'Just in Time' is Not Always a Good Thing

By Len Monheit
[email protected]
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The principle of 'Just in Time' was originally used to describe inventory management theory where the objective was to reduce on-hand inventory, to instead rely on value chain partners to provide inventory just as it was required, either for production or for sale. More recently, the term has been used to describe computing theory where behind the scenes 'processing' leads to information at the users fingertips - just as they need it.

Many businesses operate with a variation of this philosophy as they move from crisis to crisis or try to navigate a series of shifting priorities. Companies typically 'deadline watch' whether it's for the submission of advertising or budgets, or for the completion of various projects, internally or externally. And of course, there's also the preparation for release of quarterly financial results and dealing with the fallout.

This year, there's another deadline pending, and from all appearances, the same behavior pattern is emerging. Companies, it seems, are relying on an eleventh hour blitz to allow them to keep operating. December 12th is approaching – And as of this week, less than 10 percent of affected companies have registered their facilities with the FDA in order to comply with the Food Safety legislation that requires all foreign and domestic facilities that manufacture, process, pack or hold food for consumption in the United States to hold a registration number to attach to each and every one of their shipments. This legislation is directly relevant to manufacturers, processors, packers and holders of dietary supplements and their ingredients.

Perhaps there are those that figure a last minute reconsideration by the FDA will extend the deadline for registration. Maybe there are some still wrestling with the decision on whom to appoint as a US agent. Some may feel that they'll deal with it December 11th, and others may believe someone else will do it for them.

Whatever the case, as of this week, FDA has informed its audience that it has only 10 percent or 37,000 registrations comprised of 17,000 domestic facilities and 20,000 foreign establishments. When you consider that conservative estimates suggest that there are 200,000 facilities in each of the domestic and international categories that must register and be processed prior to December 12, it doesn't take much of a leap to anticipate the logistical nightmare that's brewing - in the next 4 weeks.

While some of you will undoubtedly wait until December, I hope that this industry takes the initiative to complete its registrations in the next week if not sooner. The process is not a difficult one, there are only a few decisions to be made and this is one case where leaving it to the last moments will not make it any easier. And with holidays coming, business issues arising, budgets being finalized and all other regular activities, dodging this crisis now could be mission critical. Make sure you complete the registration in the next few days and perhaps even more importantly, ensure those suppliers you depend on to do so as well.

For those seeking US agents as required by this legislation, to date we have been informed of five groups offering these services (If you know of others, please have them let us know or these groups can add themselves to the NPIcenter database (http://www.npicenter.com/dept.asp?ID=3651) :

1) AHPA (American Herbal Products Association) www.ahpa.org
Contact: Natasha Hall, [email protected]

2) Ullman, Shapiro & Ullman, LLP www.usulaw.com
Contact: Steven Shapiro ([email protected]) or Marc Ullman ([email protected])

3) Robert C. Lehrman, Attorney www.food-agent.com
Robert C. Lehrman 202-756-2989

4) Biostar Nutriceuticals - www.biostarnutriceuticals.com
[email protected] 650-697-6875

5) AAC Consulting - www.aacgroup.com

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