Important GMP Guidelines Proposed for Herbal Products

[Guest guest]

Dear Todd and All,

 

I thought I'd post this conversation about FDA proposed guidelines in order to hear your input. This is my comments to industry friends. Dave Engstrom felt some concern and wanted me to comment. The thread goes from bottom to top.

 

Emmanuel Segmen

- lots of vested interests

- Sunday, May 25, 2003 6:53 PM

Re: Important GMP Guidelines Proposed for Herbal Products

 

Dear C., H. and B.,

I've invited Dave Engstrom to our dinner table here. This is a continuation of our meeting at the Chinese restaurant in San Diego. Dave is an LAc living in Washington state and has had considerable other western style healthcare experiences in the realms of respiratory therapy. Dave's worried about comments below made by the Washington state Acu. Assoc. regarding FDA's enforcement of new guidelines. I felt that maybe you could put your thoughts together as I pass around the flak jackets.

My guess is that interstate commerce could be affected by the FDA proposals. I doubt that intrastate commerce will be so affected at least at first. What are your thoughts regarding GMP Guidelines from the ever provocative yet charming FDA?

My sense also is that enforcement will always be different in different states. Back in the early 1990s people got busted regularly and badly in Texas for selling herbal products. Then Chinese medicine became legal there, and things have been okay. I sense that there will be states where products will not be so readily sold, while other states will be okay. I can't imagine entire stores in San Francisco Chinatown getting busted or closed down. On the other hand in-state GMP certification is not hard to get. ACTA is a Taiwanese bottling plant in Hayward that bottles Kris Yang's stuff sometimes. They're GMP certified in CA state. I assume you guys have explored this little formality in order to sell outside the country.

Any thoughts?

Regarding Wash. Acu. Assoc.'s statement about the FDA banning ma huang, the FDA carries out legislative mandates. They don't make up their own rules. The FDA is required to propose guidelines according to Michael McGuffin within the next 10 years or so. They, like every other government bureaucracy, will "adopt" guidelines already established by academia and industry. Federal GMP is different from state GMP. It's nice to see an acupuncture association actually concerned about this. The bill in CA to regulate Chinese medicine is weaker than federal GMP, but about the same as state GMP.

 

Professor William would you have any soothing comments at this point? Hank's running a little low on snake wine.

 

All the Best,

Capt. Emmanuel

Inter-Galactic Poetry Consortium, Enforcement Division.

 

-

 

Sunday, May 25, 2003 12:46 PM

FW: Important GMP Guidelines Proposed for Herbal Products

> Hello Emmanuel,> > Here's something which I just received from my state association. Any> idea how hard core the FDA is going to be about herbs and how we> dispense with them?> > Dave> > > Acupuncture Association of Washington [jfrostad] > Sunday, May 25, 2003 9:47 AM> Undisclosed-Recipient:;> Important GMP Guidelines Proposed for Herbal Products> > The FDA has recently announced it's intent to implement Good> Manufacturing Practice Regulations on dietary supplements including herbal formulations. The proposal includes provisions for very stringent chemical assay, sterile environments, documentation, etc for the creation of these products. Given that it is a federal regulation, it does not supercede or interject itself into state law or affairs. These regulations do however affect> interstate trade of herbal products. Also it is the trend that states will follow the FDA's lead and implement either similar or duplicate guidelines.> > If you create and market a line of herbal supplements for sale - LISTEN> UP! This ruling is likely to put you out of business! If you sell products> which are distributed or sold into other states, you will need to do> chemical assays on every product's individual ingredients and on every> lot of finished product, you need to provide very stringent requirements for a sterile environment in which they are compounded, etc.. You need to> maintain a sample of every single lot of preparation for a minimum of> three years - every time you use a new batch of ingredient in your compounding you will have to do this. It is estimated by the FDA, a small manufacturer of herbal products will incur about $30,000 of new expenses each year due to these regulations.> > If you are an herbalist compounding formulas for your patients, these> regulations will have little impact on you - for the time being! These> regulations do not exempt compounding herbalists according to the FDA,> however if your trade is only within Washington, federal regs will not> apply. As I aforementioned though, states often adopt federal rules as> their own and it is very unclear as to how this will affect our current> practices. Also if you prepare a formula and ship it to a patient out of state, federal regulations are likely to apply.> > Also of concern is that herbal manufacturers are unlikely to continue> preparing custom formulations for you. Since they would technically> have to maintain a sample and chemical assay each preparation they made for you under these rules. We may have seen the end of custom encapsulations or granulations drop-shipped to our patients.> > These GMP rules are of good intent and are designed to address the> unfortunate rise in consumer complaints about dietary supplement> contents and quality. They are largely borrowed from the rules applied to the pharmaceutical industry; therein lies the problem, the herbal industry> is quite unlike the pharmaceutical industry in many aspects. The idea that> an herbalist needs a distinctly different formula for each patient, which> is often tailor made to their condition and complaints is lost in these> rules. These regulations need a provision which exempts the compounding herbalist who is preparing a product for an individual patient or a small group of patients.> > For the copy of proposed GMP regulations:> http://www.fda.gov/OHRMS/DOCKETS/98fr/03-5401.html> > For instructions on how to publicly comment by June 11th :> http://www.cfsan.fda.gov/~dms/supplmnt.html> > The time for legislation which will secure our right and competency to> practice herbal medicine as acupuncturists is exceedingly overdue.> Those that have been happy with the status quo need to recognize that the> status quo is changing by the minute. The FDA will in short order be deciding on the future of Chinese herbal medicine with GMP guidelines and by banning components of our herbal arsenal (e.g. Ma Huang). We need to> proactively position ourselves in the political arena by securing a clear right to use herbs in this state. This will require in the future, your solid> political and financial commitment to a legislative bill.> > John Frostad, L.Ac.> Acupuncture Association of Washington