Results 1 to 11 of 11

Thread: FDA Help

  1. #1
    Join Date
    Nov 2005
    Posts
    5

    FDA Help

    In the process of obtaining approval with TTB and ABC (California) for Microbrewery start up. One of the kind folks at TTB sent email reminding me that micro's need registration with FDA under bioterrorism act. Went to visit the fda website...what a labrynth. Anyone have to scoop on geting registered....specific web sites, contacts ect?

    Thanks

  2. #2
    Join Date
    Dec 2004
    Location
    Mukilteo, WA
    Posts
    304
    ???????????

    Your joking........right?

    I've never, ever heard that from the TTB folks. MicroBreweries are under the jurisdiction fo the Department of Agriculture, last I heard.

  3. #3
    Join Date
    Nov 2005
    Posts
    5
    I found it....website below. It's nice to know that beer (alcoholic beverages) and even water for that matter are now considred 'food'. Thanks FDA.

    http://www.cfsan.fda.gov/~furls/ovffreg.html

  4. #4
    Join Date
    Dec 2004
    Location
    Mukilteo, WA
    Posts
    304
    So.............a law changes...........and there's no mailer or phone call or E-mail or anything to let existing licensee's know. Our B2 Facility was just licensed a few months ago and there was NO mention of it then.

    Well........thanks for shairing. I'll have to read up on this a bit.

    Regards,

  5. #5
    Join Date
    Nov 2005
    Posts
    5

    Update

    It might be because you fall into one of the "excempt categories" on that web page it says folks who have a restaurant are excempt, or in my case doing out of their personal residence--but not within a residential dwelling.....gota protect the suds revenue..

  6. #6
    Join Date
    Jan 2005
    Posts
    121
    The FDA registration is totally separate from the TTB stuff...

    Technically, you have to register with the FDA if you use anything from a foreign supplier. This is from an FDA inspector...I argued for a while the brewpub exclusion...but it can be interpreted as the inspector sees fit.

    It is a simple registration form you fill out. If in doubt, do it, it will do no harm if you do, and at some point you can be inspected by the FDA, and possibly fined. So its just easy to get it out of the way even if you may be exempt (as stated in an earlier posting).

    Good Luck,
    B

    Go here & you can register online: http://www.cfsan.fda.gov/~furls/ovffreg.html

  7. #7
    Join Date
    Dec 2004
    Location
    Mukilteo, WA
    Posts
    304
    We have both a Brewery with an Alehouse and a Production Brewery. We don't use any foreign products.........so we're exempt?

  8. #8
    Join Date
    Oct 2005
    Location
    Woburn, MA
    Posts
    27

    FDA Registration

    Here's the language on the FDA's website. If you have a production brewery, you are not exempted from registration. It only takes a few minutes, and costs you nothing.

    Check out the link from above, the requirements are spelled out pretty clearly on the first page.

    Cheers,
    Mike



    The Law:
    The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act) requires domestic and foreign facilities that manufacture, process, pack, or hold food for human or animal consumption in the United States to register with the FDA by December 12, 2003.

    Who must register?
    Owners, operators, or agents in charge of domestic or foreign facilities that manufacture/process, pack, or hold food for human or animal consumption in the United States are required to register the facility with the FDA.

    Domestic facilities are required to register whether or not food from the facility enters interstate commerce.

    Foreign facilities that manufacture/process, pack, or hold food also are required to register unless food from that facility undergoes further processing (including packaging) by another foreign facility before the food is exported to the United States. However, if the subsequent foreign facility performs only a minimal activity, such as putting on a label, both facilities are required to register.
    Last edited by mlabbe; 11-30-2005 at 12:29 PM.
    Michael Labbe
    Brewery Engineer
    Lord Hobo Brewing Company
    5 Draper Street
    Woburn, MA 01801

  9. #9
    Join Date
    Oct 2003
    Location
    Pittsburgh, PA
    Posts
    407
    For what it's worth, here's my experience:

    I had trouble believing that my little micro was not regulated by the local health department, so I had them send me a letter to this effect...apparently if I don't serve the public, FDA registration is all that is required - according to them.

    After registering (free, as stated above), I have yet to have any communication from them whatsoever, and you only need to do this once.

    In my 13 years in the salad dressing industry, we never saw a visit from the FDA - then again, we never had any serious issues with our products. If an audit were to occur, I had the impression that it was a BIG DEAL. I'd say that the chance of an audit at a micro the size were talking about here is somewhere between very slim and fat-chance.

    Of course, now that I say this, I think I hear a knock at my door....funny how that works.

    Scott

  10. #10
    Join Date
    Dec 2003
    Location
    US
    Posts
    13

    FDA Regulations

    Given that some of us seem to not be too concerned with the FDA, I was wondering what others are doing about complying with the Food Allergen Labeling and Consumer Protection Act? I think that the compliance date is January 1, 2006 (but I am not sure). Has anyone changed their labels yet? Is anyone going to? Our last decision was to run through the labels we have (which is a lot) and then redesign them to note that the beers are “produced on equipment used to process wheat” or something like that.

    Also, as long as we are on the topic of FDA regulation, what about the provision in 2002 Bioterrorism Act regarding “ingredient tracking and maintenance of records”? Anyone? (If I recall correctly, small companies have a while—I think July, 2006—to come into compliance with this one.) We started a database that would allow us to comply, but have shelved it for now.

    Cheers,
    Andrew

  11. #11
    Join Date
    Oct 2006
    Location
    Madison, WI
    Posts
    43
    You have to register here:

    https://www.access.fda.gov/ffrm/ffrm...Y&pageNo=page8

    Register as a food facility. In the end you can print this out and send to the TTB, or wait until the interview when they'll ask you if you have registered - don't know if they ask you your registration # but you might want to have it on hand in case.
    Page Buchanan
    House of Brews
    Madison, WI

Posting Permissions

  • You may not post new threads
  • You may not post replies
  • You may not post attachments
  • You may not edit your posts
  •