Today, both the FDA and Sen. Dick Durbin (D-IL) dropped policy “bombs” on those of us who use dietary supplements. It is no mere coincidence that both were released on the Friday before a holiday weekend. By timing the introduction of their anti-supplement legislation and regulatory guidance this way, the FDA and Sen. Durbin are both hoping to evade negative publicity. We think it is better to keep American citizens fully informed, and with your help, we will get the word out. Please send this communication far and wide.
First, the FDA has issued draft guidance for complying with the New Dietary Ingredient (NDI) notification protocols contained in the Dietary Supplement Health and Education Act (DSHEA). As you may recall, DSHEA said that supplements already on sale prior to the passage of the act were “grandfathered” in, and did not have to be reviewed by the FDA. New supplements developed after the Act have been in a kind of limbo waiting for the FDA to spell out the procedures to be followed.
These new supplements have always been at risk because of the uncertainly surrounding their regulatory status. And many of these new supplements are extremely important for our health. We won’t name them, because to do would be to put a bull’s-eye on them for the FDA to shoot at, but you would recognize many of them and may be currently taking them.
DSHEA was passed in 1994. The FDA has thus taken seventeen years to provide regulatory guidance for these new supplements. Now a draft version of guidance is here, and it isn’t good. It is just another effort by the FDA to suffocate the supplement industry so that everything—supplements and drugs alike—will go through the vastly expensive drug approval process, a process that pays for FDA salaries.
We have said it before and we will say it again. Supplements cannot usually be patented. No non-patentable substance can be taken through a drug approval process that on average costs a billion dollars. If supplements are treated like drugs, there simply won’t be any supplements. The FDA knows this perfectly well.
The new draft guidance is written in the usual regulatory non-English, but buried within it are definitions of “new supplements” that will make more and more supplements subject to the new rules. The rules themselves are designed to make it harder and harder to market new supplements, all of which will need to submit notification to an agency that is fundamentally hostile to the supplement industry. Not only does each supplement require its own notification, a separate notification must be submitted by each company that offers it. Additionally, notification must be submitted again if the supplement is reformulated in any way or offered in combination with any other supplement or ingredient. Based on what the FDA has done in the past, many more applications will be rejected than accepted and the cost of the whole process will be high.
The FDA is required to give us 90 days to comment on their proposed guidance. Our experts are busy analyzing the proposal in all its detail and we will report on it again and provide an Action Alert in our next newsletter right after the holiday. We already know this needs to be stopped. With your help we will do everything we can to change it. Your ability to use supplements not already documented as having been on the market under the same exact name and formulation prior to 1994 will depend on it.
As we mentioned above, Sen. Durbin’s much-feared Dietary Supplement Labeling Act of 2011 (S.1310) has been formally introduced in Congress. The language is not available online yet, but the draft procured by ANH-USA yesterday reaffirmed the analysis we sent you earlier this week. Look for our in-depth article and Action Alert on S.1310 in our newsletter on Tuesday, July 5th!
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Hands off supplements!!!!!!!!!!!!!!!!!!
Supplements have kept me healthy where pharmaceuticals ruined my health. Leave supplements alone!
Thank you Karen, same here, supplements help with MS; but the shots/drugs did not!
People have the right to have access to nutritional supplements.
`Thank you, thank you, thank you for being on top of this. I take suppliments, and am determined to use naturalpathic means to heal anything I have that needs healing. Plus, with the food supply the way it is today, we need suppliments. The two that are introducing this new legislature fully understand how the American people they supposedly represent feel about their use of suppliments staying free from pharmaceautical big business intervention or they wouldn’t be so sneaky. Thank you again for continuing to keep us aware.
Keep your hands off our supplements.
I’m 82, still work part time – have diabetes plus a few other uncomfortable conditions – however, i manage to work part time, live a full life – 95% I attribute to taking well thought out supplements. my long time physician is respectful of my research & actions. even takes the time to ask me about some items – don’t want anyone playing “god” with my health!
Thank you Eleanor, take care and continue to be strong and well!!
To the extent that supplements are effective, they eat into profits of the medical industrial complex. However, given effective supplements are generally much cheaper than the alternatives, the FDA is exacerbating the already over stressed runaway medical costs. Perhaps this argument can be made to defeat this measure?
If you had any doubt that Nazis runs the US, and that the agenda of the FDA is to keep everybody diseased, perhaps this will wake you up. Or perhaps not. I think some people can’t imagine the true evil that exists in the govt/corporations.
Supper, we’re realizing the negativity and changes taking place happening over time now. It’s frightening isn’t it? But we have to stay strong and stand up for what is right!
I will use supplements. They may become even more expensive, harder to find, more dangerous to buy, and require more research to locate quality, but I will use supplements. My lifestyle and stamina before and after using the supplements that I use are dramatically different. I will use supplements, good ones, effective ones.
I haven’t had an antibiotic the last 28 years. I have only taken supplements for anything that has come up including cat bite. With the help of my alternative medicine doctors over the years. For years from grade school through College i was always sick got everything and was always on antibiotics. I had quite a fungus dew to 10 years to tetracycline through HS and College. I turned away for western Medicine in my 30s and feel better for it. Now I am learning about no Rancid Oils, No GMO food no nitrites or nitrates, to eat only Grass fed animals and pastures raised chickens humanly treated live stock, no farm raised fish only live cough and thank God for Raw milk and other Raw dairy that i can now enjoy as apposed to pasteurized that i was never able to digest all my life. I hope more people will understand we are the best regulators of what we eat, not the government.
The nanny state school principal is at it again.
The FDA doesn’t even have the funding to keep contaminated food off our plates and dangerous drugs out of systems. The FDA admitted in their report Pathway to Global Product Safety and Quality it would take 9 years just to inspect every high-priority pharmaceutical facility alone, let alone those of lower priority and every foreign food facility as well. The plan calls for the FDA to inspect 600 foreign food facilities in the first year and double their inspections each subsequent year. By year 9 that would 153,600 facilities or just under 420 facilities a day.
There’s no way the FDA has the resources to handle additional, unnecessary regulation. Its about time the FDA stopped waging its war on everything consumable, especially vitamins and supplements that have been proven safe and effective time and time again and focused their misguided efforts where it really matters.
Your news letter is written for people who have a lot of time to READ. I don’t!
IT NEEDS TO BE CLEAR AND SPECIFIC ABOUT WHERE TO CLICK TO TAKE ACTION. It isn’t.
I just want to get right to the place where I can comment and send my opinion against the legislation NOW!
If your newsletter had a VERY OBVIOUS PLACE TO GO TO FOR COMMENTS TO SEND IT WOULD BE GREAT!
Your writers have all day to write; that’s their job. Nice, if I have time I will read some.
THE IMPORTANT AND CRITICAL THING IS TO GET OUR COMMENTS TO THE LEGISLATORS.
I could not find where to do that.
At the time this article was published we had not yet published an action alert – this was sent as an emergency update to our readers by email on a Friday. Our action alert appeared in the newsletter that Tuesday. Please click the big red text banner at the top of any page on our site to be taken to the petition.