Senators Give Supplements a Lifeline
January 3, 2012
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Will it be enough to rein in FDA’s outrageous power grab?
ANH-USA, together with a number of supplement trade organizations, went to Capitol Hill to plead our case about the FDA’s profoundly flawed NDI (new supplement) draft guidance in the offices of two powerful senators and longtime friends of natural health, Sen. Tom Harkin (D-IA) and Sen. Orrin Hatch (R-UT). Our visit was preceded by all the letters you have been sending to Congress, which have immeasurably increased the visibility of this issue. As you know, if this draft guidance stands, it would allow FDA to arbitrarily deny the sale of any supplement created (or modified) in the past seventeen years. Immediately after this meeting, Sens. Harkin and Hatch wrote to FDA Commissioner Margaret Hamburg and formally asked the FDA to withdraw its guidance document.
The senators urged FDA to begin work on a new draft that provides needed clarification on what constitutes a New Dietary Ingredient (NDI)—but, in their words, does not undermine Congress’s desire to provide consumers with access to safe, affordable dietary supplement products. Exactly!
These senators were uniquely qualified to make such a request, since they were the principal authors of DSHEA, the Dietary Supplement Health and Education Act of 1994. “When Congress included language in the Food Safety Modernization Act (FSMA) directing FDA to clarify when a dietary supplement ingredient is a new dietary ingredient, the expectation was that the guidance would be consistent with DSHEA,” they write. “Unfortunately, the draft guidance serves to undermine DSHEA in a number of important respects.”
They go on to outline the various arguments that we have been making in these pages for some time:
- The requirement for a manufacturer to submit an NDI notification for every dietary supplement containing an NDI is directly contrary to the language of DSHEA, which requires notification only of the intent to use an NDI;
- This new requirement is burdensome and would impose substantial additional costs on manufacturers, would not provide additional safety benefits, and would undermine access to the safe, affordable nutritional supplements that DSHEA was designed to ensure;
- The NDI guidance’s assertion that synthetic copies of ingredients can never be a dietary ingredient is without any statutory basis, and is contrary to longstanding FDA policy; and
- This guidance is contrary to Congressional intent by grandfathering in only ingredients that were marketed before the enactment of DSHEA—such an argument is particularly specious since “the term dietary supplement wasn’t even defined prior to DSHEA”!
We would like to thank Senators Harkin and Hatch for being such stalwart champions of natural health, and for their leadership in this battle to prevent the FDA from usurping powers that they are not legally entitled to. We also want to thank every one of you for contacting Congress and the FDA and being such a vital part of this process.
We aren’t out of the woods yet—we’ll have another update soon with additional action items for you. The time may come for more specific legislative action, and we may find ourselves battling FDA in the courts as well. That’s why your continued support and activism is so terribly important. Together we can win this one, preserve your access to supplements, and keep supplements from costing as much as drugs.
July 26, 2011
Are the NDI guidelines the ultimate FDA tool to freeze dietary supplement innovation? A special report by Robert Verkerk, PhD, ANH-USA Scientific Director and ANH-Europe Executive and Scientific Director.
The Wheels Come Off the Bus on Genetically Engineered Crops!Despite a lack of independent safety testing, the government has seen fit to declare there will be no oversight of a genetically engineered grass. Is this the beginning of a GE avalanche?
| FDA Copies the European Union and Slips In One of its Deadliest Weapons |
July 19, 2011
Launches Attack on Supplement-Protecting Senator—Just as DSHEA Comes under Renewed ThreatTheNew York Times made nasty insinuations about both the supplement industry and Sen. Hatch, one of the two authors of DSHEA—and got the facts completely wrong about ANH-USA.
Should You Have a Say about What Goes On in Your Home?Monopoly utility companies across the country are installing radio frequency “smart meters” in your home. If you don’t want them, too bad: it’s take them or live without electricity. Meanwhile, RF is being investigated as a carcinogen.
Be sure to join us onFacebook andTwitter!
EditorsDeborah A. Ray, MT (ASCP) Craig R. Smith
The Pulse of Natural Health. This newsletter is copyrighted material (© 2011 by Alliance for Natural Health USA) but we hope you will forward, copy, or reprint it without prior authorization. Just remember to note the source and date, and please link to original content on theANH-USA website.
The information inThe Pulse of Natural Health is for educational purposes only and should not be construed as medical advice. Readers are advised to consult a qualified professional about any issue regarding their health and well-being.
| NYT |
“Dietary Supplement Labeling Act” a Huge Smokescreen
July 12, 2011
The FDA is trying to turn a simple notification system for new supplements into a totally arbitrary approval system. Let’s tell the FDA that supplements are not drugs and ask Congress for help!
