“Though the mills of justice grind slowly, yet they grind exceeding small.”
FDA oversight is something that every topical patch creator needs to take into account. It’s true that the FDA is sometimes slow to review products on market. This can lull you into the false sense of security that what you’re doing isn’t against the rules when it is. There are products on the market today that violate FDA protocol. But what happens when the FDA takes action? They make you recall every bit of product, and they sometimes impose fines as well. So, how do you tick off the FDA?
Step 1: Make claims
This is the best way to tick the FDA off – make claims that they’ve reserved for OTC drugs on your non-drug product.
If you make claims about your product, you might as well start the ball rolling with a new drug application (NDA). You have to be able to prove those claims, prove them with batteries of tests, both human and animal. It costs millions of dollars to get a new drug to market because of the extensive testing and regulatory processes involved.
If you make claims about your product, it becomes subject to all the FDA regulations in regards to drugs. Here is an example of marketing claims ending in legal action. The FTC is a watchdog for the FDA, and will call their attention to mislabeled or misleading information.
Step 2: Combine an OTC drug with something else
The FDA gets ticked off when you mess around with the monographs.
We are often asked to produce topical patches which are a combination of already FDA-monographed OTC drugs and new ingredients. The FDA monographs spell out what can and can’t be used, and those must be followed.
We asked an FDA representative directly about this and were told:
Please be aware that one of the factors that are considered when reviewing a product to determine whether it is a drug is by the intended use, an example of this is ingredients that cause a product to be considered a drug because they have a well-known (to the public and industry) therapeutic use.
The manufacture or marketing of unapproved drugs in the U.S. is subject to FDA compliance actions.
Here is a helpful link from the FDA about OTC drugs, and what they are – and are not: https://www.accessdata.fda.gov/scripts/cder/training/OTC/topic2/topic2/da_01_02_0030.htm
We recommend that our customers who are interested in producing products combining already monographed drugs and other active ingredients begin the process of a New Drug Application – including investing in experienced legal representation.
We would be delighted to produce your OTC drugs in compliance with FDA monograph regulations.
Step 3: Use an active ingredient that is not “generally recognized as safe”.
The FDA gets ticked off when you use dangerous or semi-legal active ingredients in your product.
No, we will not make you a kratom patch, or one made out of ephedrine. The FDA regulations exist for a reason, and that’s to keep all of us safe. We have a list of ingredients that are a hard “no” – and we stand by that list.
Step 4: Call the patches “transdermal” rather than “topical”.
The FDA gets ticked off when you use legal words incorrectly. A transdermal patch contains a drug. A drug is something that has gone through the process of approval by the FDA. This includes millions of dollars in testing, trials, and approvals. Check out the FDA’s slideshow explaining what an OTC drug is https://www.accessdata.fda.gov/scripts/cder/training/OTC/topic2/topic2/da_01_02_0030.htm
Most of our customers are not in the OTC drug market. They make vitamin patches, nutraceuticals, and cosmetic patches. They don’t make claims – because they don’t want to create a drug. Because we’re careful, we use the word “topical” to describe our patches.
We use the same quality patch materials and manufacturing procedures when we produce a vitamin patch as when we manufacture a lidocaine or menthol patch. Not only have we been in the business for over twenty years, we consult with an expert who instructs on transdermal delivery and refuse to manufacture product that we know will be unfit for use in a patch.
Conclusion:
When you work with American Custom Technologies, you work with an organization dedicated to your success. We don’t want to tick of the FDA, and we refuse business that will. If you’re ready to work with a custom manufacturer who plays by the rules, give us a call today.