Content about United States administrative law

September 13, 2012
NRF warns of 'regulatory train wreck' with healthcare regulations

The National Retail Federation told a congressional panel Wednesday that the Departments of Health and Human Services, Labor and Treasury have used too much informal guidance and not enough formal rule-making in developing regulations to implement the new healthcare reform law, complicating retailers' and other employers' ability to plan for what will be required in 2014.

WASHINGTON — The National Retail Federation told a congressional panel Wednesday that the Departments of Health and Human Services, Labor and Treasury have used too much informal guidance and not enough formal rule-making in developing regulations to implement the new healthcare reform law, complicating retailers' and other employers' ability to plan for what will be required in 2014. NRF is concerned that the situation is the latest example of regulatory uncertainty that is hampering businesses' attempts to expand and create jobs.



May 29, 2012
Senate votes down Durbin supplement regulation by almost 4 to 1

Dietary supplement industry champion Sen. Orrin Hatch, R-Utah, last week led efforts to strike down an amendment that would have dramatically overregulated the dietary supplement industry.

WASHINGTON — Dietary supplement industry champion Sen. Orrin Hatch, R-Utah, last week led efforts to strike down an amendment that would have dramatically overregulated the dietary supplement industry.

February 21, 2012
FDA moves to address cancer drug shortages

An executive order from the Obama administration has spurred the Food and Drug Administration to address shortages of two cancer drugs and issue draft guidance for the industry to help prevent future shortages, the agency said Tuesday.

SILVER SPRING, Md. — An executive order from the Obama administration has spurred the Food and Drug Administration to address shortages of two cancer drugs and issue draft guidance for the industry to help prevent future shortages, the agency said Tuesday.

January 27, 2012
Harvard doctor calls for greater supplement regulation in NEJM

The New England Journal of Medicine on Thursday published an op-ed online that called for more rule-making to govern dietary supplements in an effort to rein in the criminal activity of illicit prescription drug manufacturers that openly disregard the laws currently in effect.

WASHINGTON — The New England Journal of Medicine on Thursday published an op-ed online that called for more rule-making to govern dietary supplements in an effort to rein in the criminal activity of illicit prescription drug manufacturers that openly disregard the laws currently in effect.

December 2, 2011
U.S. marshals seize supplements marketed as drugs

At the request of the Food and Drug Administration, U.S. marshals on Thursday seized all dietary supplements manufactured by Syntec because of false claims made about the safety and effectiveness of their supplements in treating a number of diseases.

HILLSBORO, Wis. — At the request of the Food and Drug Administration, U.S. marshals on Thursday seized all dietary supplements manufactured by Syntec because of false claims made about the safety and effectiveness of their supplements in treating a number of diseases.

November 28, 2011
FDA files permanent injunction against ATF Fitness Products

The Food and Drug Administration last week took legal action against the dietary supplement manufacturer ATF Fitness Products for substituting ingredients and products without noting the changes on the final product labels.

SILVER SPRING, Md. — The Food and Drug Administration last week took legal action against the dietary supplement manufacturer ATF Fitness Products for substituting ingredients and products without noting the changes on the final product labels.

The permanent injunction, filed on behalf of the FDA by the U.S. Department of Justice, would stop the defendants from making and distributing more than 400 products for being in violation of the Federal Food, Drug and Cosmetic Act. Brands include Sci-Fit, Nature's Science and For Store Only.

July 25, 2011
Industry reaction mixed to NDI draft guidance


The Food and Drug Administration last month published long-awaited draft guidance on new dietary ingredients in the Federal Register.


The Food and Drug Administration last month published long-awaited draft guidance on new dietary ingredients in the Federal Register. Once finalized, the guidance will establish an additional pillar of credibility to the dietary supplement industry and help counter criticism that the FDA does not regulate the safety of supplement products — that is, if the FDA doesn’t force supplements off the shelf that are already on the shelf today. 


May 5, 2011
FDA issues first new rules of Food Safety Modernization Act

The Food and Drug Administration has unveiled two regulations, part of the newly enacted Food Safety Modernization Act, that will take effect in July.

SILVER SPRING, Md. — The Food and Drug Administration has unveiled two regulations, part of the newly enacted Food Safety Modernization Act, that will take effect in July.

December 22, 2010
Industry praises passage of Food Safety Modernization Act by House

The House of Representatives on Wednesday passed the Food Safety Modernization Act by a vote of 215-144 to wide industry aplomb.

WASHINGTON — The House of Representatives on Wednesday passed the Food Safety Modernization Act by a vote of 215-144 to wide industry aplomb.

