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The Mysteries of R&D, Part II: Why Do They Always Say “Not Ready Yet”?

By: Art Rich, PhD
Posted: November 5, 2010, from the November 2010 issue of GCI Magazine.

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Safety Testing (all products): The FDA requires that the safety of the product must be adequately substantiated. If not, the product may be considered misbranded and subject to regulatory action unless the label carries the following statement: “Warning—The safety of this product has not been determined.” A warning declaration such as that, which is required if the proper testing has not been performed, is not something that you want to have to put on your product. The safety testing will also provide assurance that the product will not produce adverse consumer reactions.

The Human Repeat Insult Patch Test (RIPT): RIPT is an industry standard for evaluation of safety. The overall time allotment is approximately six weeks to get the final report. Basically, a patch containing the product is applied to the same portion of a subject’s back every other day for nine applications. The site is observed for signs of redness (irritation response). The subject is then allowed to rest of a period of time (10–14 days) before placing a product-containing patch on another area of the subject.

This second phase measures whether there is a sensitivity reaction.

Cumulative Irritancy Testing: A 21-day or 14-day test, a patch/product is placed on a subject’s back every day for 21 days. The degree of irritation (redness, or worse) is evaluated daily. The advantage is that this is a relatively shorter test. The downside is that sensitization is not evaluated, so that a complete safety profile is not developed.

In vitro Testing: In seeking to remove the human subject from the testing scheme, various in vitro programs are being developed. At this point in time, there has been no government recognition of any as an acceptable protocol to replace the established procedures.