This new bill pretends to be consumer-oriented but instead will give the FDA new powers it could easily misuse, restricting your access to supplements and raising the cost of buying them. An important new Action Alert for Congress!
Last week, Sen. Dick Durbin (D-IL) introduced S.1310. The Dietary Supplement Labeling Act would create new and burdensome regulations for supplement manufacturers—supposedly in an effort to protect supplement consumers. As we have said before, the FDA already has the power to protect consumers. In many cases, it does not choose to use these powers. Giving the agency even more power, especially murky powers that could easily be misused, will not make the situation better.
The bill has already been filed but the text is not yet available online as it should be. You can read an advance draft copy of the bill on our website.
As we reported just before the bill was introduced, the bill is disingenuous. It was purportedly created in response to the recent “Lazy Cakes” brownie controversy we told you about (the brownies contained melatonin). Lazy Cakes was unarguably a food product sold by a renegade food company. But this bill targets supplements and supplement manufacturers. Basically the bill exploits a hot-button food issue to try to pass more regulation for dietary supplements.
There is hardly any mention in this bill of food companies like the one that made the Lazy Cakes. In fact, the only reference comes at the very end of the bill, where it requires the FDA establish a definition for the term “conventional food.” But the FDA has already written draft guidance setting out the difference between dietary supplements and beverages and clarifies what “cannot be represented for use as a conventional food” means. The Agency has been sitting on this since 2009!
Durbin’s bill requires that the FDA, together with the government’s Institute of Medicine (IOM), compile a list of dietary ingredients (read: supplements) that could lead to adverse events or are otherwise deemed risky in some way. Dietary supplement manufacturers would have to put mandatory warnings on labels for any ingredient on this list. This sounds a lot better than it is for a number of reasons:
- Government-mandated warnings on labels could say anything the government wants them to say, no matter how unreasonable, and could be of any length, even if the packaging became prohibitively expensive. Essentially we don’t know what we are getting into here.
- The FDA is historically biased against supplements. The IOM is no better. Just look at the IOM’s recent report on vitamin D. This report willfully threw out most of the research on vitamin D and was altered at the last minute to reduce the upper limit of what is considered safe. Even conventional medical societies such as the American Association of Clinical Endocrinologists roundly condemned the report. Also because of some notorious conflicts of interest, the IOM is hardly the authority to determine what is safe and what isn’t.
- Creating lists of “bad” ingredients or “bad” doses based on completely arbitrary or non-existent standards is a slippery slope. It could be used as a hammer by the FDA to go after supplement companies. It could easily lead to European-style standards being applied here in the US. Remember those standards? If a beta carotene capsule contains more beta carotene than is in half a large carrot, it is banned.
- The safety of a new dietary ingredient (that is, new supplement) is already covered through the NDI notification process (see our article on NDIs in this issue). Why create new and confusing new legislation about the same thing?
- Under the Durbin bill, once an ingredient or supplement is on the list, there is no clear process to challenge the FDA and IOM determination, not even if new or contradictory evidence comes to light.
- Under existing law, all supplement facilities have to register with the FDA. Under this new bill, all facilities must also include a description of each dietary supplement product manufactured at that facility, a list of all ingredients in each dietary supplement, and a copy of the label and labeling for each product. Dietary supplements are already subject to many reporting and labeling requirements, so this bill’s requirements are just redundant.
Note that DSHEA—the Dietary Supplement Health and Education Act of 1994—already requires that all dietary supplement products show ingredient lists. Health claims already have to be pre-approved by the FDA according to the Nutrition Labeling and Education Act. Supplements must be manufactured under Good Manufacturing Practices to ensure the ingredients are safe and at the levels they claim them to be. Accurate disclosure of the contents in the dietary supplement package is already required under the Fair Packaging and Labeling Act. And almost all supplement manufacturers have a list of all their products and ingredients available to the public on their websites.
In other words, this bill creates extraneous red tape, paperwork, and burdensome labeling requirements when everything the bill mandates is already being accomplished under current law! All Sen. Durbin’s “Dietary Supplement Labeling Act” will do is make it more expensive to manufacture supplements and dampen innovation. The protections it provides consumers are very small, and if interpreted arbitrarily or unfairly, could be detrimental.
Furthermore, if the FDA is having trouble enforce existing legislation, it makes no sense to create new laws for the agency to enforce—especially since Congress is considering cutting their budget!
It would be easy for Congress to be taken in by this bill. Let’s insist on Congress looking at the facts of the case. Remember that Congress assumes that every message they receive reflects a far larger number of concerned voters. Please take a moment to send in your message now.
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TO SEND YOUR MESSAGE TO CONGRESS |
Websites need to redesign for overseas Americans who may vote in their former residence district and state for federal election. There should be a selection for Overseas American.
I will post this on my Facebook page, tweet, and keep people updated on my site http://www.drtchiro.com. Thanks for keeping me updated.
Thank you for protecting our supplement rights. Greatly appreciated! Sincerely, Gena Bouquet
Stop the BS !!
I think the fda should be defunded. A new form of the fda should come into effect. One that
is honest and cares about people Th fda as we know it only cares about how much money it
can bring in for the drug companies not about wether a drug is harmful or not. I have been taking
vitamins and other suppliments for years and am on no drugs and the drug companies can’t stand that. They wany to controll as much as they can just like with obamacare.
I agree with you 100%. The FDA wants to have a monopoly on our health. They cannot stand to have any competition and they will stop at nothing to achieve what they set out to do.
We live in the United States, and we should have complete control over our own bodies, and the government has no right to take away our G-d given right to good health.
The drug companies are losing money, because people are finally getting smart, and looking into natural alternatives to drugs which cure nothing.