The bill now only needs President Barack Obama’s signature to become law.

If signed into law, the food safety bill will require biennial registration of all food manufacturing facilities, will provide the Food and Drug Administration with new authority to mandate food recalls and will require companies to develop food safety plans.

December 15, 2010
New alliance will crack down on adulterated products touting dietary supplement claims

The dietary supplement industry’s leading trade associations on Wednesday joined forces with the Food and Drug Administration to support heightened efforts to address public health problems posed by products that are illegally marketed as dietary supplements but contain the same active ingredients as FDA-approved drugs or other ingredients that do not qualify as dietary ingredients.

WASHINGTON — The dietary supplement industry’s leading trade associations on Wednesday joined forces with the Food and Drug Administration to support heightened efforts to address public health problems posed by products that are illegally marketed as dietary supplements but contain the same active ingredients as FDA-approved drugs or other ingredients that do not qualify as dietary ingredients.

December 13, 2010
FDA issues warning over Man Up Now capsules

The Food and Drug Administration on Friday warned consumers not to use Man Up Now capsules, which are marketed as a dietary supplement for sexual enhancement, because they contain a variation of an active drug ingredient found in Viagra that can dangerously lower blood pressure.

SILVER SPRING, Md. — The Food and Drug Administration on Friday warned consumers not to use Man Up Now capsules, which are marketed as a dietary supplement for sexual enhancement, because they contain a variation of an active drug ingredient found in Viagra that can dangerously lower blood pressure.

November 30, 2010
Relationship between industry, FDA is strained, PwC report finds

Recent public perception that the Food and Drug Administration had not been doing its job — ensuring that Americans' approved medical devices and medicines are relatively safe — may be impeding fast approval processes, according to a new PricewaterhouseCoopers report published Tuesday.

NEW YORK — Recent public perception that the Food and Drug Administration had not been doing its job — ensuring that Americans' approved medical devices and medicines are relatively safe — may be impeding fast approval processes, according to a new PricewaterhouseCoopers report published Tuesday.

The report, “Improving America’s Health V,” determined that the FDA’s renewed vigor for enforcing regulations may be straining the working relationship between regulator and the industry being regulated.

November 30, 2010
Senate passes bill giving FDA new powers in food regulation

The Senate on Tuesday afforded the Food and Drug Administration new powers in regulating food, according to published reports, with the passing of the FDA Food Safety Modernization Act by a vote of 73-25 (with two abstentions).

WASHINGTON — The Senate on Tuesday afforded the Food and Drug Administration new powers in regulating food, according to published reports, with the passing of the FDA Food Safety Modernization Act by a vote of 73-25 (with two abstentions).

The legislation would grant the FDA new powers to recall foods and increase inspections.

October 26, 2010
FDA: Tri-Med selling unapproved, adulterated drugs

U.S. Marshals earlier this month seized articles of prescription and over-the-counter drug products from Tri-Med...

October 13, 2010
FDA targets dietary supplements maker for selling unapproved, misbranded drugs

The Food and Drug Administration on Wednesday announced that Toby McAdam and Greta Armstrong, doing...

September 12, 2010
K-V to ship first product since 2009 manufacturing problems

Starting Monday, K-V Pharmaceutical will ship its first product since it withdrew several products in...

ST. LOUIS Starting Monday, K-V Pharmaceutical will ship its first product since it withdrew several products in 2008 and 2009 due to manufacturing problems, the drug maker said.

K-V said the Food and Drug Administration had given it approval to ship its Micro-K potassium chloride product following the completion of inspections of its manufacturing plant.

August 5, 2010
CRN head weighs in on dietary supplement industry attack in USA Today op-ed

The Council for Responsible Nutrition’s president and CEO Steve Mister supplied the “opposing view” to...

McLEAN, Va. The Council for Responsible Nutrition’s president and CEO Steve Mister supplied the “opposing view” to a USA Today opinion piece published online Thursday regarding a recent Consumer Reports attack on the dietary supplement industry.

 

May 25, 2010
FDA to provide consumer health information through Drugs.com

The Food and Drug Administration is teaming up with an online drug information Web site...

November 8, 2009
FDA warns consumers on using sexual enhancement products

This kind of news is more notable for what it doesn’t mean than what it...

NEW YORK This kind of news is more notable for what it doesn’t mean than what it means. And what it doesn’t mean is good news for the dietary supplement industry, because what it doesn’t mean is the industry is “unregulated,” or even “loosely regulated,” for those of you keeping track of how often reporters on some of the major dailies get it wrong.