Category Archives: Drug & Cosmetic Law

Trump Administration Limits Affordable Care Act’s Contraceptive Coverage Mandate

On Friday October 6, 2017, the Trump administration released two interim final rules expanding the exemptions allowed under the Patient Protection and Affordable Care Act’s (the “ACA’s”) contraceptive coverage mandate. Under the ACA, employer group health plans generally are required to cover contraceptives, sterilization, and related patient education and counseling, with exemptions provided for religious …

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Cannabis Prop 65 Liability: Lessons Learned from the Dietary Supplement Industry

The cannabis industry appears to be next on the liability “hit list” under California’s notorious Proposition 65 statute. In June 2017, more than 700 Prop 65 notices were served on California cannabis businesses. Companies in this emerging market should start mitigating risk under Prop 65 now. Fortunately, lessons can be learned from the dietary supplement …

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Pharmaceutical Issues

Worried About Fake News? You Should Really Worry About Fake Drugs

While the concept of “fake news” continues to trigger Twitter followers and grab headlines, the trade in counterfeit drugs is a worldwide problem of significant scale.  This article discusses the problem and talks about some things trademark owners are doing to address the public safety issues posed by fake drugs. The Problem. Trademark counterfeiting?  Most …

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marijana Medical Marijuana Laws

Growing Questions About Employee Medical Marijuana Use Leave Employers in a Haze

The intersection of employment and marijuana laws has just gotten cloudier, thanks to a recent decision by the Rhode Island Superior Court interpreting that state’s medical marijuana and discrimination laws. In Callaghan v. Darlington Fabrics Corporation, the court broke with the majority of courts in other states in holding that an employer’s enforcement of its neutral …

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Pharmaceutical Issues

New FDA Commissioner Hits the Ground Running

Fresh off his noticeably smooth confirmation, the new Commissioner of Food and Drugs, Dr. Scott Gottlieb, appeared before Congress last Thursday and unveiled his strategic initiatives and priorities for the Trump Food and Drug Administration (“FDA”).  These run the gamut from improving regulatory science and policies to streamlining clinical trials to spurring innovation on behalf of patients.  …

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Voluntary Product Registry: Dietary Supplement Update

Leading dietary supplement trade association makes strides in developing product registry. As previously covered, a leading dietary supplement trade association — the Council for Responsible Nutrition (CRN) — has been pursuing the goal of creating a Voluntary Product Registry for Dietary Supplements.  According to CRN, the goal of the registry is to increase transparency and give …

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New Board of Pharmacy Regulations Significantly Narrow the Sole Proprietor Exemption and Impose New Compounding Standards

New regulations from the Ohio State Board of Pharmacy now require any prescriber who will possess, have custody or control of, or distribute dangerous drugs that are compounded or used for the purpose of compounding to be licensed as a Terminal Distributor of Dangerous Drugs (TDDD). This new requirement is particularly noteworthy for physicians, dentists, …

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Pharmaceutical Issues

The UK Psychoactive Substances Act 2016: An Example of Poor Drafting and Unintended Consequences for Food?

The UK has enacted new legislation to address the issue of so-called ‘legal highs’ following a number of cases of paranoia, seizures, hospitalisation and even death after consumption of certain psychoactive substances.  The Psychoactive Substances Act 2016 (the “Act”) was granted Royal Assent on 28 January 2016.  It is expected to come into force on …

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marijana Medical Marijuana Laws

Marijuana in the Workplace: The Growing Conflict Between Drug and Employment Laws

Despite the growing number of states that have legalized the use of marijuana, the drug remains illegal under federal drug laws. The legal landscape is made more confusing when considering the differing levels of employment protection that these state laws offer to marijuana users. With this patchwork of state laws, employers are left to grapple …

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Marijuana-Legalization Efforts and Their Impact on the Presidential Race

With the race for the White House heating up, the “politics of marijuana” is looming as a possibly significant factor. Twenty-four state ballot initiatives on marijuana legalization in 16 states have been filed already and will be voted on in November 2016, including in the “swing states” of Arizona, Colorado, Florida, Michigan, Missouri, Nevada, and …

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