New FDA guidelines for foods and feeds
A study by scientists in New Zealand say craving something sweet like a biscuit or piece of chocolate could be a response to an addiction. According to Dr. Simon Thornley from Auckland’s Regional Public Health Service the reason unhealthy sugar and fat laden foods are being consumed is because they are addictive and could be
Full Post: Food-addiction blamed for obesity
The U.S. Food and Drug Administration has issued three guidances designed to help ensure the safety of FDA-regulated products in the supply chain.
The documents issued today include the following:
- Final Guidance for Industry on Voluntary Third-Party Certification Programs for Foods and Feeds;
- Draft Guidance for Industry on Submission of Laboratory Packages by Accredited Laboratories; and
- Draft Guidance for Industry on Standards for Securing the Drug Supply Chain - Standardized Numerical Identification for Prescription Drug Packages.
“The guidance documents reflect the FDA’s continued vigorous efforts to minimize the chances of unsafe products reaching American consumers,” said Jeffrey Shuren, M.D., J.D., associate commissioner for policy and planning.
The Final Guidance for Industry on Voluntary Third-Party Certification Programs for Foods and Feeds discusses the attributes of a third-party certification program that would merit the FDA’s confidence in the quality of the program’s audit. The guidance, finalizing a draft published on July 10, 2008, is intended as one of the steps in the FDA’s future recognition of voluntary third-party certification programs for foods and animal feeds. The document makes clear that it applies to any third-party certification body, including a private entity or a non-FDA federal, state, local or foreign regulatory body. Third-party certification programs can augment the ability of the FDA and the importing community to verify product safety.
The Draft Guidance for Industry on Submission of Laboratory Packages by Accredited Laboratories is intended to enhance the quality and reliability of test results submitted by importers to demonstrate that their products meet the FDA’s requirements. The guidance advises importers how to use accredited — rather than non-accredited — laboratories and makes recommendations about the quality and type of test data and information that these laboratories should produce in support of test results submitted to the FDA. The draft guidance is also intended to reduce the likelihood that an importer will select only favorable test results to submit to the FDA.
The Draft Guidance for Industry on Standards for Securing the Drug Supply Chain - Standardized Numerical Identification for Prescription Drug Packages is the first of several guidances and regulations that the FDA may issue to implement Section 913 of the Food and Drug Administration Amendments Act of 2007. This guidance recommends the standards that industry should use for the identification of individual packages containing prescription drugs. These standards will facilitate the adoption of a uniform electronic track and trace system for prescription drugs to further improve their safety and security. Both draft guidances have a 90-day comment period.
All three guidances support the FDA’s import strategy emphasizing prevention of harm, intervention when risks are identified, and rapid response after harm has occurred.
The FDA’s guidance documents do not establish legally enforceable responsibilities. Instead, guidances describe the agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited.
To view the displayed federal register notices:
- Final Guidance for Industry on Voluntary Third-Party Certification Programs for Foods and Feeds: http://www.fda.gov/oc/guidance/thirdpartycert.html
- Draft Guidance for Industry on Submission of Laboratory Packages by Accredited Laboratories: http://www.fda.gov/oc/guidance/labpackages.html
- Draft Guidance for Industry on Standards for Securing the Drug Supply Chain - Standardized Numerical Identification for Prescription Drug Packages: http://www.fda.gov/oc/guidance/drugsupplychain.html
LegitScript, an online pharmacy certification program, announced today that it has succeeded in getting nearly 500 “rogue” Internet pharmacy websites shut down. The sites had been selling prescription drugs or steroids without requiring a prescription, a practice that is illegal and considered unsafe by medical authorities. In most cases, the drugs were sold from outside
Full Post: LegitScript shuts down 500 no-prescription-required online pharmacies
The U.S. Food and Drug Administration has issued a final guidance for industry on the regulation of genetically engineered (GE) animals under the new animal drug provisions of the Federal Food, Drug and Cosmetic Act (FFDCA). The guidance, titled “The Regulation of Genetically Engineered Animals Containing Heritable rDNA Constructs,” clarifies the FDA’s statutory and regulatory authority,
Full Post: FDA issues final guidance on genetically engineered animal regulation
The U.S. Food and Drug Administration today announced the launch of a voluntary pilot program that would help promote the safety of drugs and active drug ingredients produced outside the United States. The FDA plans to select 100 applicants to participate in the Secure Supply Chain pilot program. To qualify, applicants will need to
Full Post: FDA launches pilot program to improve drug safety and active drug ingredients produced outside U.S.
A low kilojoule diet made up of higher protein meals improves the ability to burn fat among overweight and obese people and may be the key to shedding excess kilos, according to new Australian research. The study, in Nutrition & Dietetics published by Wiley-Blackwell, found higher protein meals may have a subtle fat-burning effect
Full Post: Higher protein meals help keep the fat away
Universal and annual voluntary testing followed by immediate antiretroviral therapy treatment (irrespective of clinical stage or CD4 count) can reduce new HIV cases by 95% within 10 years, according to new findings based on a mathematical model developed by a group of HIV specialists in WHO. The findings were published in The Lancet 1 today
Full Post: Universal voluntary testing, immediate treatment can reduce new HIV cases by 95% within 10 years