Disastrous Durbin Bill Finally Online—Help Us Get It Stopped!Sen. Durbin’s disingenuous “Dietary Supplement Labeling Act,” which we told you about last week, needs to be defeated. This week we explain why in greater depth. Tell your senators!
Threat to Texas Chiropractors’ Scope of PracticeThe Texas Board of Chiropractic Examiners (TBCE) wants to greatly limit the scope of chiropractic practice in Texas. Why? A state-based Action Alert.
| FDA Guidelines a Perversion of Congressional Intent |
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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.
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.
We’d also love to hear your comments about this article—just add your thoughts below—but remember that the messages below are only seen by our ANH-USA readers and not your senators or representative.
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TO SEND YOUR MESSAGE TO CONGRESS |
June 28, 2011
Senator Durbin’s bill, which will be introduced in Congress this week, is likely to be another example of burdensome and unnecessary legislation.
Action Alert: FDA Releases Draft Guidance on NanotechnologyWhen is organic not organic? When nanoparticles are involved.
You Did It! You Helped Ban BPA in Delaware!A few weeks ago we issued an Action Alert to help pass an important bill to fight BPA in Delaware. Thanks to your activism, Delaware’s children will be healthier.
State Action Alert: New York Says “Stop Exposing Our CAFOs!”Pending legislation in New York State wants to send investigative journalists to jail for photographing factory farms.
Be sure to join us onFacebook andTwitter!
EditorsDeborah A. Ray, MT (ASCP) Craig R. Smith
The Pulse of Natural Health. This newsletter is copyrighted material (© 2011 by Alliance for Natural Health USA) but we hope you will forward, copy, or reprint it without prior authorization. Just remember to note the source and date, and please link to original content on theANH-USA website.
The information inThe Pulse of Natural Health is for educational purposes only and should not be construed as medical advice. Readers are advised to consult a qualified professional about any issue regarding their health and well-being.
| Dietary Supplement Labeling Act—An ANH-USA Exclusive! |
Dietitians are Buying Coke’s Line: Sugar, Fluoride, Artificial Colors are SAFE for Children!We wish we could say we are surprised. Registered dieticians are now being given formal education by the Coca-Cola Company on how safe its ingredients are.
The European E. Coli Outbreak: The Real StoryHint: It’s not about organic food.
BPA: It’s Time for the Federal Government to Catch Up!The world knows how dangerous BPA is. Even China, following the lead of Europe and Canada, has now banned BPA in baby bottles. In the absence of leadership from the federal government, many states have also started to take action.
EditorsDeborah A. Ray, MT (ASCP) Craig R. Smith
The Pulse of Natural Health. This newsletter is copyrighted material (© 2011 by Alliance for Natural Health USA) but we hope you will forward, copy, or reprint it without prior authorization. Just remember to note the source and date, and please link to original content on theANH-USA website.
The information inThe Pulse of Natural Health is for educational purposes only and should not be construed as medical advice. Readers are advised to consult a qualified professional about any issue regarding their health and well-being.
| June 14,
2011 |
APRIL 26, 2011
ANH-USA Is Taking On the FTC!The Federal Trade Commission has recently created new and arbitrary requirements for ANY food or dietary supplement health-related claim—and is enforcing them—in direct violation of federal law. Help us fight this new censorship of science all the way by taking action to support our Citizen Petition!
New Vaccine Legislation in the States We have a number of new state-level Action Alerts on vaccine-related legislation for you—some bills expand your freedoms, some restrict them, and one even wants to vaccinate your food!
Vaccine Mania The vaccination question is a hotly debated topic, even in the natural health community. It doesn't help when government and vaccine companies get in bed together, scientists have blatant conflicts of interest, and research results may be tainted.
Be sure to join us on Facebook and Twitter!
EditorsDeborah A. Ray, MT (ASCP) Craig R. Smith
The Pulse of Natural Health. This newsletter is copyrighted material (© 2011 by Alliance for Natural Health USA) but we hope you will forward, copy, or reprint it without prior authorization. Just remember to note the source and date, and please link to original content on the ANH-USA website.
The information in The Pulse of Natural Health is for educational purposes only and should not be construed as medical advice. Readers are advised to consult a qualified professional about any issue regarding their health and well-being.
