Category:

The Marketplace

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.

Powdered 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.

Dodging Pitfalls on the Path to Success: Sales Tax and E-Commerce Entrepreneur

Imagine you are an e-commerce entrepreneur and you log in to your reporting system to see how sales have been over the past week. You notice that you’ve made a good sale to a customer in the state of Illinois. As you are based out of Florida, you pause for a moment to marvel at the progress of technology and how your products can be delivered to someone’s home thousands of miles away from you. Little do you realize, but you may be on the hook for collecting and reporting sales tax to the California Board of Equalization.

The Balancing Act: Exclusive Ownership Rights and Digital Content Sharing

The Internet has given millions of people the capability to share information with each other with just the click of a button. People have grown accustomed to learning about current events, researching, and gathering information all through digital news sources. Unfortunately, the ease of the Internet has also created complications with regulating how users share that information. As technology rapidly advances, the legal limitations concerning intellectual property rights have become blurred, resulting in different interpretations of the Copyright Act of 1976. This has complicated user compliance and created difficult questions for the courts to answer based largely on law that was created before many of the capabilities of the Internet existed. There is a need for consistency and balance in this area of the law so that copyright owners are afforded adequate protection and the Internet can continue to serve as an information gathering, content sharing platform without fostering infringement.

What Google’s Genericide Win Means for the Future of Trademark Law

In 2014, in the District Court of Arizona, a judge ruled that “Google” was not a generic term and was eligible to receive trademark protection in Elliott v. Google. On appeal, the Ninth Circuit affirmed the district court’s ruling. In 2011, Forbes estimated that the “Google” trademark was worth $113 Billion; the trademark is worth more now in 2018 and the company’s trademark is likely its most valuable asset. The suit first ensued when Elliott purchased over 700 domain names with the word “Google” and after the company had successfully won a name dispute, Elliott filed to cancel “Google” trademarks. Elliott claimed that Google was a generic term and should not receive trademark protection. The Ninth Circuit’s ruling in this case will most definitely affect companies and entrepreneurs of all sizes, perhaps giving companies more protection than they were afforded in the past; what some are calling an unintended consequence.

Dodging Pitfalls on the Path to Success: Entrepreneurs and E-Commerce

The number of Americans who purchase goods online is steadily rising.  Recent data published by the U.S. Department of Commerce stated that retail e-commerce had increased by 16.2 percent in 2Q 2017 from 2Q 2016.  The report also stated that as a whole retail e-commerce had risen from 3.5 percent of total quarterly retail sales in 2008 to 9 percent as of 2Q 2017.  In hard numbers, 2Q 2017 e-commerce generated 111.5 billion dollars in sales.  Showing strong growth in under 10 years, these staggering numbers indicate that e-commerce has started to creep up on the traditional brick and mortar (BM) style of retail which has so long dominated the retail landscape.  One can only look at the financial data and stock charts of traditional BM stores as well as the REITs that own the malls and land these stores call home to see there has been some effect with this shift.

How Would a New Bipartisan Bill that Encourages the DEA to Increase Opioid Quotas Affect Drug Manufacturer Efforts to Remain Compliant?

After years in an opioid crisis, the United States now faces an opioid epidemic that has left the government and public desperate for relief and a workable solution. A group of senators hopes to be part of the solution with the introduction of a bipartisan bill that aims to better enable the DEA to establish opioid quotas. Despite already-present struggles to effectively manage its quota system and policies, the DEA would be given significantly more responsibility under this bill. Drug manufacturers, directly responsible for following DEA, FDA, and OIG regulations to hopefully resolve the epidemic, will need to grow their compliance efforts and create responsive solutions to remain both profitable and compliant.

FDA Faces Forward with Flexible Genetic Guidance

In recent years, the FDA has examined a record number of revolutionary medical devices, many of which have been genetic tests. Genetics has taken the world by storm. The medical world continues to look toward genetics as a promising next step in revolutionizing treatment, while the American public has shown a growing interest in learning more about themselves through services like Ancestry and 23andMe. In an effort to gain a foothold on the rapidly developing field of technology, the FDA has recently made efforts to modernize its approach by issuing new guidance to ensure the validity of these tests.