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The intricacies of FDA regulations

The Federal Drug Administration (FDA) provides regulation for food, drugs, medical devices, radiation-emitting products, vaccines, animal and veterinary products, cosmetics, and tobacco products.  Just in the radiation-emitting products category alone, they are responsible for regulating firms that manufacture, repackage, relabel, and/or import medical devices sold in the U.S. That is a lot of oversight! The […]


EU Food Allergen Labeling

In the United States, we are quite familiar with the Food and Drug Administration (FDA) and its involvement in food and drug production. FDA is responsible for “protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, the nation’s food supply, cosmetics, and products that […]


Pediatric Labeling Changes

“A pediatric labeling change refers to any update to a product’s labeling to add information about safety, effectiveness, or dosing for children.” As you can imagine, the number of labeling changes to pediatric medications has increased over the years due to more research, new findings, and better information. There are a number of legislative initiatives, […]


What’s the skinny, on skinny labels?

We recently wrote about the Hatch-Waxman Act and the negotiation that occurred to allow for longer patents for new drugs on the market.  Now we dive into skinny labels, what they are, and how they may prevent brand-name drug manufacturers from delaying the competition. In this blog, we will share the skinny, on skinny labels. […]


The Hatch-Waxman Act and pharmaceutical costs

How is it that we have a “prescription drug price crisis when 90% of prescriptions are filled with generic drugs that cost, on average, $1 a day? The answer: The remaining 10% of prescriptions have an average cost of $20 a day and account for 80% of all prescription drug spending.” The intent of the […]


Front-of-Package Nutritional Labeling

“The FDA is prioritizing its nutrition initiatives to ensure people in the United States have great access to healthier foods and nutrition information” enabling healthier food choices. One of these initiatives is front-of-package nutritional labeling. This initiative would not be in lieu of the full nutritional facts labeling typically found on the back of most […]


How the FDA handles drug shortages

  We have heard a lot through the news lately of drug shortages, mostly over-the-counter cold and flu medications, but what is the process when prescription drugs are in short supply?  The FDA works closely with the pharmaceutical industry and stakeholders to “prevent drug shortages and lessen the impact on patients anytime there is a […]


Changes to Nutrition Facts Label

For consumers, reviewing nutritional labels is commonplace though what to pay attention to has changed over the decades. We often think of these labels as a convenience but in reality, they are a requirement. The FDA reviews and makes changes to the nutrition facts label when needed.    The latest updates came in 2016 “to […]


$600M in unclaimed can and bottle deposits

There are a few states that still pay consumers for recycling aluminum and bottles.  California, Connecticut, Hawaii, Iowa, Maine, Massachusetts, Michigan, New York, Oregon, and Vermont, though California has found a vast number of unclaimed recyclables— $600,000,000 worth to be exact. So, what is California planning to do with this overabundance of unclaimed funds? They […]


Industrial Chemicals Found in U.S. Fast Foods

It’s no secret that fast food really isn’t good for you.  And if you needed another reason to limit these types of food in your diet, a “first-of-its-kind study” was recently published stating that popular fast foods contained chemicals linked to a long list of serious health problems. “Researchers at the George Washington University and […]