Category:

The Marketplace

As CBD Sales Grow, FTC Cautions Against Misrepresentations

On September 10, 2019 the Federal Trade Commission (FTC) sent warning letters to three companies that sell oils, tinctures, capsules, “gummies,” and creams containing cannabidiol (CBD) regarding the companies’ false advertising practices. Cannabis is a plant of the Cannabaceae family and contains more than eighty biologically active chemical compounds. The most commonly known compounds are delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD). CBD does not cause intoxication like THC.

The Mail’s Here!: The Unexpected Complexities of Shipping Hazardous Materials

In this day and age, virtually anything can be shipped anywhere. No matter the destination, an item arrives at our door with only a few clicks. Rarely do we stop to think about how it gets to our door. We often overlook the regulations surrounding each package on its journey. The shipping of simple, everyday items, is fairly straight-forward and regulations more relaxed. However, the shipment of complex items, like hazardous materials, carries additional challenges.

FDA Issues Warnings Regarding E-Cigarettes

On Wednesday, September 11, 2019, the Trump Administration issued a statement regarding the recent outbreak of illnesses and deaths related to the use of electronic cigarettes (“e-cigarettes”). Soon after, the Food and Drug Administration (“FDA”) quickly followed suit. The Trump Administration’s statement comes after reports of 380 cases of lung illness associated with the use of e-cigarettes in 36 states, in addition to 7 deaths. Both political parties have pressed for flavor bans, age restrictions, and other restrictions on the sale of vaping products. They have urged the FDA to move quickly and decisively to investigate and regulate e-cigarettes. E-cigarettes have been touted by manufacturers as a way to wean people from traditional cigarettes but have recently led to an “epidemic” of youth vaping of nicotine. E-cigarettes are popular among teens due to their availability, advertisements, e-liquid flavors, and the belief that they are safer than cigarettes. The long-term risks of vaping are currently unknown, but a growing numbers of studies show that e-cigarette vapor has severe health risks, including damaging lung tissue and blood vessels.

Social Media Sweepstakes: As Easy as Reposting or Liking?

Sunny Co Clothing posted a photo of a woman wearing a red swimsuit with a caption reading “EVERYONE that reposts and tags us in this picture within the next 24 HOURS will receive a FREE Pamela Sunny Suit” – along with other applicable rules. Instagram went crazy with thousands of reposts. The following day, Sunny Co Clothing posted a second photo stating that they had the right to cap the promotion if they so choose. Many people, myself included, questioned how this retraction was possible. Could it be as simple as reposting an Instagram photo and tagging the company to receive a $64.99 swimsuit for free? The answer is yes, but with a caveat.  One must follow the federal sweepstakes laws, applicable sweepstakes laws of the participants’ home states, and the governing rules of all the social medial platforms where the post appears. Easy, right?

When the American Dream Causes an American Nightmare

At first, the story of John Kapoor’s rise to the top of the pharmaceutical industry sounds like the American dream played out in real life. The first to attend college in his family, Kapoor graduated from Bombay University in India with a degree in pharmacy. He came to the United States after securing a fellowship at the University of Buffalo, and earned his Ph.D. in 1972. His scientific and business savvy was evident from the start – in a matter of a decade, Kapoor took over a struggling pharmaceuticals business, turned it around, and netted a personal gain of $100mm. From there Kapoor became a serial entrepreneur, with INSYS Therapeutics marking the pinnacle of his success. The company made him a billionaire, but later made him the target of a criminal racketeering investigation and the face of one of America’s darkest problems.

Protecting the Nanotechnology Workforce: NIOSH Regulations

The Department of Health and Human Services, along with National Institute for Occupational Health and Safety and the Center for Disease Control have begun a concerted effort to fill the knowledge gaps in defining the hazards, exposures, and risks involved with handling nanomaterials. Investigators are working to provide guidance for those working in the field of nanotechnology to address the risks associated with working with animals exposed to various engineered nanomaterials, epidemiologic research, and exposure limits.  The National Institute for Occupational Safety and Health has summarized its progress and recommended risk management strategies for those in the field.

Lessons from Theranos

Theranos, the health-tech and medical lab startup, was once one of the most hyped companies to come out of Silicon Valley. In 2014, after catching the attention of high-profile investors, the company reached a valuation of $9 billion. Following several employee and journalistic leaks in 2015, however, the public began to see the company for what it was, a fraud. An October 3, 2016 Inside Compliance article titled “Theranos: New Compliance Program Hopes to Save the Company,” was written following Theranos’ appointment of two outside executives to oversee regulatory, quality, and compliance standards. It is now clear that these efforts to save Theranos were too little too late, but we see some useful takeaways from Theranos’ downfall. This article will explore the key lessons learned as it relates to leadership, ethics, and compliance.

Proposed Changes to the Clinical Laboratory Improvement Amendments of 1988

The Department of Health and Human Services Center for Medicare and Medicaid Services have proposed a ruleto update the proficiency testing (PT) regulations under the Clinical Laboratory Improvement Amendments of 1988 (CLIA).  The new rule seeks to address current analytes, substances or constituents for which the laboratory conducts testing, and newer technologies.  The rule would further make technical changes to the PT referral regulations to be more closely aligned with the CLIA statute.

Health and Human Services Promulgates New Abortion “Gag” Rule; Opponents Prepare for Legal Challenges

On February 22, 2019, the Department of Health and Human Services submitted a final rule to the Federal Register, substantially altering existing guidelines for family planning programs’ reception of federal funds under Title X of the Public Health Service Act (PHS Act). Among other things, the new regulations prohibit qualifying programs from referring patients to abortion providers. Public statements from organizations such as Planned Parenthood suggest lawsuits for injunctive relief are imminent.

Senators Urge FDA to Update Its Regulation on Products Containing Hemp and Hemp-derived Compounds

On January 15, 2019, Senators Ron Wyden and Jeff Merkley sent a letter to the U.S. Food and Drug Administration (FDA) urging the agency to update its federal regulations governing the use of certain cannabis-derived ingredients in food, beverages and dietary supplements. As writers of the Hemp Farming Act, Wyden and Merkley, initiated the removal of the hemp plant and derivatives of Cannabis sativa from the list of controlled substances under the Controlled Substance Act. The Hemp Farming Act passed as a provision in the Agriculture Improvement Act of 2018, and thus, legalized the production and sale of industrial hemp and hemp-derived compounds, including cannabidiol (CBD).