alcohol beverages generally

Under the new and important Food Safety Modernization Act (FSMA), FDA was supposed to commence food facility re-registrations yesterday. This was mandated by section 102 of the FSMA law, enacted in 2011. This piece of the FSMA puzzle is not off to a propitious start. It was bad enough that there was not much guidance or clarity about how this would work, before the October 1, 2012 to December 31, 2012 re-registration period began. But it’s even worse that the brief window for required and biennial re-registration began yesterday — and yet there is still no means by which to accomplish what is required. The renewal website was briefly available last week, for a few hours, then it froze, then it disappeared, to be replaced with an oh so calm assurance that:

Biennial Registration Renewal for Food Facilities will not be available on October 1, 2012.  We therefore will not be accepting food facility registration renewals at this time.

Natural Products Insider has explained:

FDA is delaying the registration renewals that are mandated under a 2011 law after the Grocery Manufacturers Association and numerous other trade associations recently sought guidance in meeting the registration requirements. “It would be extremely inefficient and costly for companies to re-register shortly after October 1st based on the...

TTB announced a big policy change — about gluten free — just before the Memorial Day holiday weekend. For many years before the announcement, plenty of companies have tried to make “gluten free” claims, but we still didn’t see any approved TTB labels referring to “gluten free.” A few weeks back, we thought we had one, when we heard a lot of buzz about Omission beer as above. But alas, even the Omission label has had a big omission when it comes to this particular claim. All this is about to change in a big way, as result of this TTB Ruling, released late last week. As a result, we may begin to see various gluten free claims on TTB labels in the very near future. To show the earlier TTB policy, a fairly recent TTB rejection is here, and it may help explain why Widmer did not come out and say it louder or earlier. TTB’s caution may well have been justified; Brewbound has explained:  “The release of Omission Beer comes just a few months after a study published in the Journal of Proteome Research found that eight commercial beers currently labeled as ‘gluten-free’ contained as much gluten as regular beer.” Brewbound further explained that there are plenty of other beers that seek...

Be careful about the five year rule as above and here. The rule says TTB formulas expire five years after approval. Not all formulas. Just the ones for imported products such as vodka, sake, and liqueur for example. This is in substantial contrast with TTB label approvals, permits, and domestic formulas. Generally speaking, they don’t expire unless the applicant changes something.

In our experience, TTB tends to explain the expiration date on the relevant formula approvals, but not in the regulations or widely elsewhere. An example is here. It can come as an unpleasant surprise, if you are seeking a new label approval more than five years after issuance of the formula approval, as in the case above. In the time period about 5-8 years ago, TTB would frequently allow a use-up in some cases where the formulas was expired. But, as suggested above, use-ups are much harder to get, in more recent years.