Functional Ingredients: You push the industry for higher quality standards. Is progress being made? What are the biggest barriers?
Stacy Eisner: I do see a lot of progress, especially in response to the new GMPs, with companies paying heightened attention to quality and regulatory compliance. But I think many companies are in a tough spot with respect to the requirement to confirm botanical identity because they buy their ingredients in powder or extract form, which can make it very difficult to establish identity with certainty.
Fi: The botanicals industry has been talking about method validation since at least the 1990s. How does it look today?
SE: A tremendous amount of progress has been made, at least for quantitative testing of single ingredients. There are still many, many more ingredients used in the industry than there are official AOAC fully validated methods, but good labs can generally ensure accurate and reproducible results. In addition, the advent of readily available primary standards has been a huge help. My company has much less trouble these days in obtaining consistent analytical results from different laboratories.
On the other hand, quantitative testing of complex blends and finished products remains difficult. You have to adjust the method for the individual matrix, and if the adjustments aren’t well documented, validated and shared, then results can be inconsistent. Unfortunately, I don’t see this getting easier in the near future.
Fi: You’ve been involved for years in efforts to keep the small herbal products businesses viable as regulatory demands increase. Where does this stand today?
SE: Overall, I think the new dietary supplement GMPs are reasonable. I don’t think they’re perfect, but they cover the main things companies need to worry about to ensure safety and quality. However, I’m concerned that during inspections, FDA employees are sometimes going beyond what is required and are creating unnecessary burdens.
I’ve heard that some FDA inspectors are questioning whether an ingredient lot can be used in manufacturing a finished product if the ingredient lot has an expiration date earlier than the supplement batch’s expiration date. Ingredient expiration dates are often assigned arbitrarily by the vendor to minimize their ongoing liability and ensure stock turnover, not because the ingredients actually deteriorate. And except for highly inert ingredients, microencapsulations, or other special cases, various ingredients in the formula can shorten or lengthen the shelf life of other ingredients.
So what matters is whether an ingredient meeting all its specifications at the time of use will maintain its required potency or function in the formulated product until the end of the shelf life of the product, not how quickly the ingredient deteriorates when stored in isolation.
Fi: I’ve heard you have a horse, can you tell me about him?
SE: I have two horses, Compañero and Meridien. They’re as opposite as can be. Meridien is a tall, lanky ex-racehorse who is thin as a rail (no matter how much I feed him) and is constantly snorting and spooking and tripping over his own feet. He’s been known to fall down just because he spazzes out and forgets to mind where his feet are!
Compañero, on the other hand, is a short little Andalusian who gets fat eating air, is as calm and level-headed as a judge and as athletic as a gymnast. They’re like Mutt and Jeff, but they’re best buddies and can spend hours play-fighting and nibbling on each other. They’re my favorite source of relaxation and diversion.