Category:

The Marketplace

Powered Caffeine – Friend or Foe?

Most Americans consume caffeine regularly. High amounts of caffeine are found in a wide range of drinks including sodas, coffee, and energy drinks. Like most things, caffeine is safe for most people as long as it is consumed in moderation. The dosage size of powdered caffeine has come under scrutiny mostly due to its potency. The Food and Drug Administration has notified powdered caffeine distributors that their products are potentially dangerous to consumers as they have the possibility of causing serious adverse health consequences, including death. The FDA’s notices required powdered caffeine distributors to accurately label and market their products ensuring they are in compliance with the law. Four of the five distributors removed their products from the market following the notices, and the fifth distributor no longer markets to consumers.

A Changing Gray Market Post Lexmark

On May 30, 2017, the Supreme Court issued a decision in Impression Prods., Inc. v. Lexmark Int’l, Inc. finding 8-0 to disallow post-sale restrictions on goods, and 7-1 on the matter of international exhaustion. The Court’s holding reinforced the doctrine of international exhaustion for patents, finding that the first authorized sale exhausts the patent holder’s rights to block importation. In theory, one could now legally purchase pharmaceuticals overseas at cheaper prices and import them to the United States.

FDA Nutrition Facts Label: Will the New Administration Approve a Change?

On May 20, 2016 the Food and Drug Administration (FDA) announced a new nutrition facts label for packaged foods, the first significant makeover in twenty years. The new label reflects new scientific information regarding our diets; such as the link between diet and chronic diseases like obesity and heart disease. This new label comes after three years of negotiations and proposed improvements between the FDA, scientists, and lobbying groups. Those in favor of the changes have pointed out that the old nutrition fact labels had no information to help consumers determine if they were complying with the U.S. Dietary Guidelines’ recommendations and that the labels did not reflect the necessary nutrients per day. These changes affect manufacturers as well as consumers. Manufacturers are not only worried about having to reformulate their foods, but also having to reconsider their ability to make certain nutrient content claims in advertisements and on packaging. Companies will also have to consider additional costs associated with packaging design, development of new artwork, regulatory consultation and review to ensure label compliance, reconsideration of inconsistent advertising, and human costs associated with potential new operating procedures and training to ensure compliance with the new regulations. In response to complaints from manufacturers, consumer advocates are reminding the White House Administration to remember that the FDA’s mission is protect the health of the American people not the bottom line of manufacturers.

Guest Post: A Post-Regulatory Recipe for Economic Leadership

by William Devine, Guest Contributor

Apple has developed and distributed a curriculum that will teach students at 30 community colleges around the country to write code and create apps. What prompts this gift? A belief that we all bear responsibility for sustaining a functional economy. At a time when some corporate leaders and their legal teams focus on the perils of overregulation, the greatest regulatory risk an enterprise confronts may not be high compliance hurdles, but rather the possibility that regulators can’t keep the economy functioning well enough for the enterprise to do its most commercially inventive and societally valued work.

Compliance in the Garment Industry: A Closer Look Into Bangladesh’s Factories

Compliance with labor laws is a major component of effectively and efficiently conducting business in the garment industry. Although there are a variety of areas, such as wage and hour compliance and disability compliance, human rights compliance issues are becoming increasingly prominent in recent times—especially in Bangladesh. The garment industry in Bangladesh came under international scrutiny in 2013 after the collapse of the Rana Plaza building, ultimately killing over 1,100 workers. This incident is considered to be one of the worst industrial disasters to ever occur and exposed many serious hazards that were occurring in Bangladeshi factories. Subsequently, some of the largest brands shifted to implement better conditions for workers.

The Baxter Settlement and its Implications for FCA Liability

Kaitlin Lavin Executive Editor Loyola University Chicago School of Law, JD 2017   In January, Baxter Healthcare Corporation (“Baxter”) agreed to pay $18,158 million after the Department of Justice (DOJ) brought suit for violating the Food, Drug, and Cosmetic Act (FCDA) and the False Claims Act (FCA). The Baxter case is unique because it was …
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Pharmaceutical Representatives in Chicago Soon to be Subject to Strict Licensing Requirements

Kimberly Seay Associate Editor Loyola University Chicago School of Law, J.D. 2018   On November 16, 2016, the City Council approved an ordinance amending Chicago Municipal Code § 4-6-010(c)(30), which will require the licensing of all pharmaceutical sales representatives in order to endorse pharmaceuticals within city limits and is set to take effect July 1, …
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SEC set to change how investors elect board members

Gilbert Carrillo Executive Editor Loyola University Chicago School of Law, J.D. 2017   The Securities and Exchange Commission (SEC) is expected to propose new rules that would make it easier for shareholders to vote on board candidates nominated by investors, versus those pushed by the company’s management. What impact could this have on compliance departments? …
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Could Apple Dive into the Medical App and Device Market Sooner Than We Think and How Will This New Technology Be Regulated?

Amanda Plowman Executive Editor Loyola University Chicago School of Law JD 2017 Alexander Thompson Assistant Editor Loyola University School of Law JD 2018   Apple has had a longstanding interest in breaking into the healthcare industry. Recently, Apple has hired a Toronto physician to work on expanding its health apps and Aetna will now provide …
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Theranos: New Compliance Program Hopes to Save the Company

Gilbert Carrillo Executive Editor Loyola University Chicago School of Law, JD 2017 Edmund Tyrrell Associate Editor Loyola University Chicago School of Law, JD 2018   Theranos, the American health-tech and medical-lab-services company, recently hired two executives to oversee regulatory compliance standards. The executives were hired following Theranos receiving multiple sanctions from U.S. regulators about the …
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