FDA speakers will discuss the proposed good manufacturing practices
with dietary supplement manufacturers at an industry forum prior to
SupplySide East.
A supplement company has questioned the FDA's recent proposals to
further regulate dietary supplements, suggesting that the agency
should concentrate on the pharmaceuticals industry rather than the
'relatively safe'...
Canada's Forbes Medi-Tech said yesterday it has extended a contract
to supply its cholesterol-lowering ingredient Reducol to supplement
company Pharmavite, for use in the Nature Made Cholest-Off product.
Following a new review on the safety of ephedra, the FDA has
announced a series of actions which may tighten laws on the
marketing of herb in supplements. Industry bodies have confirmed
their support for the moves, which do not yet...
AutoImmune, through its joint venture with Deseret Laboratories
International, has begun direct sales of Colloral, a product for
the nutritional support of patients with rheumatoid arthritis.
The NNFA has welcomed the FDA's confirmation last week to exclude
health food stores from mandatory registration under the food
safety provisions contained in last year's bioterrorism law.
AAC Consulting Group, the regulatory consulting subsidiary of
contract research organisation Kendle International, has signed an
agreement with two toxicologists to further expand its services to
the food and dietary supplement industries.
The health unit of speciality chemicals manufacturer Croda
Chemicals Europe is to expand lipid production in the UK, following
increased market demand for high purity, high potency lipids in
nutraceuticals and pharmaceuticals, it...
The new commissioner for the US Food and Drug Administration, Dr
Mark McClellan, this week indicated his support for reviewing
current rules on health claims on food labels.
In light of the 18th session of the Codex Committee on Fats and
Oils to be held in London, UK on 3-7 February 2003, the US
Department of Agriculture and the Food and Drug Administration said
this week that they are to sponsor a public...
The Food and Drug Administration last week re-launched the thorny
debate on the use of trans fatty acids in food processing, and the
labeling thereof, when it reopened the comment period for a
proposed rule first published in the...
American Herbal Products Association has submitted comments to the
FDA on the agency's new adverse event reporting system. In a
letter, the trade association pointed out the inconsistency of
consumer access to the FDA's...
The Council for Responsible Nutrition last week sent a letter to
Senator Durbin and other legislators recommending several actions
be taken to protect the safety and reliability of
ephedra-containing dietary supplements.
The National Nutritional Foods Association (NNFA), a US-based trade
body, is the latest industry organistion to issue a statement
following this week's Senate hearing on ephedra in Washington. The
group reacted to Senator Durbin's...
The US Food and Drug Administration announced this week that it has
issued a 'cyber letter' to the operator of an Internet website that
was selling Yellow Jackets, an herbal product, as an alternative to
illicit street drugs.
Lonza, the Swiss-based pharmaceuticals company, has said that the
US Food and Drug Administration has allowed the sale of PepZin GI,
the subject of a new dietary ingredient submission to the federal
agency.
The US Food and Drug Administration's Center for Food Safety and
Applied Nutrition has released information on its new system for
tracking adverse event reports on foods, cosmetics and dietary
supplements.
The US Food and Drug Administration calls for a criminal
investigation into Metabolife over the safety of some of the
company's ephedra-based diet products.
The US Food and Drug Administration was put under pressure this
week when a US senator attacked the department for refusing to move
on legislation on the herbal supplement ephedra. Trade bodies still
insist however that the herb can...
An agreement with Australia's Pan Pharmaceuticals will allow Forbes
Medi-Tech to produce and market its cholesterol-lowering ingredient
Reducol as a dietary supplement for the first time.
Switzerland's Lonza group has confirmed its commitment to the
construction of a major new production facility in the town of Visp
with the announcement of a SFr100 million (€68.4m) investment in a
biopharmaceuticals manufacturing...
The US authorities have announced plans for further research into
the effects of the herbal product ephedra, and a clampdown on the
illegal marketing of non-herbal synthetic ephedrine products.
The US Food and Drug Administration (FDA) has responded to a
request from the US Congress and drawn up a detailed analysis of
the likely cost of implementing the Dietary Supplement Strategy
10-Year Plan, drawn up in January 2000 to...
Amarillo Biosciences of Texas has signed two new agreements which
will see its dietary supplements enter China, Taiwan and Pakistan
for the first time.
President Bush is being put under pressure to find someone to take
on the role of head of the US Food and Drug Administration (FDA),
reports the Financial Times.
Italian pharmaceutical group Sigma-Tau has created a new US
subsidiary, Sigma-Tau US, which will group together its three
separate North American businesses for the first time.
The Council for Responisble Nutrition has become the second US
supplement association to issue voluntary warning labels about the
potential health risks of kava kava following a similar move by the
American Herbal Products Association...
Dietary supplements could interact with heart medicines and
increase the risk of adverse reactions, according to the results of
a new study from the University of Michigan. Nearly three-quarters
of heart patients surveyed in the study...
A dietary supplement which claims to be an effective weight loss
agent has been linked to severe liver damage in seven healthy
people, according to research published in the US Annals of
Internal Medicine this week.
An investigation by a coalition of dietary supplement makers into a
possible link between popular health supplement kava kava and an
increased risk of liver failure has exonerated the herb, although
the study's author urged that...
The Council for Responsible Nutrition in the US has responded
angrily to a recent survey by in the journal JAMA which claimed
that the increased use of herbal supplements could lead to adverse
reactions with other drugs.
A recent survey by the National Consumers League (NCL) in the US
shows that 75% of Americans believe that products labelled
'natural' should contain at least 90% or more natural ingredients
and that 86% of those questioned...
Nutraceutix, an early stage biopharmaceutical company, has engaged
investor relations and strategic planning company Bibicoff &
Associates to increase investment community awareness of the
company.
Following recent controversy surrounding the popular herb kava the
American Botanical Council (ABC) is suggesting that consumers
follow additional precautions when using the herb, used for
reducing symptoms of anxiety and stress.
A new bill in the US that could give tax breaks to employees who
purchase dietary supplements and medicinal foods has been referred
to the Committee on Ways and Means in the House of Representatives.
In Part One of this article Henry Miller and David Longtin look
at the overall regulation of dietary supplements across the Western
world and highlight the many shortfalls.
