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By Peter Reichertz, Seth Mailhot, and Robert Uram

The FDA Food Safety Modernization Act (FSMA), which was signed into law by President Obama on January 4, 2011, proposes the most sweeping reform of U.S. food safety laws in more than 70 years. As part of the changes introduced by the law, Section 103 of FSMA, titled “Hazard Analysis and Risk-Based Preventive Controls,” and Section 105 of FSMA, titled “Standards for Produce Safety,” each amend the Federal Food, Drug and Cosmetic Act by adding new sections 418 (Hazard Analysis and Risk-Based Preventive Controls )and 419 (Standards for Produce Safety ). Section 418 and 419 significantly change the existing legal requirements for food manufacturing and growing. Each section also requires the U.S. Food and Drug Administration (“FDA”) to conduct rulemaking to implement these provisions.Continue Reading FDA Issues Two Proposed Rules That Will Significantly Change Regulatory Requirements For Food Safety

By Seth A. Mailhot and Peter S. Reichertz

On December 31, 2012, the U.S. Food and Drug Administration (FDA) issued two new guidance documents on the minimum threshold of acceptability for medical device premarket submissions, which are titled “Refuse to Accept Policy for 510(k)s,” and “Acceptance and Filing Reviews for Premarket Approval Applications (PMAs).” These guidance documents detail the conditions under which a Premarket Notification [510(k)], or a Premarket Approval application [PMA] will be accepted for substantive review.Continue Reading FDA Issues Final Guidance on Filing PMAs and 510(k)s

FDA has taken no significant regulatory action with regards to claims made for cosmetics for almost twenty five years. As a result, claims for cosmetics have become aggressive, as new science and ingredients have blurred the line between cosmetics and pharmaceuticals, leading to a class of products generally referred to as “cosmeceuticals”. There is, however, no regulatory definition of a cosmeceutical, and recent regulatory actions by the FDA suggests that they believe claims for such products are drug claims.Continue Reading FDA Takes Action Against Marketers Making “Cosmeceutical” Claims

Proposition 37, the California Right to Know Genetically Engineered Food Act ("Prop 37”), if approved by the voters on November 6, 2012, will provide that food offered for retail sale in California produced with genetic engineering (“GMO food”) is misbranded unless clearly labeled to say it is genetically engineered. Prop 37 also provides that GMO “processed food” may not on its label, store signage, advertising or promotional materials state or imply that the food is “natural” or words of similar import.

Ballot materials prepared by the Legislative Analyst’s Office (LAO) state that Prop 37 could be interpreted to mean “processed food” is subject to the prohibition against “natural” labels, even if it is not produced with genetic engineering. In our view, this is not the correct interpretation of Prop. 37.Continue Reading Proposition 37 Permits “Natural” Labeling for Non-GMO Processed Food

On August 13, 2012, the Federal Trade Commission (“FTC”) proposed amendments to the Premerger Notification Rules issued under the Hart Scott Rodino Antitrust Improvements Act of 1976 (the “HSR Act”). The proposed amendments would expand when a transfer of exclusive rights to a patent in the pharmaceutical industry is potentially reportable under the HSR Act.Continue Reading FTC Proposes Amendments to the Premerger Notification Rules to Expand the Reportability of Transfers of Exclusive Patent Rights in the Pharmaceutical Industry

By Seth A. Mailhot

As part of Sheppard Mullin’s monthly blog on tobacco retailer issues, we are taking a look at the possible future of retailer-operated rolling machines. On March 8, 2012, the U.S. Senate adopted an amendment to the federal highway bill “Moving Ahead for Progress in the 21st Century Act” (MAP–21) that included a provision impacting retail establishments that offer rolling machines for use to customers. The provision would have changed the definition of “manufacturer of tobacco products” in section 5702(d) of the Internal Revenue Code of 1986 to “include any person who for commercial purposes makes available for consumer use . . . a machine capable of making cigarettes, cigars, or other tobacco products.”[1]Continue Reading Congress Contemplates Action on Rolling Machines

By Mike Emmick

In the fervor of the U.S.’s current anti-foreign-corruption efforts, a particularly misguided proposal has occasionally reared its ugly head: Requiring “mandatory debarment” for any company that violates the Foreign Corrupt Practices Act (“FCPA”).

On the merits, such a proposal is completely wrong-headed. Debarment is a severe, forward-looking administrative remedy – the corporate “death penalty” – not a vehicle to “boost” the penalties for past criminal FCPA violations.Continue Reading Mandatory Debarment for FCPA Violations? A Bad Idea Whose Time Should Never Come

By Mike Emmick and Joseph Barton

Corporate executives in the health care and environmental industries are rapidly coming to appreciate the implications of the responsible corporate officer doctrine, a recently-revitalized weapon in U.S. Department of Justice’s battle against corporate crime.

This doctrine is a peculiar exception to the usual requirements for a criminal prosecution. Ordinarily, criminal law requires a defendant to have committed a criminal act, and to have done so with criminal intent.Continue Reading The Uncomfortable Resurgence of the Responsible Corporate Officer Doctrine

By Robert Uram

On March 27, 2012, the comment period will close on a petition filed by the Center for Food Safety that calls for the FDA to issue new regulations requiring labeling of all foods produced using genetic engineering (GE). Docket No. FDA-2011-P-0723 (Filed October 12, 2011). Unlike many other developed countries – such as 15 nations in the European Union, Japan, Australia, Brazil, Russia and even China – the U.S. has no laws requiring labeling of genetically engineered foods.Continue Reading Comment Period to Close On Petition to FDA for Mandatory Labeling of All Foods Produced Using Genetic Engineering

By Seth A. Mailhot

Welcome to the next monthly installment in FDA’s enforcement of regulated tobacco products. This month we will examine some of the differences found between different states in FDA enforcement actions against retailers.

Sheppard Mullin has been closely monitoring FDA’s tobacco enforcement actions to better serve its clients. From the beginning of FDA’s program inspecting tobacco retailers, a trend emerged suggesting that there are significant differences in enforcement between retailers depending on the state in which the inspection was conducted. This raises concerns about not only in how each state conducts its retail inspection program, but the level of oversight applied by the Center for Tobacco Control over the program as a whole.Continue Reading State-by-State Differences in Retailer Enforcement