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Generally, Miletti Law® specializes in three legal areas, including Employment and Labor Law, Intellectual Property, and e-Commerce (legal and regulatory). Accordingly, with regards to the third, we introduce you to our new video titled “Dissecting An FDA Claim For Misbranding and Adulterating Part 1,” which is accessible through the link provided at the end of this blog. It happens that regulatory agencies, including, but not limited to the EPA (United States Environmental Protection Agency), CARB (California Air Resources Board), and FDA (Food and Drug Administration), comprise a common area of e-commerce and regulatory industry. As the title of the video suggests, the discussion focuses on the FDA.

As a preliminary matter, we would like to mention that regulatory agencies, as a matter of fact, are extremely formal and detailed. In a way, the whole aspect of these agencies can be described as counterintuitive because, contrary common knowledge, they are a different kettle of fish altogether. This is because, when a regulatory agency passes laws and regulations, especially under the FDA act, they must incorporate as much as possible, to adjust for the never ending variety and industry advancements , but, at the same time, be specific enough to speak to particular features. If the law is too broad, it becomes hard to narrow it down and it is almost impossible to have ingenuity or development in the industry. On the same note, if the law is too narrow, then the crooked boys and girls get away with it. For these reasons, there exists a fine line between how aggressive a law could be versus how lax it could be. That being said, let us dive right in and understand an FDA claim for misbranding and adulteration of commodities, specifically drugs.

What Qualifies Something As A Drug?

For starters, keep in mind that a drug is a legal term. Thus, a substance, in and of itself, must meet certain requirements or criteria to qualify as a drug. For instance, the fact that something has been made in a lab does not qualify it to be a drug. This is why we said that these aspects are counterintuitive because, contrary to your knowledge, these agencies and the manner in which they work and create and pass rules and regulations are a different kettle of fish altogether.

Under the FDA act, 21 U.S.C. 321, a substance is considered a drug if all four of the following categories are met.

  • If the substance is recognized in an official record book;
  • If the substance is intended for use in the diagnosis, cure, medication, treatment, or prevention of any disease in humans or animals (note that each of these terms is very broad by its definition);
  • If the substance is an article other than food (or a derivative of food); and
  • If the substance is intended for use under any manner in (1), (2) or (3) above.

Based on this criteria, it is clear that, as opposed to what many people think and know, the FDA is very formal and detailed in the definition of a drug. However, technicalities also arise in some cases. For instance, thinking about some of the provisions above (if the substance is an article other than food (or a derivative of food) or if the substance is intended for use in the diagnosis, cure, medication, treatment, or prevention of any disease in humans or animals), there exists an exception if there is a truthful & non-misleading label that has been made in accordance with another statute.

Let us say that you have a given product and it is on a list, is intended for use in the diagnosis or treatment of some kind of disease as per the label, is something other than a food stuff, and is intended to be used under any manner preceding these sections. However, there is a truthful anonymous preceding label on the packaging of your particular product, then it is considered an exception to a drug. For instance, if the description talks about general well-being from the consumption of a particular nutrient or ingredient, it must meet three requirements, including (1) the label has to be truthful and non-misleading (the product leads to wellbeing as in our your product), (2) that the manufacturer has substantive information on this statement (e.g. this vitamin is good for the immune system), and (3) the statement contains some kind of standard disclaimer regarding the use of the product.

If this is the case, then your product falls outside the definition of a drug as provided for under the FDA act. It also means that you can buy it over the counter, has all the formalities that it needs, and gets out of the regulation.

Simply put, 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.

We invite you to review our video at https://www.youtube.com/watch?v=4uhjFxpdF3A

Stay tuned for Part II of this installment. In the interim, please reach out to us with questions and/or comments at the Contact Us page!

Always rising above the bar,

Isaac T.,

Legal Writer & Author.