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HTMLMedical Food Mumbo Jumbo: Confusing FDA Guidance Documents Will Discourage Medical Food Development
Paul M. Hyman, A. Wes Siegner; Hyman, Phelps & McNamara, P.C.;
Legal Alert/Article
September 20, 2013, previously published on September 18, 2013
The term “medical food” was first defined by statute in the Orphan Drug Act Amendments of 1988. The medical food category is closely related to the already existing category of “foods for special dietary use,” authorized by the Federal Food, Drug, and Cosmetic Act (FDC Act),...

 

HTMLThe Reasonable Consumer’s Understanding of “All Natural” - Legal or Factual Issue?
Michelle Gillette; Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.;
Legal Alert/Article
September 14, 2013, previously published on September 12, 2013
Would “reasonable consumers” have regarded Paul Cezanne as highly had he painted numerous versions of still life with froot?

 

Adobe PDFHow to Respond When FDA Knocks: What Happens When You Say No?
Kelley Connolly Barnaby, Cathy L. Burgess; Alston & Bird LLP;
Legal Alert/Article
September 12, 2013, previously published on September 11, 2013
Two months ago, the Food and Drug Administration (FDA) issued a Draft Guidance entitled “Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug Inspection” (“Draft Guidance”). Congress required FDA to issue this guidance within a year of the enactment...

 

HTMLAre Foods that Contain GMOs “All Natural”? Some Courts Won’t Wait for FDA’s View
Ricardo Carvajal; Hyman, Phelps & McNamara, P.C.;
Legal Alert/Article
September 5, 2013, previously published on September 3, 2013
In a number of recent class actions, a central allegation has been that a marketer misled consumers by labeling as “all natural” a food that contains a genetically modified organism ("GMO"). Defendants usually invoke the doctrine of primary jurisdiction in an attempt to...

 

HTMLState Actions Grounded in “Source” Claims: Preempted or Not?
Ricardo Carvajal; Hyman, Phelps & McNamara, P.C.;
Legal Alert/Article
September 3, 2013, previously published on August 30, 2013
Is the word “source” (just “source” - not “good source” or “excellent source”) a nutrient content claim? FDA seems to think so, as reflected in a paragraph in this warning letter that escaped our attention when it issued in March 2011. FDA stated:

 

HTMLAllegation of Folded Up Mat Insufficient to Defeat Summary Judgment in Virginia Slip and Fall Case
Gregory Emrick; Semmes Bowen Semmes A Professional Corporation;
Legal Alert/Article
August 29, 2013, previously published on August 2013
Defendants Food Lion, LLC and Delhaize American, LLC (jointly, “Defendants”) filed a motion for summary judgment in a slip and fall case on the basis that Plaintiff had no admissible evidence to support the allegation of an unsafe condition.

 

HTMLFDA Serves Up Another Helping of Draft Guidance on Medical Foods
Venable LLP;
Legal Alert/Article
August 29, 2013, previously published on August 2013
On August 13th, the Food and Drug Administration (FDA) released a second version of its draft guidance on medical foods. The draft guidance, “Frequently Asked Questions About Medical Foods; Second Edition,” amends and expands upon the original draft guidance published in 2007 by...

 

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 26, 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. Consistent with that statutory...

 

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...

 


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