GRAS & GRAE: Safety & Efficacy of Over-the-Counter (OTC) Medications

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  • 0:43 GRAS/GRAE
  • 4:26 What Is Safe & Effective
  • 6:20 Lesson Summary
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Lesson Transcript
Instructor: Artem Cheprasov
This lesson will explain what the term 'generally recognized as safe and effective' (GRASE, GRAS/E, GRASE/GRAE) means and how that is determined. We will also discuss over-the-counter medication approval.

Testing for Poison

Rulers now and long ago had servants that were food testers. These poor chaps had the terrible role of having a bite of the king's, queen's, or dictator's food before the ruler was to chomp down on it him or herself. Sometimes, as you can imagine, this didn't turn out well for the food testers. The reason the rulers did this is because they wanted to ensure the food was safe enough to eat. That's obvious.

Well, in a similar spirit, U.S. laws and regulations try to ensure that medications that you can obtain are also safe and effective for use. I think that's a good thing, and as a result, there's thankfully no need for a personal medicine tester!

Generally Recognized as Safe and Effective

GRAS/GRAE (GRAS/E or GRASE) is an abbreviation for generally recognized as safe and effective. This is a legal term that describes specific forms of 'old' drugs that no longer need serious oversight by the FDA, or Food and Drug Administration, in order to be sold in the U.S. and be used without medical supervision. That is to say, they can be sold OTC, or over the counter.

One way a drug can be approved by the FDA for OTC marketing is by using previously approved ingredients or ingredients found to be generally safe and effective when used for certain purposes.

Therefore, the OTC drug must not only use the appropriate ingredients but also for the appropriate category of drug. Drug categories include topical antimicrobial and antifungal products, antacids, laxatives, sleep aids, cough and cold remedies, and many more. Basically, it's the stuff at the local corner pharmacy's OTC drug aisles.

It's sort of like cooking a good meal. If you're comfortable using ingredients that have proven to be useful and delicious for you over and over again in the past for a particular type of dish, then you're more likely to use them again compared to new and unfamiliar things you'd use with caution.

Again, these OTC drugs are not considered new drugs because they use ingredients or combinations of ingredients that have been previously determined to be generally safe and effective for a specific purpose. Therefore, these products do not need further FDA clearance prior to sale so long as they use such ingredients for their intended and previously approved purposes and satisfy certain other requirements not so important for this lesson.

Another way for a drug to be marketed for OTC use is by way of an approved NDA, or new drug application. What happens here is that normally a new prescription drug, a drug that can only be used under medical supervision, needs to undergo extremely difficult, serious, and extensive testing and oversight in order to ensure safety and efficacy. And rightfully so, by the way.

Going back to our cooking example, if you were told to use a new spice or some sort of ingredient you've never come across before, you would almost certainly use it very carefully, maybe in very small amounts, and give someone you don't like a taste of it first just in case.

To be frank, even after this long and arduous testing, once a prescription drug is marketed, it may take many years of data collection, statistics, and experience to truly figure out the efficacy and safety of a drug in the real world, so to speak. This data collection may one day reveal that a product is safe enough to be used OTC. Of course, not all prescription drugs will reach this point, and some may be withdrawn after becoming OTC after new data comes in questioning its status as an OTC product.

Prescription drugs that do not become OTC at all may fall into one of these categories:

  • They are too toxic or harmful.
  • They are habit forming.
  • They treat medical conditions a normal person cannot be expected to self-diagnose and/or properly treat.

What Is Safe and Effective?

Overall, in order to be labeled as GRASE, a drug must satisfy three important criteria.

First, the drug product in question should have undergone well-developed scientific studies that establish it as safe and effective. This is something we just discussed.

Secondly, these same studies should be available in scientific literature to be examined by qualified experts.

Thirdly, these qualified experts must reach a consensus that, based on all of these studies found in the scientific literature, the product is safe and effective for its intended use.

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