Showing posts with label fda. Show all posts
Showing posts with label fda. Show all posts

Friday, August 13, 2010

FRC: FDA Approves New Abortion Drug, but Deceivingly Labels Ella as 'Emergency Contraceptive'

/PRNewswire/ -- Today the Food and Drug Administration (FDA) approved Ella, a drug that can cause abortions but is misleadingly labeled as a more effective "Emergency Contraceptive."

Jeanne Monahan, Director of the Center for Human Dignity at the Family Research Council, had the following to say:

"The FDA opted against including the critical fact that Ella can cause an abortion on a baby already implanted in its mother's womb in the drug labeling information. This decision flies in the face of the Obama Administration's promise to transparency and a commitment to science. The difference between preventing and destroying life is enormous, and women have the right to know how this drug will act on their bodies and on their babies.

"Since Ella is chemically similar to RU-486 (which has been the cause of at least six deaths reported to the FDA in less than six years) it is likely that the serious health concerns for women will be similar. The FDA has very little knowledge about how this drug will impact women's health and for that reason alone should do more research before approval.

"In approving Ella, the FDA also ignored concerns raised in early August by ninety-one members of Congress, including fourteen Democrats. In a letter to the FDA Commissioner, these members requested that the FDA postpone approval of Ella until they could prove it did not cause abortions, among other conditions. Additionally, approval of Ella raises concerns about taxpayer funding of abortions, since currently the U.S. Government will pay for emergency contraception, but not abortion pills.

"The FDA advisory panel largely ignored important questions, including impacts on women's health and the abortifacient capacity of Ella. The FDA and the Obama Administration now follow suit. By approving this drug quietly on a Friday afternoon when most of Washington was on vacation, the Obama Administration and the FDA once again placed politics above science, women's health and informed consent.

"FRC and other pro-life leaders promise to do everything possible to educate the public about the truth of Ella."

Monday, August 31, 2009

Commonwealth Brands, Inc. Issues Legal Challenge to FDA

/PRNewswire/ -- Commonwealth Brands, Inc. has today joined with a number of other companies including the R.J.Reynolds Tobacco Company, Lorillard, Inc. and Conwood Company in filing an action in Federal Court against the U.S. Food and Drug Administration regarding the recently enacted Family Smoking Prevention and Tobacco Control Act. This action is designed to protect the plaintiffs' First Amendment right to free speech.

Commonwealth Brands believes that the legislation, as passed on 22 June 2009, imposes unprecedented and impermissible restrictions on its commercial free speech rights as guaranteed by the U S Constitution. If allowed, the Act will virtually eliminate the few remaining avenues that the Company has to communicate with its adult consumers.

Commonwealth Brands also believes that the Act directly violates its Constitutional rights by suppressing its lawful ability to participate in the scientific and political debate surrounding its products and unduly restricts its right to engage in commercial speech.

Jonathan Cox, CEO and President of Commonwealth Brands, Inc. said:

"Commonwealth Brands supports the Act's aim of preventing youth access to tobacco products and actively participates in youth access prevention initiatives.

"However, the Act fails to respect the legitimacy of our commercial freedoms and our right to communicate with our adult smokers. We believe that many of the provisions within the Act violate our constitutional rights and are not reasonably related to the goal of reducing youth access to tobacco products.

"This action seeks to protect our legitimate business interests and ensure that we can continue to participate in dialogue about our products and contribute to the development of reasonable and proportionate regulation."

Beyond these key Constitutional infringements, Commonwealth Brands, Inc. looks forward to partnering with the FDA to develop an effective regulatory framework for tobacco products.

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Wednesday, April 29, 2009

New Federal Legislation Targets Toxic Chemicals in Baby Bath Products

/PRNewswire / -- Today, Senator Kirsten Gillibrand (D-N.Y.) took action to protect children's health by introducing the Safe Baby Products Act, which directs the Federal Drug Administration to investigate and regulate hazardous contaminants in personal care products marketed to or used by children.

Gillibrand introduced the bill in response to a study by the Campaign for Safe Cosmetics, which revealed that many widely used baby shampoos and bubble baths are contaminated with the cancer-causing chemicals formaldehyde and 1,4-dioxane. The chemicals are not listed on labels because contaminants are exempt from labeling laws.

The Safe Baby Products Act directs FDA to test a wide range of children's personal care products, publicly report the findings, and establish good manufacturing practices to reduce or eliminate hazardous contaminants from products.

"We applaud Senator Gillibrand for being a champion for children's health," said Lisa Archer, national coordinator of the Campaign for Safe Cosmetics. "This bill is a good step forward, because it would give parents the right to know what's in the bath products they use on their kids, and would give FDA authority to keep dangerous chemicals out of children's bath products. Next, we need to overhaul cosmetics laws so the FDA can fully assess and assure the safety of all personal care products."

Gillibrand announced the Safe Baby Products Act at a press conference in New York on Monday, along with parents, medical professionals and advocacy groups. The Senator decided to take action after reading the Campaign for Safe Cosmetics' report "No More Toxic Tub" (www.SafeCosmetics.org/toxictub).

"Like many other mothers, when I read the list of these products, I immediately began to worry that I had been using some of these same products for my own children," said Sen. Gillibrand. "This common sense legislation will ensure that we have all the facts about the baby soap and lotions that we use on our children."

There are no safety standards for formaldehyde and 1,4-dioxane in personal care products sold in the United States.

The European Union has banned 1,4-dioxane from personal care products and has recalled products containing it. Formaldehyde is banned from personal care products in Japan and Sweden, and restricted in the EU and Canada.