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Tuesday June 10th, 2014


Regulatory Affairs


Regulatory Affairs, is it Really the Anti-Sales Department?

This article in the Q2 Intermountain West Society of Cosmetic Chemists Newsletter, illustrates how organized and detailed planning is critical at the onset and throughout all stages of product development.


Formulating Regulatory Friendly Products 

   By: D. Scott Taylor

“Some ingredients in this product can only be used in drugs, you’re going to have to switch preservatives, organic claims will only be valid in the United States, fragrance free will have to be changed and the names for the exclusive ingredients will have to receive INCI names from the Personal Care Products Council (PCPC) before the ingredient panel can be added to the label. Or, you can sell it and hope you don’t get caught.” After my comments, I looked around the room at the disgruntled faces of the executives as Regulatory Affairs, a.k.a. “the department of sales prevention”, had once again lived up to its inglorious moniker.The product development team had been so excited to tell me that the formula was ready, the contract manufacturer was in place and the pilot batch would soon be complete. All they needed was to register the product in their current markets and compile the documentation. The testing had been carried out so that they could make specific claims on the products and additional testing for subsequent claims was also scheduled. The products were scheduled to be launched in the United States within the next six months. Fifteen additional countries were to be ready within 18 months. The problem wasn’t the timeline or the formula efficacy; the problem was the product didn’t meet the regulatory requirements for some of the international countries.

Regulations are different from country to country and are especially diverse for preservatives, whitening agents, sunscreens, colorants, testing methods, classifications and claims. After that meeting, I regretfully informed R&D that they should cancel the pilot, if possible, change the preservative system and total % of preservatives in the formula, apply for INCI names, cancel the new ingredient/finish product testing on animals and cancel the tests for acne, anti-bacterial properties and rosacea/skin irritation reduction.

Simply put, they had a product they couldn’t export with claims they couldn’t make coupled with a very frustrated product development team. Even though this was a big hassle, a valuable lesson was learned and new SOPs reflected this knowledge. When a new product is coming out or a product needs to be
reformulated, there are a few questions that need to be answered before formulation occurs.

1. Is this product going to be allowed in our international markets?

2. What testing methods must be used for safety requirements abroad?

3. Will the introduction of certain ingredients change the classification of the product?

4. Which claims can be made and what are the substantiation/testing requirements?

5. Do the manufacturers have the necessary documentation/certifications for the registration processes?

6. Are there any changes in the foreseeable future that will affect the acceptability of this product? 

If these questions are answered, R&D will have the basis upon which to build their formulation. Ingredients can be selected from acceptable manufacturers and reformulation will only have to occur for organoleptic or technical reasons.

Prevention vs reaction - it is much easier and much more cost effective to apply sunscreen than get rid of melanoma. By coordinating formulation activities with regulatory research, you can optimize your chances of having a viable formula for the US and international markets. Not only will you save money, mitigate the risk of reformulation and save some hairs on your head, you will also be able to spend more time preparing for next year’s golf tournament.



Product Development and Regulatory really can work in harmony!


Lisa Swain

Director of Business Development

Mariposa Labs LLC


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