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HTMLFSMA and Third-Party Audits: What is a “Serious Risk to the Public Health?”
Ricardo Carvajal; Hyman, Phelps & McNamara, P.C.;
Legal Alert/Article
August 23, 2013, previously published on August 21, 2013
In poring over FDA’s recently issued proposed rule on Accreditation of Third Party Auditors, one thing that caught our eye is FDA’s discussion of FSMA’s notification requirement for auditors. That requirement is embedded in new § 808(c)(4) of the FDC Act.

 

HTMLChina Hands Milk Producers the Largest Anti-Monopoly Violation Fine
Sam Davis, Michael X.Y. Zhang; Sheppard, Mullin, Richter & Hampton LLP;
Legal Alert/Article
August 22, 2013, previously published on August 19, 2013
On August 7, 2013, the National Development and Reform Commission (“NDRC”) fined six powdered milk companies - five foreign and one Hong Kong-based - RMB668 million (approximately US$109 million) for engaging in anti-competitive practices and illegal price-fixing, the largest fine ever...

 

HTMLFDA Issues Revised Draft Guidance on "Medical Foods"
Melvin S. Drozen, Frederick A. Stearns, Laura Venker; Keller and Heckman LLP;
Legal Alert/Article
August 19, 2013, previously published on August 15, 2013
On August 13, the Food and Drug Administration (FDA) announced the availability of a draft guidance entitled “Frequently Asked Questions About Medical Foods; Second Edition.” The draft guidance updates and expands a previous draft issued in May 2007 regarding the definition, labeling,...

 

HTMLNew Dietary Ingredients Revisited - Let’s Not Forget There’s a Law
A. Wes Siegner; Hyman, Phelps & McNamara, P.C.;
Legal Alert/Article
August 19, 2013, previously published on August 15, 2013
In response to a history of FDA illegal restriction of the marketing of dietary supplements in the 1980s and early 1990s, Congress amended the Federal Food, Drug, and Cosmetic Act (“FDC Act”), passing by unanimous consent the Dietary Supplement Health and Education Act of 1994...

 

HTMLNew FDA Draft Guidance for Medical Foods Suggests that Some Common Products and Certain Label Statements Violate FDA Regulations
Etan J. Yeshua; Hyman, Phelps & McNamara, P.C.;
Legal Alert/Article
August 17, 2013, previously published on August 14, 2013
Earlier this week, FDA provided new insight into its interpretation of the definition and regulation of medical foods — a legal category established by the Orphan Drug Act of 1988, incorporated into the Federal Food, Drug, and Cosmetic Act in 1990, and seemingly narrowed in scope by...

 

HTMLMagistrate Judge Recommends Certification of Two Proposed Classes in “vitaminwater” Litigation
Mark D. Campbell, Livia M. Kiser, Michael L. Mallow; Loeb & Loeb LLP;
Legal Alert/Article
August 16, 2013, previously published on August 2013
A federal magistrate judge in New York has recommended that New York and California classes be certified to pursue injunctive and declaratory relief against Coca-Cola and Energy Brands for allegedly deceptive labeling of its “vitaminwater” brand of beverages based on, among other...

 

HTMLFood for Thought: Understanding FDA's Proposed Rules for Importers of Food and Dietary Supplements and How They May Impact Your Business
Venable LLP;
Legal Alert/Article
August 15, 2013, previously published on August 13, 2013
With approximately 15% of all food consumed in the United States coming from overseas, the U.S. Food and Drug Administration (FDA) has renewed its focus on imported food safety and now seeks to place risk-based preventive controls squarely on the importing community. On July 29, 2013, FDA...

 

HTMLFDA Sued for Failure to Ban Partially Hydrogenated Oils
Ricardo Carvajal; Hyman, Phelps & McNamara, P.C.;
Legal Alert/Article
August 14, 2013, previously published on August 13, 2013
Fred Kummerow, a Professor Emeritus at University of Illinois, sued FDA for failing to respond to his citizen petition (Docket No. FDA-2009-P-0382) asking the agency to ban partially hydrogenated oils containing artificial trans fat. The citizen petition was submitted in August 2009, and the...

 

Adobe PDFOverview of FDA's Proposed Rule to Implement FSMA's Foreign Supplier Verification Programs for Importers of Food for Humans and Animals
Deborah C. Attwood, Melvin S. Drozen, Evangelia C. Pelonis; Keller and Heckman LLP;
Legal Alert/Article
August 9, 2013, previously published on August 1, 2013
On July 29, 2013, FDA published its long-awaited proposed rule to implement the Foreign Supplier Verification Program (FSVP) of the FDA Food Safety Modernization Act (FSMA). This proposed rule establishes the verification activities that importers of food must undertake to ensure that the food they...

 

Adobe PDFOverview of FDA's Proposed Rule to Implement FSMA's Accreditation of Third-Party Auditors/Certification Bodies to Conduct Food Safety Audits and to Issue Certifications
Deborah C. Attwood, Melvin S. Drozen, Evangelia C. Pelonis; Keller and Heckman LLP;
Legal Alert/Article
August 9, 2013, previously published on August 1, 2013
On July 29, 2013, the Food and Drug Administration (FDA) published a proposed rule regarding the accreditation of third-parties. The proposed rule implements Section 307 of the Food Safety Modernization Act (FSMA), which added Section 808 to the Federal Food, Drug, and Cosmetic Act (FD&C Act)....

 


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