New US bill on supplement ingredients proposed
Legislation has been introduced in the US House of Representatives which would establish a strict regime of controls on products containing herbs and other ingredients that are not vitamins and minerals.
Michael McGuffin, the president of the American Herbal Products Association (AHPA) says that the burden of the controls that are proposed for herbs exceeds comparable burden on drugs.
Update July 2005:
This bill was re-introduced on 30 June 2005 as HR 3156 after it died with the previous legislature.
H.R. 3156 To Tighten Supplement Safety Rules - But Why Only Supplements?AHPA Update
October 31, 2003Waxman / Dingell / Davis Introduce New Supplement Bill
- Legislation Targets Herbs and other Non-nutritive Ingredients -Congresswoman Susan Davis (D-CA), joined by Henry Waxman (D-CA) and John Dingell (D-MI), introduced legislation in the House of Representatives on Tuesday that would amend the Federal Food, Drug and Cosmetic Act in several ways that would impact marketers of herbal dietary supplements.
The bill, identified as the Dietary Supplement Access and Awareness Act (H.R. 3377), excludes dietary supplements that consist only of vitamin and/or mineral ingredients from its provisions. The bill applies only to the other ingredients defined by the Dietary Supplement Health and Education Act (DSHEA), including herbs, amino acids, and the ingredients described in DSHEA as "dietary substance(s) used by man to supplement the diet by increasing the total dietary intake."
The legislation would establish a number of new requirements for marketers and new authorities for the Food and Drug Administration, (The legislation identifies the Secretary of Health and Human Services rather than FDA in each of these new authorities, but FDA would, in fact, be charged with these responsibilities) including:* a requirement for all manufacturers and processors of the affected dietary supplements to provide to FDA and to update every six months:
o a list of all products;
o labeling for each product;
o a listing of all "major ingredients... including active ingredients, as applicable);"
o at the discretion of FDA, a quantitative listing of all ingredients;* a requirement for manufacturers and distributors of these products, unless specifically waived by FDA, to report serious adverse events to FDA within 15 days of receipt, to investigate any such reports, and to maintain certain records;
* new authority for FDA to order a manufacturer to conduct postmarket surveillance of supplements for which there is "a reasonable possibility...[of] serious adverse health consequences;"
* new authority for FDA to require a manufacturer to demonstrate safety of a supplement if the agency has "reasonable grounds for believing" that the supplement presents a significant or unreasonable risk of illness or injury or is an imminent hazard to public health or safety;
* new authority for FDA to establish criteria for determining that a supplement may pose a significant risk to minors and for deeming the act of selling such product to minors as misbranding.
"AHPA has long stated its belief that submission of serious adverse event reports should be mandatory for supplements," stated Michael McGuffin, AHPA's President, "but it appears as if this bill fails to provide the protections to industry that are established by law for adverse event submissions by drug companies. Also, the idea of a product registration is one that may deserve discussion and cost evaluation, but Representative Davis should first explain why the proposed semi-annual burden for supplements should exceed the annual burden for drugs. In addition, the subjective nature of FDA decision making for each of their proposed new authorities must be challenged."
In addition, the bill would provide funding to educate health professionals on the importance of reporting adverse health experiences associated with dietary supplements to FDA, and to educate consumers about the importance of informing their health professionals of the dietary supplements and drugs they are taking. It would also strike language from the current law, as amended by DSHEA, which states that the burden of proof is on the federal government for showing that a supplement is adulterated.
The bill has been referred to the House Committee on Energy and Commerce, the site of a recent hearing on ephedra that led to its Chairman, Billy Tauzin (R-LA), to state on the House floor the following day, "I voted wrong in 1994" in supporting DSHEA.
- - -
For some information regarding an earlier proposal (S 722) and yet another one (S 1538) being discussed, see the following article by Jenny Thompson of the Baltimore Health Sciences Institute.Under the Gun
Health Sciences Institute e-Alert
November 10, 2003
**************************************************************
Dear Reader,
When your back is to the wall, it's good to have options.