April 12, 2011
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A message from the Alliance for Natural Health USA |
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Urgent
Action Alert: The Leahy Bill is BACK! |
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(1) introduce or deliver for introduction into interstate commerce
any food that is adulterated or misbranded; or
(2) adulterate or misbrand any food in interstate commerce.
The big sticking points were the way FDA defines “adulterated” or
“misbranded,” and the fact that the bill originally didn’t require
there be any intent to harm—so that a paperwork error could be
treated just as harshly as a corporation that knowingly sells
tainted food.
Working with Congressional leaders, we were successful in getting
the language changed so that “with conscious or reckless disregard
of a risk of death or serious bodily injury” was included. This
wasn’t perfect, since the FDA could claim any intent it wants
to—better to require actual harm of at least some kind. And the
problematic “adulterated” or “misbranded” terminology remained.
Fortunately our readers and others took action and the bill
died.
Now the bill has been re-introduced in the Senate as S.216.
Thelanguage is better.
First, the jail term now is for violators of specific sections of
the Federal Food, Drug, and Cosmetic Act (FD&C)
whoknowingly
and intentionally defraud
or misleadand
do
sowith
conscious or reckless disregard of
a risk of death or serious bodily injury. And second, the jail term
applies to food violations, which the Senate Judiciary staff
confirmed with ANH-USA would in this instance exclude dietary
supplements, although based on their past behavior the FDA may not
interpret it that way.
In addition to the risk that the FDA will interpret this bill in
whatever way it wishes, a risk that could be fixed with more
explicit language, there is a further major problem.
“Adulterated
or misbranded”
The
bill hangs on the “adulterated or misbranded” language in the
FD&C Act, language that is so vague as to be absurd. To our
ears, “misbranded” suggests deliberate misstatements about the
contents or efficacy of a product. But in the FD&C
Act,“misbranding” (section 403)
takes
on a completely different meaning. It can mean that the producer
makes a completely true statement about the product but without FDA
permission.
The Act specifically says that misbranding has occurred if a claim
is made on the food label, which characterizes the relationship of
a nutrient to a disease or a health-related condition. Here’s an
example: research from Harvard suggested that cherries could reduce
heart attack risk. FDA did not allow cherry producers, sellers, or
manufacturers to talk about that research, andsent a cease-and-desist letter to twenty-nine
companies telling
them to stop making claims about these health benefits or face
fines and jail. At least in this instance, the FDA could not
threaten a ten-year jail sentence.
Only after a food or ingredient is taken through the New Drug
Approval process can a manufacturer educate consumers about the
potential of the supplement or food to prevent or treat disease.
This is an expensive process—and since food and dietary supplements
are natural they cannot be patent protected, which means
manufacturers could never hope to recoup the millions (sometimes
billions) of dollars necessary to go through the NDA process. Food
manufacturers cannot even cite legitimate peer-reviewed science on
their website without being guilty of misbranding—and thus subject
to up to ten years in prison.
The other word is “adulterated.” To most people, it means that a
product doesn’t meet good manufacturing practices, that the
supplement itself is somehow tainted or injurious to health, or
contains an ingredient that presents a significant risk of illness.
But under the FD&C Act,“adulteration (section 402)”
says
that a dietary supplement is considered adulterated if it does not
follow “current good manufacturing practices” (CGMPs)—which are
extremely broad, even containing such minor provisions as
record-keeping practices. In other words, the FDA could threaten a
ten-year jail sentence for minor paperwork errors if the agency
took the position that the bill did apply to supplements.
Would the FDA actually try to send someone to jail for ten years,
using the new bills’ expanded jail time, for citing science or for
paperwork errors? As unlikely as it might seem, the Agency’s past
behavior suggests that they would at least threaten it to get food
or supplement producers to sign draconian consent
decrees.
Where
do we go from here?
We
would support the Leahy bill if an amendment is offered which
addresses its current vagueness and which also carves out certain
exemptions in the definition of misbranding and adulteration, or
better yet, defines them anew instead of referring to the extremely
broad and vague FD&C Act.
We fear that the vague language and ten-year jail term in the bill
will be misused by the FDA to threaten innocent natural health food
and dietary supplement producers.Please
contact your senators immediately (and representatives too) and ask
them to amend or stop this bill.
TO
SEND YOUR MESSAGE TO CONGRESS
Click
THIS LINK to
go to the Action Alert page. Once there, fill out the form with
your name and address, etc., and customize your letter. We have a
suggested message for you, but please feel free to add your own
comments to the letter.
