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* You are viewing Posts Tagged ‘GMP’

Overheard: The Best (and Worst) From Congressional Hearing on Cosmetic Safety

admin April 05, 2012 Cosmetics, Law & Regulatory 1 Comment

Tags: authority, best, budget, CFSAN, cosmetics, Energy and Commerce, FDA, FSMA, GMP, hearing, ingredients, Michael Landa, pink slime, quotes, regulation, Rep. Schakowsky, resources, statistics, testimony, user fees, worst

Michael Landa at Cosmetics Safety Hearing

Below are some of our favorite quotes and exchanges from last week’s Energy and Commerce Subcommittee on Health hearing, “Examining the Current State of Cosmetics.”  If you haven’t read our first blog about it please read that here.  What follows below are some of the more interesting quotes and exchanges from Michael Landa’s testimony portion of the hearing (our thoughts in italics):

 “FDA’s current authority is principally post-market…the pre-market authority is limited to color additives… we have the authority to ban ingredients … READ MORE

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Cosmetics Back on the Chopping Block? FDA Wants User Fees, Cosmetic Registration in Light of Safety Fears

admin April 05, 2012 Cosmetics, Imports, Law & Regulatory 1 Comment

Tags: authority, budget, CFSAN, cosmetics, Energy and Commerce, FDA, FSMA, GMP, hearing, ingredients, Michael Landa, regulation, resources, statistics, testimony, user fees

Cosmetics on the Chopping Block

Last week the U. S. House of Representatives, Energy and Commerce Subcommittee on Health, held a hearing entitled, “Examining the Current State of Cosmetics,” the first of its kind in decades, featuring panel testimonies and inquiry related to the overall safety of cosmetics in the USA.  A few assumptions emerged as the hearing got underway:

Cosmetics are under-regulated compared to other products

The FDA has shockingly little resources assigned to cosmetics

The FDA has little authority to regulate, recall, etc…

There … READ MORE

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Recently Published FDA Import Refusal Report May Cause Complications for Foreign Manufacturers

admin March 02, 2011 Imports, Law & Regulatory 1 Comment

Tags: admission, china, CIQ, compliance, contents, declaration, facility, FDA, FDCA, federal, Food drug and Cosmetic act, foreign, GMP, good manufacturing practice, health, import refusal, inspection, labeling, manufacturer, net quantity, origin, Quarantine, regulatory, report, united states, violation

FDA recently made its Import Refusal Report available again on its website. The FDA Refusal Report lists products FDA refused admission into the United States because the product appeared to violate the Federal Food, Drug, and Cosmetic Act (FDCA), and FDA believes that the importer of record failed to present evidence sufficient to demonstrate compliance. Of course, FDA may refuse articles under the FDCA for many reasons unrelated to health or safety: for example, because the product label does not conform to all the technicalities of the FDCA. FDA says it provides the FDA Refusal Report page for the public … READ MORE

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