And we now have an option.
In the e-Alert "The Fix Is In" (7/22/03) I told you about the senate bill (S. 722) designed to broadly expand the FDA's authority to control the dietary supplement market. If passed, this bill could seriously inhibit your freedom to make your own health care decisions.
But now a new bill has been introduced in the Senate (S. 1538), which challenges the need for S. 722, while strengthening the 1994 legislation that was specifically designed to help protect the supplement industry from unnecessary constraints in the first place.
These two bills are expected be voted on soon, so now is the time to let our congressmen know that S. 1538 is the voice of reason in the dietary supplement debate.
-------------------------------------------------------------
Unnecessary and overreaching
-------------------------------------------------------------If passed in its current form, S. 722 (titled "Dietary Supplement Safety Act of 2003") will give the FDA sweeping new powers.
For instance, under S. 722, FDA officials would have the ability to remove an entire class of supplements from the market in response to the filing of only one serious adverse reaction complaint - even if the complaint was filed by someone who used the supplement in contradiction to the instructions and warnings of the manufacturer.
In such a case, supplement makers would then be required to demonstrate the safety of their products; a process that would put a heavy financial burden on accused manufacturers - heavy enough to drive some out of business. For those supplements that did reach the evaluation stage, the FDA would set the standards for the evaluations and then determine if the standards were met. In effect, the FDA would act as prosecutor, judge, and jury, while accused manufacturers would be forced to pay the bill against a stacked deck.
The sponsor of S. 722 - Senator Dick Durbin - says his bill will "save lives and restore America's confidence in the use of dietary supplements."
First: With dietary supplement sales at an all time high, American's are displaying a growing confidence in their use of supplements, not a lack of it. And second: It's simply naïve to think that additional regulations will save lives when the current regulations that promise safety for prescription drug users are powerless to prevent thousands of drug-related deaths every year.
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The alternative
-------------------------------------------------------------Think of S. 722 is a staging area from which the FDA will have the opportunity to dismantle the dietary supplement freedom that we've enjoyed for almost a decade under the Dietary Supplement
Health and Education Act (DSHEA).In a nutshell, DSHEA classifies and regulates dietary supplements as food. Under DSHEA, the FDA and the FTC regulate the manufacturing of supplements, as well as labeling and advertising. And yet critics of DSHEA would have you believe that the act doesn't regulate supplements at all. What they're really saying is that DSHEA doesn't regulate supplements in the same way that drugs are regulated. In fact, DSHEA has been a boon for the supplement industry, by not hampering the
manufacture of supplements with unnecessary regulations.This is where the new Senate Bill 1538 comes in. Titled "DSHEA Full Implementation and Enforcement Act," S. 1538 was introduced by senators Tom Harkin and Orrin Hatch to help strengthen DSHEA, making S. 722 irrelevant.
Under S. 1538, the FDA would receive additional funding to ensure that DSHEA is fully carried out, as originally intended. The new bill also increases funding for dietary supplement research and consumer information through the National Institutes of Health.
As many e-Alert readers are aware, I'm no fan of regulations and I don't believe that the best way to solve problems is to throw money at them. But I do believe that DSHEA provides more than enough regulation of dietary supplements. Therefore, S. 1538 offers a reasonable and responsible alternative to the completely unnecessary extremes of S. 722.
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Exercise your voice
-------------------------------------------------------------Predicting how and when Congress might act is a longer shot than predicting the stock market. But it appears that both S. 722 and S. 1538 may come before the Senate for a vote in the next few weeks. So the time to act is now. I strongly urge you to join me in taking a moment to send a brief letter or e-mail to your Senators. (You can easily find Congressional street addresses and e-mail addresses at congress.org just by entering your zip code. We've heard that snail mail gets more attention from our
public servants than e-mail.)Tell your Senators that you strongly support S. 1538 ("DSHEA Full Implementation and Enforcement Act") which will provide all the funding necessary to insure consumer protection under DSHEA. Tell them you hope they'll support S. 1538, while also opposingS. 722 ("Dietary Supplement Safety Act of 2003"), which willonly limit our freedom to make our own health care choices withthe responsible use of dietary supplements.
