FDA Food Safety Modernization Act

Discussion in 'Men's Health Forum' started by Michael Scally MD, Dec 1, 2010.

  1. Michael Scally MD

    Michael Scally MD Doctor of Medicine

    Text of S. 510: FDA Food Safety Modernization Act
    Read The Bill: S. 510 - GovTrack.us


    (a) In General- Section 413 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 350b) is amended--

    (1) by redesignating subsection (c) as subsection (d); and

    (2) by inserting after subsection (b) the following:

    ‘(c) Notification-

    ‘(1) IN GENERAL- If the Secretary determines that the information in a new dietary ingredient notification submitted under this section for an article purported to be a new dietary ingredient is inadequate to establish that a dietary supplement containing such article will reasonably be expected to be safe because the article may be, or may contain, an anabolic steroid or an analogue of an anabolic steroid, the Secretary shall notify the Drug Enforcement Administration of such determination. Such notification by the Secretary shall include, at a minimum, the name of the dietary supplement or article, the name of the person or persons who marketed the product or made the submission of information regarding the article to the Secretary under this section, and any contact information for such person or persons that the Secretary has.

    ‘(2) DEFINITIONS- For purposes of this subsection--

    ‘(A) the term ‘anabolic steroid’ has the meaning given such term in section 102(41) of the Controlled Substances Act; and

    ‘(B) the term ‘analogue of an anabolic steroid’ means a substance whose chemical structure is substantially similar to the chemical structure of an anabolic steroid.’.

    (b) Guidance- Not later than 180 days after the date of enactment of this Act, the Secretary shall publish guidance that clarifies when a dietary supplement ingredient is a new dietary ingredient, when the manufacturer or distributor of a dietary ingredient or dietary supplement should provide the Secretary with information as described in section 413(a)(2) of the Federal Food, Drug, and Cosmetic Act, the evidence needed to document the safety of new dietary ingredients, and appropriate methods for establishing the identify of a new dietary ingredient.
    Last edited: Dec 1, 2010
  2. Millard Baker

    Millard Baker Member

    The US government gives some $10 million a year to non-governmental, nonprofit organization USADA to keep athletes from doping. Then, USADA creates another group, Supplement Safety Now (SSN), to lobby Congress to change supplement regulation for general public. Is this a proper use of taxpayer funds?

  3. Michael Scally MD

    Michael Scally MD Doctor of Medicine

    Constitutional provision jeopardizes sweeping food safety bill
    Constitutional provision jeopardizes sweeping food safety bill

    By Lyndsey Layton
    Washington Post Staff Writer
    Thursday, December 2, 2010; A02

    A procedural problem is threatening to derail a landmark food safety measure passed by the Senate on Tuesday, sending congressional leaders scrambling to figure out a way to get the bill enacted into law by the end of the lame-duck session this month.

    The legislation, which would give vast new authority to the Food and Drug Administration and is designed to reduce nationwide outbreaks of food-borne illness, has wide public support. The House passed a more stringent version more than a year ago, and before House leaders knew about the procedural problem, they indicated the House would accept the Senate version. President Obama has said he would sign the bill into law.

    But after the Senate approved the measure, 73 to 25, staffers learned one section could violate a constitutional provision that calls for any new taxes to originate in the House rather than the Senate.

    The section in question would impose fees on importers, and on farmers and food processors whose food is recalled because of contamination. If it is determined that those fees amount to taxes, it would essentially nullify the vote by the Senate. The House Ways and Means Committee decides whether the fees are equivalent to taxes.

    House leaders met behind closed doors Wednesday seeking a way to save the bill.

    Afterward, Majority Leader Steny H. Hoyer (D-Md.) voiced frustration to reporters. "This has happened to us four or five times with the Senate," Hoyer said. "The Senate knows this rule and should follow this rule. They should be cognizant of the rule. Nobody ought to be surprised by this rule. It's in the Constitution. And they've all been lectured, and we have as well, about reading the Constitution."

    Several parliamentary maneuvers could get the bill back on track, but nearly all would require the Senate to take another vote on the bill. That is a challenging proposition given the Senate's compressed agenda for the remaining four weeks, which includes passing a continuing resolution to fund the federal government and taking up a measure to extend the Bush-era tax cuts.