We’d also love to hear your comments about this article—just add
your thoughts below—but remember that the messages below are only
seen by our ANH-USA readers and not Congress, the FDA,
etc.
We’re thrilled to announce that thanks to your calls and letters,
the Senate Food Safety bill (S. 510) willnot
include those
obscene ten-year jail sentences for food and supplement
manufacturers who violate complicated FDA rules. Senate offices
were deluged with your messages, and the Senate leadership listened
to you!
Sen. Tom Harkin (D-IA) is the manager of S. 510. He has pulled
together what is called a Manager’s Amendment, which will replace
S. 510; that package does not include the language from Sen.
Leahy’s bill. There was a unanimous consent agreement in the Senate
on Wednesday as to what amendments will or will not be raised when
the bill is debated on Monday, November 29. Senate Majority Leader
Harry Reid (D-NV) says they have agreed to “up to five” amendments,
mostly procedural, and ANH-USA has been assured by Sen. Harkin’s
office that Sen. Leahy’s bill is not among them. Neither the bill
nor its language can be considered without another unanimous
consent vote by the entire Senate, so that issue is now dead.
ANH-USA has further learned that Sen. Hatch worked with Sen. Leahy
to remove a section from the Leahy bill that specifically targeted
supplements and made a lapse in filing to the FDA subject to the
full ten-year jail term (see the reference to subsection V of
Section 301 of the Federal Food and Drug Act). This is
important, because this was the worst part of the bill, and Sen.
Leahy could attempt to pass his bill again, either during the Lame
Duck session or in the next Congress. We are grateful to Sen.
Hatch and Sen. Leahy for working together to remove this
provision.
This is thesecond S. 510 victory for ANH-USA
members and allies. You may remember that last year we were able to
make sure the bill did not require the development of a plan to
harmonize with the Codex Alimentarius, which would have reduced
access to higher, therapeutic doses of nutrients in dietary
supplements.
We’re pleased that now no one will be putting small food and
supplement producers (even mom-and-pop operations) in jail for ten
years simply for running afoul of mindlessly complex FDA rules.
This is an exciting day for natural health and health
freedom.
Some background, for readers who haven’t been following the bill’s
progress as closely:
The House version of the Food Safety bill passed some time ago.
That bill includes draconian ten-year jail terms for even minor
paperwork violations. Long jail terms were explicitly rejected by
the Senate committee that put together the Senate’s version of the
bill. But Sen. Patrick Leahy (D-VT) introduced his own bill, the
Food Safety Accountability Act (S. 3767). This bill adds back the
ten-year jail terms for adulterating or misbranding food.
Bear in mind, the FDA defines those terms in its own way. In the
FDA’s view, “adulteration” includes recordkeeping violations, while
“misbranding” includes citing peer-reviewed science about the
benefits of a dietary supplement. This new threat of sanctions
would have given the FDA a hammer with which to threaten and coerce
companies engaging in completely legal activities.
Sen. Leahy subsequently amended his bill to reserve the jail terms
for someone who “consciously or recklessly disregard[s] a risk of
death or serious bodily injury.” But of course, what is conscious
or unconscious, intentional or unintentional, is to be decided by
FDA prosecutors. Noactual
harm
is necessary!
The good news is that with the help of people like you, who were
willing to speak out on what they considered an unjust threat, we
were able to keep the Leahy language out of S. 510. Thank you—this
victory belongs to all of us!
Sincerely,Gretchen DuBeau Executive Director
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Emergency Action Alert on Leahy Food Safety Bill
It is touch-and-go whether we can keep that provision out of the Senate Food Safety bill (S. 510). Please contact your senators immediately, even if you have done so before!
(11/19/10)
Read More »
Please Help Us Stop The Leahy Food Safety Bill
Congress is back in session, and the sleeper in the Senate is Senator Leahy’s Food Safety Enhancement Act (S.3767), poised to pass in the very near future unless you help us stop it now.
(11/16/10)
Read More »
Also Watch Out for an Omnibus Bill
This lame duck session of Congress has other risks for natural health.
(11/16/10)
Read More »
Is the FDA Planning an Unpleasant Surprise?
We know that the FDA is discussing new regulatory requirements for supplements.
(11/16/10)
Read More »
The Disappearing Honeybee and More Dirty Dealing by Major Drug Companies
Natural health diets depend completely on the honeybee. Industry money infiltrates science once again, as the likeliest culprit behind the worldwide collapse of bee colonies is revealed—and it’s not what the New York Times reported!
(11/16/10)
Read More »
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