Leave our supplements alone NOW and ALWAYS
I appreciate your newsletter and especially this one.
Willis
I think this article is excellent in its talking points and you all do a great job educating us about what
is, what isn’t, and giving a suggested action. We truly need organizations like this!! Thank you
for the work you do.
Please do not create added red tape for the manufactures of our supplements.
Diane bourdeau
Where is the “let freedom ring” anymore in this country. Are we so stupid that we can not make our own personal decisions and take responsibility for them? I want to be able to buy my supplements at a reasonable price. They are helping me tremendously and there are no pharmaceuticals that can help without major side effects as well as ins. and a physician’s prescription. Please do not let them pass this. Thanks.
Please, don’t pass this bill or any other bill that puts any kind of restraint on Natural Foods or Supplements. Due to the pitiful nutritional value of the factory farmed foods and especially processed and restaurant foods, we need to be able to put these nutrients into our diets.
We are ADULTS responsible for our own care (HIPPA) We have a right to make chooses and should do our own education with consulting with a MD if there are multiple Health issues. It is explaines on most Dieatary supplements. Why are you interferring with our choices and trying to control what is our right to choose what we think is best. It’s very clear it’s that that there should be guidlines that protect the consumer But to whose expense It ends on the consumer! Higher prices.. What else LIFE DOES NOT HAVE TO BE SO COMPLICATED. Health issues will be knocking @ your door someday too.
Leave our supplements alone. They should not be controlled by a government body, monitored maybe but not controlled. We are having a hard enough time trying to stay healthy with all the junk that is put into our food or done to our food. The FDA okays meds that are dangers and wants to take away our rights to help our selves. What is happening to our free country?
I went to war for freedom and the gov. Spit in my face and our forefathers americans should take to the streets in protest!!!!
Oh, but it’s against the rules to say “NO GMO” on products? And it’s OK NOT to identify GMO corn, salmon, soy, alfalpha, sugar beets, canola, or indentify it in other products that are made with derivities of those GMO ingredients? GO AWAY CONGRESS….WE’VE HAD ENOUGH OF YOUR LAWS, which are actually written by the entities you are minions for!
I have been taking supplements for the last 50yrs & counting. I have gotten nothing but
positive results. The FDA needs to get their act together & start working on these drug
companies & get rid of ALL the drugs that are NOW killing people rather than ignore them.
Even more important, get rid of ALL the Lobiest that are keeping everyone’s pockets FULL but
yet nobody knows nothing. You people are supposed to keep the American People SAFE rather
than a bunch of (ZOMBIS) walking around.
I know a lot more than this but this is enough for now.
Stop cutting the people out of anything that is healthy to ONLY serve corporate America.
Please pay attention to the people who only want to stay healthy
the FDA does not need any more power .the consumer will manage .they have in the past.
the FDA does not need any more power .the consumer will manage .they have in the past.
the FDA does not need any more power .the consumer will manage .they have in the past.
the FDA does not need any more power .the consumer will manage .they have in the past.
the FDA does not need any more power .the consumer will manage .they have in the past.
the FDA does not need any more power .the consumer will manage .they have in the past.
I am so angry at our government! Their arrogance is hard to put your mind around. Do they think we are too stupid to make our own decisions, our own choices? We really need to be very careful who we put into office and learn to hear between their lines.
The members that make up our government are living lavish lifestyles on the backs of us, taxpayers. They need to stay out of our lives and tell us how to live our lives.
This has been the Land of the Free and the Home of the Brave, but leave it to our government to take those freedoms away.
So I think we all know that not all supplements are created equal. Would this type of bill just force the Sam Clubs to not be able to mass market crap supplements that give professional supplements a bad name? I am not suggesting I want the FDA involved, but if they are involved and get the crap things off the market, like all the bogus, “loss weight with this magic cream type of supplements”, I would be in favor. I guess I need more info about this.
The irony is that the FDA’s proposed new rules and Durbin’s bill do NOT require these same draconian requirements if the ingredients are SYNTHETIC!!! So the ‘crap’ vitamins will have a free ride!
According to the FDA we have no actual right to choose what we eat. In an excerpt from the briefing to the supreme court case: Farm-To-Consumer Legal Defense Fund vs. the United States Department of Health and Human Services the FDA implicitly stated the American public’s “claim to a fundamental privacy interest in obtaining ‘foods of their own choice’ for themselves and their families is without merit.” In other words, we don’t actually have the right to choose what we eat. Furthermore, the American public has no generalized right to bodily or physical health.
Instead of waging war against everything edible, shouldn’t FDA let us consume what we choose, and prevent us from consuming dangerous products that we’ve been told are safe and healthy? By leaving part of this process up the American public, natural selection would weed out a lot of the lesser evils of the food industry. Perhaps its time the FDA cast a smaller regulatory net and focuses its resources where it counts.
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.
The FDA needs to focus on keeping contaminated foods off our plates and dangerous drugs out of our systems.
As soon as you mention DSHEA you lose credibility. DSHEA made it far more difficult for the FDA and the FTC to regulate this commonly fraudulent industry. Why don’t you all go have a look on consumerlabs.com – you’ll find that a massive number of supplements are tainted or have short-sold their customers by overstating active ingredients.
You make it sound like the government is out to get you when they put any regulation on you.
Terrible Terrible Terrible Rhetoric.
This is on fraudulent industry
Who bets this post gets deleted?
very misleading article that is obviously self-serving and laced with rhetoric trying to make it sound like the government is out to ruin your industry. just be happy you have corrupt politicians like Orrin hatch to pass bills like DSHEA in the first place… god-forbid we had safety standards like Europe so that you don’t have to be an expert or read consumer reports in order to not take something that will harm you.