminate supplements from the shelves. Durbin says that supplement producers should be legally liable for identifying anything about the supplement that “might” interact with a drug or cause some vague and ill-defined additional difficulty. Even drug companies are not required to report how a drug might interact with all other drugs, because they could never do so. The senator also said: "I want at least to be sure, as a consumer, of what I’m consuming and what my family would be consuming." We agree, but this is already required by law for supplements and foods with one glaring exception: genetically modified organisms.