And please ask your friends and family to help get the word out about these two important bills. Nothing less than the future of our health care freedom is at stake.
Here an article received by way of Mayday - Denmark.
New bill to overhaul DSHEA regulation of herbal supplements
11/04/03 - Legislation that would significantly increase the costs of marketing herbal dietary supplements was introduced in the House of Representatives last week, designed to better prevent adverse events caused by herbal ingredients.The bill, called the Dietary Supplement Access and Awareness Act (HR 3377), is sponsored by Susan Davis (D-CA), Henry Waxman (D-CA) and John Dingell (D-MI). It excludes dietary supplements that consist only of vitamin and/or mineral ingredients but applies to other ingredients defined by the Dietary Supplement Health and Education Act (DSHEA), including herbs, amino acids, and the ingredients described in DSHEA as Ã…'dietary substance(s) used by man to supplement the diet by increasing the total dietary intake‚.
The legislation would require all manufacturers and processors of the mentioned supplements to provide a list of all their products and all active ingredients used, and the labeling of each product to the FDA, to be updated every six months.
It also demands that manufacturers and distributors of these products, unless specifically waived by FDA, report serious adverse events to FDA within 15 days of receipt, to investigate any such reports, and to maintain certain records.
Finally the FDA would be given new authority to react to safety risks. It would be able to order a manufacturer to conduct postmarket surveillance of supplements for which there is "a reasonable possibility...[of] serious adverse health consequences‚. FDA could also require a manufacturer to demonstrate safety of a supplement if the agency has Ã…'reasonable grounds for believing‚ that the supplement presents a significant or unreasonable risk of illness or injury or is an imminent hazard to public health or safety.
New authority for FDA to establish criteria for determining that a supplement may pose a significant risk to minors and for deeming the act of selling such product to minors as misbranding has also been tabled.
"AHPA has long stated its belief that submission of serious adverse event reports should be mandatory for supplements but it appears as if this bill fails to provide the protections to industry that are established by law for adverse event submissions by drug companies," said Michael McGuffin, president of the American Herbal Products Association (AHPA).
„Also, the idea of a product registration is one that may deserve discussion and cost evaluation, but Representative Davis should first explain why the proposed semi-annual burden for supplements should exceed the annual burden for drugs. In addition, the subjective nature of FDA decision making for each of their proposed new authorities must be challenged," he added.
In addition, the bill would provide funding to educate health professionals on the importance of reporting adverse health experiences associated with dietary supplements to FDA, and to educate consumers about the importance of informing their health professionals of the dietary supplements and drugs they are taking.
It would also strike language from the current law, as amended by DSHEA, which states that the burden of proof is on the federal government for showing that a supplement is adulterated.
The bill has been referred to the House Committee on Energy and Commerce.
See also a report on a recent hearing:Subcommittee hearing: "10 Years After the Implementation of DSHEA
and a site that tells you how you can help...
a recent article to show that supplement ingredients ARE being policed by the FDA, contrary to the impression that is being made by a campaign for new restrictive laws:
Ten Year-old Dietary Supplement Law Keeps Potentially Unsafe Ingredients from Market
FDA has rejected 70 percent of new herbsJuly 2005 - This bill, which expired with the legislature, has now been re-presented, apparently in an even worse incarnation. See Chris Gupta's article:
They Are Back At It Again! Protect DSHEA, Oppose HR 3156
"Do you remember HR 3377, Dietary Supplement Access and Awareness Act (also called the "Son of Durbin" bill) from the 108th Congress? Well, it's back and they've done the "unthinkable" - they made it even worse!"....
posted by Sepp Hasslberger on Friday November 7 2003
updated on Tuesday December 7 2010URL of this article:
http://www.newmediaexplorer.org/sepp/2003/11/07/new_us_bill_on_supplement_ingredients_proposed.htm
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