    Senate Republicans complicated that scenario Wednesday by sending a letter to Majority Leader Harry M. Reid (D-Nev.) in which they promised to block any legislation in the lame-duck session that does not extend tax cuts or fund the government.
  4. Michael Scally MD

    Michael Scally MD Doctor of Medicine

    Democrats attempt to revive food safety bill
    Democrats attempt to revive food safety bill

    WASHINGTON -- Food safety legislation stalled by a constitutional snag could be revived as part of a giant year-end budget bill.

    The bill to increase the Food and Drug Administration's powers to keep food safe stalled after overwhelmingly passing the Senate last week. House Democrats said after it passed that the bill contains fees that are considered tax provisions, which under the Constitution must originate in the House.

    House Democrats are attempting to fix the problem by adding the legislation to a catchall spending bill unveiled early Wednesday.

    The food safety bill would increase FDA inspections of food facilities, place stricter standards on imported foods and give the agency broader authority to order a recall.
  5. Michael Scally MD

    Michael Scally MD Doctor of Medicine

    Food Safety Bill Passes Senate By Unanimous Consent
    Food Safety Bill Passes Senate By Unanimous Consent

    WASHINGTON — The Senate on Sunday passed a sweeping bill to make food safer, sending it to the House in the waning days of Congress.

    It was the second time the Senate passed the bill, which would give the government broad new powers to increase inspections of food processing facilities and force companies to recall tainted food. The chamber passed the bill for the first time three weeks ago, but it was caught in a constitutional snag when senators mistakenly included tax provisions that are by law supposed to originate in the House.

    The version of the legislation passed by the Senate on Sunday is amended to avoid another such mishap.

    The bill would place stricter standards on imported foods and require larger producers to follow tougher rules for keeping food safe. The legislation has enjoyed bipartisan support, and supporters say passage is crucial in the wake of E. coli and salmonella outbreaks in peanuts, eggs and produce.

    Recent domestic outbreaks of E. coli and salmonella have exposed a lack of resources and authority at the Food and Drug Administration as the embattled agency struggled to contain and trace the contaminated products. The agency rarely inspects many food facilities and farms, visiting some every decade or so and others not at all.

    The bill would emphasize prevention so the agency could try to stop outbreaks before they begin. Farmers and food processors would have to tell the FDA how they are working to keep their food safe at different stages of production.

    The House originally tried to rectify the Senate mistake by including the legislation in a year-end budget bill. Senators also included food safety in their version of the budget bill, but the spending legislation hit a roadblock when Republicans insisted it not include any add-ons.

    Senate Majority Leader Harry Reid, D-Nev., resurrected the bill – which many thought was dead as Congress rushes to wrap up for the year – by passing it and sending it to the House as a standalone measure Sunday. He said the bill is necessary because the food safety system has not been updated in almost a century.

    Sen. Tom Harkin, D-Iowa, a lead sponsor of the bill, said: "Tonight, we achieved a critical victory, bringing this bill one step closer to the finish line. I look forward to standing with the president as he signs this important measure into law."

    "It is a huge victory for consumers following a weekend cliffhanger as both consumer and industry supporters prepared for bad news," said Caroline Smith DeWaal, director of food safety at the Center for Science in the Public Interest.
  6. Michael Scally MD

    Michael Scally MD Doctor of Medicine

    House Passes Food Safety Legislation
    FDA Law Blog: House Passes Food Safety Legislation

    As expected, the U.S. House of Representatives passed the Food Safety Modernization Act (H.R. 2751) as passed by the Senate. The bill now goes to the President, who is expected to sign it into law. A copy of the bill is available here (scroll down to p. S10745). Stay tuned for more information on the bill in the near future.
  7. Michael Scally MD

    Michael Scally MD Doctor of Medicine

    A Useful Resource on the Food Safety Modernization Act
    Food Safety Modernization Act (FSMA)

    FDA has a web page devoted to the Food Safety Modernization Act (“FSMA”) that provides ready access to useful information on the new law and on FDA’s implementation activities, including: the text of the law; Q&A’s; descriptions of the work groups charged with implementation; the text of relevant speeches by the Commissioner and Deputy Commissioner for Foods; interviews with senior staff; archived webcasts of public meetings; and translations of certain materials into several languages.

    The page also provides a link to FDA’s Product Recall Page, which was revamped to be more user friendly as directed by the FSMA. Recalls, Market Withdrawals, & Safety Alerts