Question Of The Week: How do I know your products are safe?

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Permalink Reply by Happy Face Dermaceuticals on November 2, 2009 at 9:18am

The answer is simple - in the absence of controlled testing you have absolutely no idea.

GRAS list compounds are a place to start, but relying on GRAS listing is no guarantee - bisphenol A and phthalates for example. Natural products are not safe just because they are natural - would anybody want poison ivy extract in their face cream?

I've been looking into the costs of doing this kind of testing and with full analytical support, FDA compliant GLP testing in three species etc. the cost is ~$650,000. A small scale acute toxicity study in rats is $30,000 to $40,000.

So for the small operator that only really leaves personal experience and widely used materials that, even though they have not been rigorously tested, at least have a good history of anecdotal safety.

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Permalink Reply by Happy Face Dermaceuticals on November 2, 2009 at 2:25pm

Testing for antimicrobial activity according to FDA and EPA guidelines for hand sanitizers runs about $80,000.

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Permalink Reply by Cindy Jones on November 2, 2009 at 9:29am

A great question because there are so many that think natural and organic equate to safe, which doesn't. Its easy to spread falsehoods on the internet and they are believed unfortunately.
Is your product free from bacteria and fungus that (although natural) could harm your customer or degrade your product? This is something many people do not think of. Bacteria and fungus are microscopic organisms that you cannot see. The only way to know is to have your product tested for microbiology. Products are not expected to be sterile however, but they are expected to have very low counts. In case you didn't know, the use of preservatives first came about because of people going blind from using mascara that was not properly preserved. There have also been documented situations where hospital patients have gotten serious infections from nurses using unpreserved products.

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Permalink Reply by Kathleen W. on November 2, 2009 at 10:02am

Cindy,
I am with you on this one totally. You never know. I definately prefer products with a bit of perservative in it.
I usually list on my page I use both non-and with. I also list to make sure you read the ingredients so you know if you have an allergy to any of the ingredients in the product before buying.

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Permalink Reply by Sarah Powell on November 2, 2009 at 10:15am

Snowdrift farm sells small, sterile test kits that the home crafter can use to test a product at intervals to ensure their preservative system is working. They cost $40 each. Obviously, small crafters with etsy businesses and net profits under 10,000 are hardly going to be able to afford testing at 650,000 or even 40,000.

This is not an easy issue, but obviously very important. Another reason why having insurance is so critical

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Permalink Reply by Sonsa Rae on November 2, 2009 at 10:21am

I would hazard a guess that over 90% of the people who make handmade toiletries do not have their products tested. One of six things can be done: 1. Use enough preservative to kill absolutely anything that could possibly be in the product, 2. Make products that do not require the use of a preservative, 3. Buy products for re-sale that someone else makes that they have tested, 4. Contract your products to be made by someone else who will test them for you, 5. Make small quantities of product using less of the preservative with an expiration date 30 days out, or 6. Make large batches to have tested by an outside facility that offers this service. Most of the individuals I spoke with did not understand that they need to have each batch tested, not just the recipe itself. The only way to know is to have a sample of each batch tested. Each batch should also be numbered and a sample of that batch should be kept for a period of time (1-2 years) for quality control. If a problem does arise, the sample can be tested. At least you'll know how the product originally went out the door. What people do with it afterward is often what can cause a problem. Using sealed containers helps. Products that can be pumped or squeezed out, avoiding contact with all outside contaminants, helps immensely with this issue.

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Permalink Reply by Dannette Evans on November 2, 2009 at 12:42pm

Thanks, your reasoned response gives me the information I need to make an informed decision about my product line and the choices I will have to make.

Thanks again.

Danne

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Permalink Reply by Betty Elliott on November 3, 2009 at 9:02am

I believe I've read that even if a product is made without water (like sugar scrubs) and the customer introduces water from hands while bathing, bacterial growth can occur. Water creates the perfect environment.

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Permalink Reply by Victoria Beckner on November 5, 2009 at 8:04am

I only sell soap. So, I speak about clean manufacturing practices. I tell them that when they open the shrink wrap, they are the first bare hands to touch the soap. Period.
I have sample jars of cream soap to smell and so forth, but everything else has been shrink wrapped to keep it as contaminant free as possible.
I point to my ingredients and ask if there is something there I can explain. I don't have problems with this issue in large part due to the shrink wrap.

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Permalink Reply by Kim Grustas on November 5, 2009 at 11:07am

It is imperative if you are going to manufacture skin care that you have the highest quality testing procedures.
We not only test during manufacturing we have an outside laboratory test each batch produced.
Yes, it is an expense but one we will not compromise. Should larger chains every carry your products you will need this documentation.
Best!
Kim

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