Tag:

Regulation

The Food Safety Modernization Act is Just the Beginning of the FDA Compliance We’ve Been Waiting For

Despite the United States having one of the safest food supplies in the world, more than 48 million Americans get sick from foodborne illnesses and diseases each year, and more than 128,000 are hospitalized and 3,000 die from similar issues that are largely preventable. On January 04, 2011 President Obama signed the Food Safety Modernization Act (“FSMA”) into law. This enactment was called the “most sweeping reform” of U.S. Food Safety laws in more than seventy years. But seven years later, the act is still only partially enforced as the FDA has faced resistance from the government as well as a lack of funding. The FMSA was and is intended to enable the FDA to protect the health of the public by strengthening the food system in the United States. While change and reform in the industry are necessary, what good are new reforms if they will not be enforced for years to come?

Popularity Contest: The Importance of Reputation in Modern Compliance

Modern business thinking has come to accept that reputation is as important as financials. As investors look for companies that demonstrate this understanding, compliance professionals are in a unique position to make their companies more appealing.

Trump Administration Deregulates Housing

As President Donald Trump continues to deliver on his promise to deregulate, the Department of Housing and Urban Development (HUD) has been instrumental in reversing Obama-era regulations.  President Trump, who made his fortune in real estate development, has a checkered past when it comes to fair housing and discrimination.  Now his administration is working to cut funding to HUD and unwind many fair housing and discrimination rules.  Administration proponents say this is a necessary step to fix a broken and corrupt bureaucracy, while many advocates have expressed concern over the government scaling back enforcement of fair housing laws.  Any reform effort should seek to balance concerns about bureaucracy with the vital missions of fair discrimination-free housing, inclusive communities, and civil rights.  

Deregulation of Uranium Mining or: How I Learned to Stop Regulating and Love the Bomb

Compliance professionals all over the country are paying close attention to the Trump administration’s deregulatory campaign. While deregulation in finance has received the most media attention, the uranium mining industry has been a quiet beneficiary of the President’s new regulatory scheme.

How will the Supreme Court’s new rule barring the government from refusing offensive trademarks affect the marketplace?

On June 19, 2017, the Supreme Court, in an 8-0 ruling, found that the government can no longer sensor trademarks on the grounds that they may be offensive. In Matal v. Tam, the Supreme Court Justices found the seventy-one year old rule allowing the government to refuse offensive trademarks to be unconstitutional and to violate free speech and first amendment rights. The justices were unable to agree on exactly what legal standard was to apply to the present case or future cases. The revocation of this seventy-one year old rule that has affected the registration of many marks over the years is bound to have an effect on the future of trademark law and trademark litigation. Immediately following the Supreme Court’s decision, the United States Patent and Trademark Office (USPTO) was inundated with requests to register offensive trademarks.

Trump Administration Deregulates Financial Services

The Trump administration is delivering on its promise to deregulate America.  Since taking office, numerous regulations spanning everything from energy to health care have been repealed or weakened.  The financial services industry is not immune to the deregulation movement.  The Trump administration is acting through appointments, executive agencies, and legislation to deregulate the financial services industry.  Proponents of deregulation claim the movement is needed after Dodd-Frank and strict post-financial crisis regulation.  However, in deregulating financial services, the Trump Administration—and compliance professionals—should proceed cautiously. 

What Does a Federal Government Shutdown Mean for Compliance?

For the first time since 2013, on Saturday, January 20th, 2018, the U.S. government ran out of money when Congress failed to pass a spending bill to fund the federal government. Much of the federal government’s operations have ground to a halt due to the lack of funding. Because Congress is seemingly at an impasse over immigration policy, the shutdown may last several days, if not weeks. In light of Loyola’s upcoming symposium exploring what happens when regulation is not enforced, it is interesting to consider how, in a similar vein, the shutdown affects compliance.

Cannabusiness – Banking in California

In November of 2016 voters in California passed the Adult Use of Marijuana Act which legalized the sale and use of marijuana throughout the state, similarly to states such as Colorado and Washington. Starting January 1, 2018, it will be legal to go to a licensed dispensary and purchase marijuana for personal use, without needing a medical marijuana card. However, marijuana possession or use is still a federal offense; navigating the new law can be hazy.

As Hollywood is Flooded with Sexual Misconduct Allegations, Special Task Force of Prosecutors Could Save the Day

In the midst of countless sexual misconduct allegations against some of Hollywood’s most powerful people, on November 9, 2017, Los Angeles District Attorney, Jackie Lacey, issued a statement outlining a plan of action. A special task force of veteran sex crimes prosecutors has been assembled to ensure a “uniformed approach to the legal review and possible prosecution of any case that meets both the legal and factual standards for criminal prosecution.” The Beverly Hills and Los Angeles Police Departments are conducting investigations of the accused as a rapidly increasing volume of sexual misconduct allegations are reported. Law enforcement and the special task force prosecutors are faced with legal and factual difficulties before any sexual misconduct allegations are sufficient for criminal prosecution. The legal elements of the alleged crime, the specific facts of each allegation, the existence of physical evidence, and the remedies available to the victims, are among the many convoluted factors that will dictate the ongoing investigations and prosecution of the allegations that are flooding Hollywood.

The Hazards of an Unregulated Cosmetics Industry

The cosmetics industry, unknown to many, is essentially not regulated by a federal regulatory agency. Cosmetics technically fall under the purview of the Food and Drug Administration (“FDA”), but there are few requirements that manufacturers must comply with. The FDA only requires that manufacturers comply with several labeling regulations so companies can avoid listing a product’s total ingredients, and the FDA does not require manufacturers to report health complaints. The FDA instead relies on direct reports of adverse events from consumers, which has the potential to delay remedying a potentially dangerous situation. A study published in JAMA Internal Medicine found that between 2015 and 2016, the number of complaints of adverse health results related to cosmetic products more than doubled from the previous years. Additionally, the FDA only has the equivalent of six full-time inspectors to monitor three million shipments of cosmetics that come into the United States each year. Last year, inspectors only conducted tests on about 364 of those shipments, and 20 % of those shipment that were inspected led to adverse findings.