tag:blogger.com,1999:blog-5738694062065682753.post184183049985111896..comments2023-11-28T06:26:40.953-05:00Comments on A Radicle: FDA cGMP project - overviewGuido Mase'http://www.blogger.com/profile/08186818316201584509noreply@blogger.comBlogger8125tag:blogger.com,1999:blog-5738694062065682753.post-87868981959901806102015-12-14T20:33:42.080-05:002015-12-14T20:33:42.080-05:00This may be a digression.
I am also wondering ab...This may be a digression. <br /><br />I am also wondering about the regulations for other types of herbal products that are not categorized as Dietary Supplements. Ear oils, eye washes, pessaries & suppositories; topical lotions, creams & salves... It is my understanding that these range across categories, including Cosmetics and Drugs. Herbal Teas are Food.<br /><br />The vast majority of my cGMP training revolves around 21CFR111. What are the relevant CFRs for Food & Cosmetics? As for the herbal "drugs", it seems that these must remain in the clinic, with the one-on-one consultation. I don't see a viable retail manufacturing option. I'd be interested in more info/ other opinions.<br /><br />Thanks ~Anonymousnoreply@blogger.comtag:blogger.com,1999:blog-5738694062065682753.post-58181433094155029842015-12-10T00:05:53.435-05:002015-12-10T00:05:53.435-05:00Great blog and I look forward to the future post. ...Great blog and I look forward to the future post. Thank you Guido!Anonymoushttps://www.blogger.com/profile/09192218235054141732noreply@blogger.comtag:blogger.com,1999:blog-5738694062065682753.post-28195819370476055232015-12-07T22:29:24.300-05:002015-12-07T22:29:24.300-05:00Summer - thanks for the offer. Would love to hear ...Summer - thanks for the offer. Would love to hear your input after I post some info on Wednesday. Now that we live in a time when FDA can cite you for "liking" a facebook post with non-compliant language (for example, "Wow! This tincture was great. It really helped me when I had a cold last week.")Guido Mase'https://www.blogger.com/profile/08186818316201584509noreply@blogger.comtag:blogger.com,1999:blog-5738694062065682753.post-85304201596076760072015-12-07T10:51:25.178-05:002015-12-07T10:51:25.178-05:00This is a very helpful post. After reading, I am i...This is a very helpful post. After reading, I am immediately struck by the irony that GMO foods are not required to be labelled, and yet herbalists are being required to jump through these many hoops to sell basically healthful products. Oh, my, what Big Money can buy!Anonymoushttps://www.blogger.com/profile/13732519648791678391noreply@blogger.comtag:blogger.com,1999:blog-5738694062065682753.post-41804110098320237162015-12-07T00:11:22.363-05:002015-12-07T00:11:22.363-05:00Hi Guido, great post! I was at the workshop and ro...Hi Guido, great post! I was at the workshop and roundtable discussion on FDA + GMP compliance at IHS. I'm so grateful and happy that you're providing this information to the public. I have a fairly strong understanding of DSHEA compliance on social media. I would be happy to share information, and give concrete examples if that is helpful.Summer Singletaryhttps://www.blogger.com/profile/12397068542509480168noreply@blogger.comtag:blogger.com,1999:blog-5738694062065682753.post-58087942865617585612015-12-03T18:50:59.838-05:002015-12-03T18:50:59.838-05:00thank you I am a very small company with the FDA o...thank you I am a very small company with the FDA on my back and feel like I am drowning, so all of this is helpful.Anonymoushttps://www.blogger.com/profile/10096462212349195405noreply@blogger.comtag:blogger.com,1999:blog-5738694062065682753.post-4622406455817922082015-12-03T15:53:25.974-05:002015-12-03T15:53:25.974-05:00Unfortunately, though what you say makes perfect s...Unfortunately, though what you say makes perfect sense, FDA doesn't see it that way. There has been a lot of effort to try to exempt tinctures from microbiological testing based on the alcohol percentage - and these efforts have failed. There are bacteria that can (perhaps) survive. Theoretical analyses don't cut it based on what I've seen. And, contamination could be introduced during bottling, etc... and somehow persist in the product. I agree it makes no sense, but there you go.<br />The same is unfortunately the case for heavy metals. Presses, bottling lines, just dust could introduce heavy metals into the product - even if the raw material is clear. And just because the soil is clear doesn't mean the herb, once harvested, is clear: what if it sat in a burlap bag next to some tractor exhaust by mistake for a while?<br /><br />Finally, FDA will probably never codify acceptable responses. There's been some clarity on language for labeling, but that's about it. FDA says we need specifications, but will never tell us what they are - because there are many potential satisfactory possibilities. Interpretation is done mostly by the district offices - the inspector is really just a data collector and messenger, and makes no interpretations without checking in with superiors. Guido Mase'https://www.blogger.com/profile/08186818316201584509noreply@blogger.comtag:blogger.com,1999:blog-5738694062065682753.post-60367748429745803882015-12-03T09:34:13.429-05:002015-12-03T09:34:13.429-05:00This is awesome, thank you. It seems that if you a...This is awesome, thank you. It seems that if you are buying from or growing herbs on a certified organic farm, with documentation of soil tests and everything the farm has to prove to gain organic certification, this should satisfy the question of heavy metals. <br />And if we can show scientific proof that bacteria is killed at 60% alcohol then that should be acceptable to them as well. <br />It seems like these 2 areas are something we could try to work with the FDA to accept as solutions to avoid expensive lab testing?<br />I understand interpretation of the regulations is subjective to the inspector right? Is the FDA open at all to input from us and codifying acceptable efforts into their rule book?Jonah Ruh Robertshttps://www.blogger.com/profile/10208745661768662015noreply@blogger.com