Q: Do FDA-mandated GMPs for supplements ensure herbal product quality?
A: It’s hard to argue with the GMPs. I think they’re sound; they help ensure a good paper trail, and some assurance that what’s on the label is really in the bottle. However, GMPs don’t mean that the end product is a good product, especially with botanicals.
Let’s say your supplier delivers a standardized gingko product. Most botanicals are traded as powders, and you can’t identify a powder visually. You have to do some kind of analytical test to verify what it is; that’s the point of the GMPs. You can send it out for high performance liquid chromatography testing, and that will make the FDA happy, but the supplier could have spiked the product to give you good analytical readings, and if you don’t have a good lab, it can appear as though you have what’s really on the label. Testing doesn’t guarantee that you have what you think you have.
Q: What measures can manufacturers take to ensure quality raw materials?
A: The best approach is to buy whole, easily identified botanicals that you can track from farm to the bottle. We contract directly with growers, so I have a chain of custody where I can track an ingredient back to the soil and the place. Unfortunately, we're the minority.
You have to learn to identify plants, and you can only do that if that plant is complete. If you get a whole gingko leaf, there’s nothing else that looks like a gingko leaf. However, even having the right materials isn’t a guarantee of quality. You could get a whole gingko leaf from China that’s brown, or you could get a hand-harvested gingko leaf in the prime season with a high flavonoid content. The latter is a whole lot more therapeutically effective, but both meet GMPs. Manufacturers need to make sure that the crop is from the most recent harvest and was harvested correctly and dried correctly to ensure efficacy.
Q: What should retailers do to ensure quality products on their shelves?
A: Of course, every manufacturer is going to say that they follow GMPs, so you have to ask tough questions. Are they buying whole botanicals? Are they buying close to the harvest date? If they’re using standardized powdered botanicals, do they retest their suppliers’ raw materials? Are they looking for residual solvents and other contaminants?
Somebody at the retail level needs to get educated about GMPs through trade shows or through reading so they can ask manufacturers tough questions. And manufacturers should have someone, an herbalist or quality control person, who can respond to those tough questions quickly without having to look something up; they should know this stuff.
Retailers should also look for third-party certifications that go beyond GMPs. Nothing really substitutes for having third-party certification. If the manufacturer has a third-party company come in and audit and independently verify the raw materials, that’s important. For example, we’re NSF GMP-certified [an independent third-party verification of GMP compliance], we’re kosher-certified, we’re organic-certified, even OTC drug-registered. This all goes beyond FDA’s supplement GMPs and really does ensure quality.