When Topical OTC Manufacturing Goes Wrong

This may be the oddest response to an FDA batch product record request. 

From warning letter. “recipes and procedures have been followed for decades. Though not in writing, they have been committed to memory.”

This company is an Amish topical OTC manufacturer that specializes in pain relief products. OTC products are permitted to make specified monograph claims like “pain reliever,” whereas topical cosmetic products are not. The OTC tradeoff is that they must follow the monograph (recipe) and specific labeling requirements. For example, a topical OTC product cannot make claims about its inactive ingredients and cannot make product claims that are not listed in the monograph.

How to tell if a product is an OTC topical product? Usually the “Drug Facts” label is a giveaway but in this warning letter the company appeared to be using a Drug Facts label but did not submit all their products to FDA for a National Drug Code (NDC) number. Companies are not required to add an NDC number to labels, but it is common practice. Here is where you can search the NDC database.

Key Takeaways:

FDA expects OTC companies to test their glycerin for the contaminants diethylene glycol (DEG) and ethylene glycol (EG). There have been dozens of warning letters about this, and the trend continues. Testing for these contaminants in glycerin is also a good idea for those using it in cosmetics or supplements.

Here is FDA’s “Testing of Glycerin, Propylene Glycol, Maltitol Solution, Hydrogenated Starch Hydrolysate, Sorbitol Solution, and Other High-Risk Drug Components for Diethylene Glycol and Ethylene Glycol” document.

Off-label claims are still “labeling.” If a company markets its product’s benefits that are outside the scope of approved monograph claims, expect the FDA to pay attention. This is also true for making benefit claims about inactive ingredients. Here’s a WLW post about this.

From warning letter. “Includes claims to relieves minor aches and pains associated sore throat, sinus trouble, and restless leg syndrome…… These indications described above go beyond the general intended uses for an external analgesic drug product.”

GMP processes are required. This warning letter mentions batch records, identity testing, proper labeling, and finished product testing, among other oversights.

Improper 483 responses lead to a warning letter. Many 483 responses can be handled before they lead to a warning letter, but in this warning letter, the company said they were going to take corrective actions, but did not “show their work.” This is a common but preventable error.

Lots more juicy manufacturing violations.