Most people think of Over-the-Counter (OTC) as cough syrup or something you can buy from the drugstore without a prescription. While that is true, it can also refer to drugs and other products with \u201cmedicinal\u201d ingredients. A few examples of OTC products are decongestants, topicals that relieve itches, and treatments for common bodily aches, like Tylenol.<\/p>\n\n\n\n
But, most people don\u2019t think of sunscreen, hand sanitizer, or eczema lotion as being an OTC product, much less a \u201cdrug.\u201d At Tropical Labs, we receive many inquiries for OTC products, with sunscreen being one of the most common requests and one of the harder custom formulas to bring to market in terms of expense, compliance, and time involved.<\/p>\n\n\n\n
OTC custom formula manufacturing is neither viable for small quantity orders (less than 5000 units), nor for fast product launches. If you have been yearning to develop and launch the next innovative OTC product, read on. This article will walk you through Tropical Labs’ process of R&D formulations for OTC products. Our goal is to give you a clear understanding of the expense, development time, and regulations associated with OTC product development. <\/p>\n\n\n\n
The good news is: With our multi-decade experience, Tropical Labs can help you stay fully compliant while also avoiding the OTC pitfalls that can snare you. <\/p>\n\n\n\n
It\u2019s pretty simple: If you make a claim on your label, it must follow rules and regulations set forth by the Food and Drug Administration (FDA) for OTC products. You may think you have the next best eczema lotion, but even just calling your product an \u201ceczema lotion\u201d is a claim. What about an SPF30 lotion? With this product, you are claiming that it will protect against sunburn according to the parameters set forth by the FDA for SPF30. Hand sanitizer? Your claim is that it kills germs. In short, if there is a claim, there is a path of compliance you have to follow, or you risk drawing the attention of the FDA or the Federal Trade Commission (FTC).<\/p>\n\n\n\n
When advertising OTC products to target markets, manufacturers create claims describing the functions, applications, and ingredients the items contain. OTC product claims have to be substantiated by the FDA monograph. This means, you can only claim what the monograph allows for. If you marketed, even if true, claims that were not covered under the monograph, they would be considered misbranded by the FDA.
If you have ingredients that you think are the \u201ccure\u201d or efficacious for an ailment, the easiest way to bring a new formula to market and make that \u201cclaim\u201d is to add the ingredients in the inactive ingredient section and select a standard monograph active. For example, Eczema has a monograph for salicylic acid.
If you have essential oils that you think are the key to the cure, you would add them in the inactive ingredients but use the monograph for salicylic acid as an active, to make the claim for Eczema relief.<\/p>\n\n\n\n
We have often had clients report amazing discoveries with a combination of natural ingredients and they want to \u201cclaim\u201d and report the success of their anecdotal evidence, but they cannot. Even if, for example, rosemary extract grew back hair, you would not be able to make this claim without finding a monograph that already exists and is approved for the claim of hair regrowth.<\/p>\n\n\n\n
There are three ways to safely make product claims:<\/p>\n\n\n\n