How I wrote the first ever Safety Assessment

How I wrote the first Cosmetic Product Safety Assessment
It seemed like just another day in the lab.

I spent the biggest single chunk of my career at Stiefel Labs, first as a formulation scientist then as a lab manager. Stiefel is now a division of Glaxo, but back then it was the world’s biggest dermatology company.

Most of its products were topical pharmaceuticals, but it did have a number that fell into the cosmetic category for one reason or another. Like all pharmaceutical companies it had a big regulatory team who would keep track of the regulations. Pharmaceutical projects are long, and so it is essential to keep ahead of the game on what the rules are. This is necessary for pharma projects which can stretch to five years or more. But they applied the same philosophy to the cosmetic regulations. As a result we tended to look at new requirements almost as soon as they got into the public domain.

One example of this was a new requirement that came along for cosmetics to be assessed for safety prior to their launch. Initially there wasn’t much detail on what exactly this entailed. It just said that prior to launch products’ safety should be assured by a suitably qualified person. There wasn’t at this stage any suggestion that this needed to be a formal report, nor that it should be done by anyone from outside the company producing the product. This was a level of ambiguity that the regulatory team didn’t really like very much, but rules are rules.

The first and obvious question was who was suitably qualified. There were plenty of candidates available. The team was about 80 strong altogether with over half of us being scientists of some description or other. There were pharmacists, chemists, biologists, biochemists and toxicologists available, all of whom certainly had qualifications and for whom a case could be made for their suitability. But the most popular option was me. I managed the formulation lab and was a formulator. I had a very good knowledge of how cosmetics work, and the properties of the ingredients that go into them. The only person who raised a counter argument was me. I was already busy and didn’t want extra paperwork.

But the senior management overruled my objections and to my dismay I had an extra duty to add to my list.

The next question was how exactly the assessment should be carried out. There was at this stage neither guidelines to follow nor existing examples to emulate. I was on my own. It wasn’t even obvious that the assessment should take the form of a report. But I decided that if something needed to be done, it would be best to record it in writing.

I settled down and came up with a format more or less straight away. I started with the quantitative formulation. This is the individual ingredients in order. This was already something that needed to be done to come up with the ingredient list, so that wasn’t too much trouble. I then decided to margin of safety calculations on the preservatives, and after a bit more thought, on actives. So that became a table just below the formulation. I then went through each of the ingredients in turn and wrote a quick monograph of what I knew about their safety profiles. A formulator has information like that in his head. It is the sort of thing you think about and look up every day. Stiefel had a very well stocked library – this was before the internet was a big thing and certainly before it was a reasonable place to look for information. I filled in the gaps with whatever I could find on hand.

I finished with a couple of paragraphs of reasoning about how the product might be used and how it would be safe in those uses.

I think Word 2.0 was out by this time, so it would just about have been possible to have done the report as a word processed document. But I chose to do it all on paper and send it off to the typing pool to be drawn up.

I didn’t give it a huge amout of thought and certainly never considered that these assessments were going to become such a big deal both for me and the industry. Had I known I would have kept a copy. I have no idea if it still exists somewhere in the Glaxo vaults. I did later make some photocopies that I gave to some other people who were facing the same issue I had of not knowing where to start. It was quite likely they were subsequently passed on. If anyone has a copy I’d love to get one back. Looking back, I realise the reports I do now still have the same outline. I also started keeping the information I gleened on raw materials, and some of that information is still on my database and I still use it.

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