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Adobe PDFUncommon (and Hefty) Antitrust and False Advertising Verdict
Richard J. Leighton; Keller and Heckman LLP;
Legal Alert/Article
September 27, 2013, previously published on September 23, 2013
It’s uncommon to try a technical Lanham Act false advertising case to a jury, and it’s even less common to intermingle such a case with complex antitrust claims under the Sherman and Clayton Acts. A Texas federal jury faced with that unusual combination recently delivered a whopping...

 

HTMLSubmitters of Active FCNs Will Receive Objection Letters if the Government Shuts Down, FDA's Keefe Says at Keller and Heckman Conference
Keller Heckman LLP;
Legal Alert/Article
September 27, 2013, previously published on September 25, 2013
If a government shutdown occurs at the end of FY 2013 (September 30, 2013), the Food and Drug Administration (FDA) will send formal objection letters to submitters of pending food contact notifications (FCNs), effectively denying them because the Agency would not have sufficient funds to operate...

 

Adobe PDFCalifornia Green Chemistry Regulation to Be Effective October 1, 2013
Keller Heckman LLP;
Legal Alert/Article
September 9, 2013, previously published on September 4, 2013
On August 23, 2013 the Department of Toxic Substances Control (DTSC) released the final version of the Safer Consumer Products Regulation that had been reviewed by the Office of Administrative Law for a 15 day comment period, limited to comments on the changes that were made as a result of this...

 

HTMLFDA Issues Revised Draft Guidance on "Medical Foods"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On August 13, the Food and Drug Administration (FDA) announced the availability of a draft guidance entitled “Frequently Asked Questions About Medical Foods; Second Edition.” The draft guidance updates and expands a previous draft issued in May 2007 regarding the definition, labeling,...

 

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)....

 

HTMLSenate Committee on Environment and Public Works Holds Hearing on TSCA Reform
Keller Heckman LLP;
Legal Alert/Article
August 7, 2013, previously published on August 5, 2013
On July 31, 2013, the Senate Committee on Environment and Public Works held a hearing entitled, “Strengthening Public Health Protections by Addressing Toxic Chemical Threats.” The hearing was called by Chairman Barbara Boxer (D-CA), who sought to discuss approaches to TSCA reform,...

 

HTML"Gluten-Free" Claims - FDA Publishes Final Rule
Evangelia C. Pelonis, Laura Venker; Keller and Heckman LLP;
Legal Alert/Article
August 7, 2013, previously published on August 7, 2013
The Food and Drug Administration (FDA) has published a final rule that defines the term “gluten-free” and deems misbranded any use of such a claim or related claims on foods that do not meet the definition. The final rule creates new 21 CFR 101.91 in Subpart F—Specific...

 

HTMLEPA Proposes Rules to Implement the Formaldehyde Emissions Standards for Composite Wood Products and Deviates Greatly from California's Standard
Komal K. Jain, Peter L. de la Cruz; Keller and Heckman LLP;
Legal Alert/Article
August 5, 2013, previously published on August 5, 2013
By and large, industry supported the creation of a federal formaldehyde emission standards program with the expectation that EPA would promulgate standards that mirrored California Air Resources Board (CARB) regulation 93120, Airborne Toxic Control Measure (ATCM) to Reduce Formaldehyde Emissions...

 

HTMLU.S. House of Representatives Initiates Series of Hearings to Discuss the Toxic Substances Control Act
Martha E. Marrapese; Keller and Heckman LLP;
Legal Alert/Article
August 2, 2013, previously published on July 2013
On June 13, 2013, the House Environment and the Economy Subcommittee of the Energy and Commerce Committee held a hearing entitled “Title I of the Toxic Substances Control Act: Understanding its History and Reviewing its Impact.” Given the attention the Toxic Substances Control Act...

 


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