Build Testing Methods Into Your Formula
Ever since General Schneiderman’s flawed but effective attack on our industry, finished products have been under more scrutiny than ever before. As a lab that offers a wide variety of finished product testing we have co-experienced several FDA 483 notices received by our clients who chose not to invest in custom testing for custom products. While the average FDA auditor, badge in hand, is not generally trained in either botany or Phytochemistry, they are skilled at finding loose threads of a sweater and pulling them until it’s completely unraveled. If your finished products have loose threads it might be a good idea to keep reading. If you are developing a finished product, keep reading. This article might just help you stay out of trouble. Spoiler alert! It involves the FDA.
I recently had the honor of speaking at the 2016 Rocky Mountain Dietary Supplement Forum and on the second day we were graced by the presence and presentations of three FDA agents. Many questions were posed. Many rants were squealed. Many stories were told. When I finally found the right opportunity to ask a loaded clarifying question, I did: “ If a finished product has a claim on its label, for example, 80 mg of caffeine per serving or 20mg of resveratrol per serving, do you have to have scientifically valid test methods to prove the claim is accurate?” The answer was a stern YES, delivered in such a way to indicate that everyone there should already know that. I then asked if the same product did not list specifics details on phytochemicals (80 mg of caffeine per serving or 20mg of resveratrol per serving) does a scientifically valid test method have to be developed? The answer was a caustic NO, again delivered as if the answer should have been known. I concluded my soap box session stating that the marketing department should have a “behind the woodshed spanking into compliance” to better understand the implications of their fairy dusting or even including data that is not critical yet nearly impossible to test. The FDA agreed, without sarcasm.
Essentially, how you market your finished product will determine the testing you need to perform. Marketing departments, throughout many industries, play a significant role in driving product development. They are geniuses at telling the consumers what they want to have in their product and the formulation chemists in the back are constantly playing catch up, as are the chemists at your favorite contract lab.
If you state a specific Genus and species you are now obligated to prove that’s what is in there. If you make an exact claim of a particular ingredient you are now obligated to prove that.
Reality check! Methods do not exist for your complicated finished products. Testing the caffeine content in green tea is fairly simple. Numerous methods exist and are available. Testing the caffeine in a product mixed with several other ingredients requires custom method development for a custom formula. It’s a simple requirement that in actuality can be really complicated to meet, but meet it you must.
I always say you can’t test quality into a product. To truly build quality into a product takes more than quality ingredients in therapeutic amounts. Determining how it will be tested should be part of the process and evolution of a final formula. Some finished formulas are far more complicated to test than others, so here’s what you should ask yourself: did Dr. Oz tell you that some new ingredient is hot so you now want it in your finished product? Well, skip it because that’s not a good enough reason to take on the difficulties it brings. Go with time -tested ingredients and keep it simple.
Must you incorporate a new novel branded ingredient? Well then the manufacturer should have data on testing that ingredient and you can and should expect them to assist with method development for your unique blend with their unique ingredient.
Are you using a contract manufacturer to not only make the product but also provide quality data? Well, the good ones have in house labs and should be able to provide you with methodology to prove each and every claim on that label. If they cannot, I suggest you kindly move on to another. If it costs more then take a big gulp of reality because that extra investment is a pittance compared to the cost of the legal support you will require when a fresh 483 is hand delivered and the time and resources needed to rebuild your reputation.
There are many factors that go into creating a finished product. With the goal being a safe and effective product that delivers on consumer expectations while meeting regulatory requirements, it’s critical to start with the highest qualified ingredients and having accurate, reproducible and scientifically valid testing at each step and again at the end.
Elan Sudberg, CEO
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