So…FDA came by to visit. It all went fine but most of what went on did not make sense.
First, they do not tell you what they are there for, or if they do, it is a fairly vague referral. In my case I sold a material four years ago that was fully declared as non-compliant for cosmetic OTC GMPs* but compliant with Food GMPs. A company used it in, what we all thought, was an acceptable way. There were no complaints, nothing filed with FDA. No harm, no foul.
The FDA ran a random sample on a finished product that led them to a small brand and then to a small lab and then to me.
Again, the product caused no damage to anyone (and probably never would have – this said with my physiologist hat on).
It is clear that there is really no immediate risk from the ingredient. In fact, it was imported and FDA clears all imported ingredients so they already cleared it for sale in the US. If there had been any issues, they would have shown up 24 months prior when they did the first random test. No one was hurt and FDA can’t even really say if there is a problem. They said that they are “assessing” the ingredient.
Secondly, they just kept digging. I finally made the local FDA Supervisor answer the question: “what is your authority?” I then asked her to please show me in the regulation why they were there. I shipped a duly labeled ingredient with a C of A that fully disclosed it’s characteristic – so I was compliant. I had not even changed the package it arrived to me in.
Her final answer was that she could not make me hand over any documents and that I had done nothing wrong, although she kept implying I was in the wrong in the way she cited the regulation. I did cooperate up to the point that I thought it was appropriate and that if they wanted to go back to the supplier of the suspect item, they could.
So – what is FDA doing? The vague rumor is they are looking at how organic and natural products are made and trying to come up with some “guidance.” In this case those rules will apply to safety, not whether or not the organic or natural claims are accurate or truthful. If they seriously want to do this they need to work with us, not disrupt small businesses, and pick on the smallest sector of the industry. We do pay their salary – or am I missing something?
I don’t see the FDA looking into whether or not 1, 4 Dioxins are accumulating in our water ways as a result of the millions of tons of surfactants going down drains every single day or how we can get Bisphenol A and other endocrine disruptors out of the production stream.
We sell only organic (plus three non-GMO) ingredients. The organic cosmetic industry is probably less than .005 of the total cosmetic industry – the rest of the cosmetic industry continues to put out finished products that pollute both the planet and our bodies.
So…who the hell is the FDA protecting by investigating our teeny segment of the industry?
They certainly are not protecting the people who want safer products.
*OTC-GMPs = Over the Counter Drug Good Manufacturing Practices.