Here at the Law Office of Vincent Miletti, Esq. and the home of the #UnusuallyMotivated movement, we take pride as a resilient and dependable legal services firm, providing such services in both a traditional and online, web-based environment. With mastered specialization in areas such as Employment and Labor Law, Intellectual Property (IP) (trademark, copyright, patent), Entertainment Law, and e-Commerce (Supply Chain, Distribution, Fulfillment, Standard Legal & Regulatory), we provide a range of legal services including, but not limited to traditional legal representation (litigation, mediation, arbitration, opinion letters and advisory), non-litigated business legal representation and legal counsel, and unique, online legal services such as smart forms, mobile training, legal marketing and development.

Still, we, here at Miletti Law®, feel obligated to enlighten, educate, and create awareness, free of charge, about how these issues and many others affect our unusually motivated® readers and/or their businesses. Accordingly, in order to achieve this goal, and as part of our continued commitment to you, we have committed ourselves to creating authoritative, trustworthy & distinctive content, which is featured as videos that are posted on our YouTube Channel https://www.youtube.com/channel/UCtvUryqkkMAJLwrLu2BBt6w and blogs that are published on our website WWW.MILETTILAW.COM. With that, the ball is in your court and you have an effortless obligation to subscribe to the channel and sign up for the Newsletter on the website, which encompasses the best way to ensure that you stay in the loop and feel the positive impact of the knowledge bombs that we drop here!

In the spirit of updating our various series with fresh, verifiable, and credible content, which looks to not only educate, but also deliver in a sense that only Miletti Law® can, this blog introduces you to our video titled “Dissecting An FDA Claim For Misbranding and Adulterating Part 2.” In Part 1 of this series, we hammered on the basics of understanding how to navigate through an FDA claim for misbranding and adulterating, particularly witch a focus on what qualifies something as a drug. In a nutshell, we mentioned that the labeling you put on your product and what you say it can do comprise potential criteria that will be used to classify it as a drug. Remember that it may not be close to being a drug, in both shape and form, but because of the labeling and the way you describe it, then it can qualify as a drug as per the definition provided under the FDA act.

In our second video, we have discussed two more crucial concepts that you need to know about in order to understand an FDA claim for misbranding and adulterating and how to go about it. Before we hammer on these concepts, we would like to acknowledge that we understand that the content in the two videos is complex. While the FDA itself, as you all know, is not particularly a complex statute. However, it is very formalistic and tenuous, which makes everything around it nasty complex. However, just like in our past blogs, we do our best to decipher the information and provide you with a refined and usable product.

That being said, let us now look into these concepts.

An existing “drug” vs. a “new drug”

Under the FDA Act, something is classified as a new drug when its composition has not met the GRAS (Generally Recognized as Safe) standards. Something is considered GRAS if qualified experts within the field or the scientific community generally understand it and have conducted lots of studies and research on it, which provides lots of proof on it. Otherwise, if it is not classified GRAS then a problem arises because it is not considered to be safe. This is why it is being regarded as “new” drug to imply that it has not met the GRAS criteria. Remember the criteria used to classify something as a drug under the FDA act, 21 U.S.C. 321. You can read more about this in Part I of this series on our blog accessible through https://milettilaw.com/blog/f/dissecting-an-fda-claim-for-misbranding-and-adulterating-part-1.

However, there is an exemption to where something is classified as a new drug. If the investigation of this particular product is used for the advancement of science and for the advantage of society.

Mislabeling/misbranding of a “drug” vs. a “new drug”

As indicated on the video’s title, the statute talks about mislabeling, which is also called misbranding. Under the FDA statute, a drug or new drug is usually considered misbranded or mislabeled, if it has inadequate directions for its use and, as a result of inadequate warnings against its use, it is impossible for you, as a layperson in society, to make use of it safely.

So, what does “adequate directions” mean?

Here is the rule: If a drug or new drug has adequate directions, then its label clearly and satisfactorily states the purposes and conditions for its use so that even a layperson can use it safely, effectively, and efficiently. However, a twist comes in following a presumption in this country that if anything has to do with a new drug or prescription, then it is impossible to put proper labelling or instructions on it no matter what. This is because of the notion that if it is a misbranded drug, then it can only be reviewed, controlled, and used under the advisement of a licensed professional.

Here, the statute is asking if a layperson can go ahead, acquire this drug, understand the label and all the instructions prescribed, and self-medicate safely, effectively, and efficiently. This is because the drug in question is a new drug and, therefore, it is impossible for the layperson to use it or self-medicate in the manner mentioned above. For this reason, no matter the label you put and the instructions for use that you provide, you are going to be wrong.

In a nutshell, the most critical things to consider when faced by an FDA claim for misbranding and adulteration include whether it is a drug and is based on the four categories mentioned earlier (based on the FDA act’s criteria discussed in Part I), if it does not meet any exemptions, and whether it has been classified as a new drug or not (meets the GRAS standards).

Feel welcome to view our video at https://www.youtube.com/watch?v=U0dyQ-BPAD8

Stay tuned for more guidance and counsel. In the interim, reach out to us at the Contact Us page for answers to your questions and/or comments and business legal representation.

Always rising above the bar,

Isaac T.,

Legal Writer & Author.