Crack Down on Vitamins Again?

GAO report – Dietary Supplements: FDA Should Take Further Actions to
Posted by: “Douglas Kalman” dkalman@miamiresearch.com   dougkalman
Mon Mar 2, 2009 12:28 pm (PST)

New GAO Report Finds Need for Additional FDA Oversight of Dietary
Supplements

<http://energycommerce.house.gov/index2.phpoption=com_content&do_pdf=1&id=1509>

<http://energycommerce.house.gov/index2.phpoption=com_content&task=view&id=1509&pop=1&page=0&Itemid=1>

Rep. Henry A. Waxman (D-CA), Rep. John D. Dingell (D-MI), Rep. Bart
Stupak (D-MI), and Sen. Dick Durbin (D-IL) released a new Government
Accountability Office (GAO) report identifying several factors that
limit FDA’s ability to protect consumers from unsafe dietary
supplements. These factors are limits on FDA’s authority to obtain
information about dietary supplements on the market, few FDA resources
devoted to dietary supplement oversight, and limits on FDA’s authority
to remove unsafe dietary supplements from the market.

The report calls for additional FDA regulatory authority to ensure
better FDA oversight of dietary supplements, including enhanced
registration of dietary supplement facilities and expanded reporting of
adverse health effects of supplement products. The report recommends
that FDA issue guidance to industry to clarify which supplement
ingredients are new and to submit evidence of safety before they can be
marketed. The report also notes the need for more consumer outreach and
education.

“I am troubled that the FDA lacks the basic information necessary to
protect consumers from unsafe dietary supplements,” said Rep. Waxman,
Chairman of the Energy and Commerce Committee. “The FDA clearly needs to
have more resources to give consumers real protection. I intend to work
with my colleagues in Congress to ensure that FDA has the tools it needs
to address this and other important public health missions.”

“We know that there are problems with the FDA. Reports like this show us
just how deep the problems run,” said Rep. Dingell, Chairman Emeritus of
the Energy and Commerce Committee. “FDA is woefully unprepared to deal
with dietary supplements and in its current condition, FDA can not fix
the problem. FDA needs the resources and adequate authorities so the
agency can start addressing this problem. The GAO findings are quite
valuable and Americans will be quite distressed as they learn just how
ineffective the FDA has become in regulating dietary supplements.”

“Based on GAO’s analysis, we can add dietary supplements to the growing
list of products that show the FDA is failing at its core mission of
protecting the public’s health,” said Rep. Stupak, Chairman of the
Oversight and Investigations Subcommittee. “We need new leadership in
place at the FDA to finally begin the task of recommitting the agency to
protecting the American people from unsafe food, drugs, medical devices
and now dietary supplements. The FDA should review and quickly implement
GAO’s recommendations, particularly working to expand efforts to collect
adverse event data from consumers in order to better understand the
problems encountered with use of dietary supplements.”

“There are 29,000 varieties of dietary supplements on the market today
with 1,000 new products being introduced each year. Many of these
products are safe; I take my vitamins every day. The problem is that
some supplements contain concentrated extracts of herbs and botanicals
mixed with other ingredients that can be harmful,” said Assistant Senate
Majority Leader Durbin. “Our experience with ephedra should convince
everyone that the FDA should have the regulatory authority it needs to
protect the American consumer. I will continue work with my colleagues
in Congress and with the administration to make sure we do to everything
we can to protect the public health.”

The GAO report, Dietary Supplements: FDA Should Take Further Actions to
Improve Oversight and Consumer Understanding
<http://energycommerce.house.gov/Press_111/20090302/gaoreport.pdf> ,
states that a lack of information is one of the most significant factors
that limit the FDA’s ability to identify and properly act on safety
concerns regarding dietary supplements and foods with added dietary
ingredients. GAO recommends that the FDA issue guidance on new dietary
ingredients and clarify the difference between dietary supplements and
foods with added dietary ingredients to prevent firms from circumventing
safety standards by simply reclassifying their products as dietary
supplements. The report noted the need for improved education and
outreach efforts to increase consumer understanding of the safety and
efficacy of dietary supplements and foods with added dietary
ingredients. And GAO also recommends that the FDA be given additional
authority to require firms to self-identify as dietary supplement
companies, to provide information about their dietary supplement and
dietary additive products and ingredients, and to report adverse events.

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4 Responses to Crack Down on Vitamins Again?

  1. […] energizecc wrote an interesting post today onHere’s a quick excerpt GAO report – Dietary Supplements: FDA Should Take Further Actions to Posted by: “Douglas Kalman” dkalman@miamiresearch.com   dougkalman Mon Mar 2, 2009 12:28 pm (PST) New GAO Report Finds Need for Additional FDA Oversight of Dietary Supplements <http://energycommerce.house.gov/index2.phpoption=com_content&do_pdf=1&id=1509&gt; <http://energycommerce.house.gov/index2.phpoption=com_content&task=view&id=1509&pop=1&page=0&Itemid=1&gt; Rep. Henry A. Waxman (D-CA), Rep. John D. Dingell (D-MI), Rep. Bart Stupak (D-MI), and Sen. Dick Durbin (D-IL) released a new Government Accountability Office (GAO) report identifying several factors that limit FDA’s ability to protect consumers from unsafe dietary supplements. These factors are limits on FDA’s authority to obtain information about dietary supplements on the market, few FDA resources devoted to dietary supplement oversight, and limits on FDA’s authority to remove unsafe dietary supplements from the market. The report calls for additional FDA regulatory authority to ensure better FDA oversight of dietary supplements, including enhanced registration of dietary supplement facilities and expanded reporting of adverse health effects of supplement products. The report recommends that FDA issue guidance to industry to clarify which supplement ingredients are new and to submit evidence of […] […]

  2. 234 says:

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  3. […] Dan Gilliland’s Secret Key to Health put an intriguing blog post on Crack Down on Vitamins Again?Here’s a quick excerptGAO report – Dietary Supplements: FDA Should Take Further Actions to Posted by: “Douglas Kalman” dkalman@miamiresearch.com    dougkalman Mon Mar 2, 2009 12:28 pm (PST) New GAO Report Finds Need for Additional FDA Oversight of Dietary Supplements http://energycommerce.house.gov/index2.phpoption=com_contentdo_pdf=1id=1509 http://energycommerce.house.gov/index2.phpoption=com_contenttask=viewid=1509pop=1page=0Itemid=1 Rep. Henry A. Waxman (D-CA) […]

  4. 82 says:

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