Posts Tagged ‘fda’
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 old procedures, only to find out later they have to do it all over again after FDA clarifies the new procedures in its guidance,” wrote Leon Bruner, senior vice president, science and regulatory affairs, and chief science officer of the Grocery Manufacturers Association, in a Sept. 21 letter to the Office of Management and Budget. “Thus, it will be difficult, if not impossible, for food facilities to effectively and efficiently meet FSMA’s registration renewal mandate without guidance from FDA.”
This leaves several hundred thousand food facilities around the world, plus their required agents, with a looming and ever closer deadline, but no means by which to comply with the law.
A few weeks earlier, in late summer, two groups sued FDA “for declaratory and injunctive relief regarding the failure by [FDA] to promulgate final regulations by mandatory deadlines contained in [FSMA].” The non-profit food groups said:
FDA has missed not one, not two, but seven critical deadlines, and counting, in failing to implement FSMA’s major food safety regulations. FDA has submitted several of these unlawfully delayed regulations to [OMB], where they are still awaiting approval. However, FDA has authority to promulgate the regulations without OMB approval.
Despite this bump in the road, here’s what food companies around the world can do, to avoid missing the renewal deadline. Make sure you have a reputable FDA food agent, if you are based outside the US. Make sure that agent has up-to-date information about your facility. You should be especially careful if your agent hides its true identity, or has vaguely (and confusingly, aggressively, and in many cases not so vaguely) pretended to be affiliated with FDA. Some of the agents charge as much as $900 in the first year. If your US importer, or a friend, has handled this for you in the past, it may be time to reconsider and at least make sure your agent is aware of the changed environment. The law can subject the US agent to substantial liability for the costs related to recalls and re-inspections.
For more information about agents and registration, go to www.food-agent.com. The site is affiliated with Lehrman Beverage Law, a law firm in the Washington, DC area that has been acting as US agent for hundreds of companies around the world, since the earliest days of the FDA agent requirement, almost 10 years ago. Unlike many other leading agents, food-agent works within traditional attorney ethics rules, has moderate fees, and tries to avoid confusing food companies about their identity or their relationship with FDA.
October 19, 2012, 9 pm Update: FDA has announced that “Biennial registration renewal for food facilities will begin at 12:01 a.m. on October 22, 2012. At that time, the system will be accepting food facility registration renewals.”
We are starting to get a lot of questions about TTB’s future. Over the years I have marveled and wondered if Bill Clinton or George W. Bush spent much time pondering the fate of ATF or TTB (and, for example, the intricacies of the label approval process). Well, the Obama Administration clearly thinks about it a lot. Late last year, Wine & Spirits Daily wrote:
Obama’s Office of Management & Budget (OMB) is considering “the impact of folding TTB’s tax enforcement and collection functions into IRS, to be proposed in the Budget and implemented in FY 2013,” reports Kane’s Beverage News Daily. The TTB has until Dec 28 to submit a proposal to the OMB “analyzing the feasibility and appropriateness of this proposal, including a discussion of how the missions and goals of these two agencies could be combined.” Furthermore, TTB is to review whether its “regulatory and health-safety functions” can be transferred to the IRS or even the FDA.
Since then, there has been almost nothing in the press about this important story. As recently as today, Google News has not much of any consequence on this issue. I don’t see much on TTB’s website or newsletters. A few days ago, however, The Gray Report set forth some new information on this topic, and it provoked a lively discussion in the comments. W. Blake Gray wrote:
The politics of this potential elimination of the TTB are fascinating, and ultimately why I don’t think it will happen even if Obama wants it. … In this climate where government austerity is seen by many as a good thing, Obama could gain some chips by trying to eliminate a federal agency. … However, the Republicans in the House seem dead-set on preventing him from achieving anything at all, and that will only intensify leading up to November. I think they’ll reflexively oppose it. … But what a conflict it poses philosophically for Republicans. Deregulation is a party tenet — but how would social conservatives react to restrictions being taken off of Demon Rum?
The 2013 Federal Budget is set to be released in a week. According to The Washington Post, “The budget is traditionally released on the first Monday in February — which is Feb. 6 — but the administration has pushed the release to Feb. 13.” Last month, Wine & Spirits Daily wrote:
The TTB has since submitted a plan analyzing the proposal to the Office of Management & Budget, but nothing is public or final at this point. … There are two current speculations as to how the reorganization would go down. One, the organization and all of its functions would be taken in one lump sum and deposited into a corner of the IRS. Two, the TTB’s tax enforcement and collection function could go to the IRS, while its regulatory and health-safety functions could go to the FDA. This is the most extreme scenario. One thing that almost everyone agreed one, however, is that an united alcohol beverage industry has enough power to squash any such proposal if it indeed made its way to Congress.
At least with the TTB the industry is the priority. With the FDA you’re with 25 or 30 other industries.” Even more problematic is that the FDA may have some anti-alcohol types, whereas the TTB is a neutral force.
One of the biggest complaints last year was the TTB’s slow response time when it came to approving labels – a result of less funding by Obama and inevitable lay-offs. As a remedy, the TTB proposed shifting its duties more towards enforcement rather than label pre-approvals, but the industry fought it. Instead, it seems the industry would rather the TTB speed up the COLA process than do away with it.
[I]t doesn’t seem likely that disbanding the TTB would save much money because theoretically it would require the same amount of people to complete the same functions now performed by the TTB, which “is pretty bare bones as it is.” Furthermore, the “TTB is one of the few revenue generating agencies in the federal government. They make a lot of money. It would be hard to split it up effectively.”
Three years ago, as part of the 2010 Budget, the Obama Administration flirted with the idea of imposing user fees for various TTB activities, and not much came of it. In our opinion, to the extent this is some kind of business school-type exercise, or thought experiment (as in, show cause why there should not be a shakeup), it could be useful. But, if any reorganization would take several hundred people from one entity and replace them with a similar number at one or more other entities, it is hard to imagine that the costs would not outweigh the benefits.
I do believe this Olde Bay Saison label raises at least a few legal issues. First of all, I sure hope the brewer had permission to use this famous branding. McCormick owns the Old Bay seasoning brand and probably would not have a sense of humor about any unauthorized uses. Even if the beer is loaded up with the same seasoning, and even if the reference tends to be flattering. I can not imagine that changing one letter (from Old to Olde) is likely to help any more. The total production for this ale with spices seems to have been tiny, so that may help somewhat more to avoid problems.
A second legal issue is that, such a beer needs formula approval, before label approval and production. To get formula approval, it is usually necessary to provide a detailed ingredient list to TTB. It can be very difficult for anyone to get ingredient details (beyond what FDA typically requires on a food label’s ingredient list) about famous and protected products like Coca-Cola, Angostura Bitters, or Old Bay. TTB typically needs to check for artificial flavors, allergens, colors, and use-rate limitations, and this can be very difficult to do without a complete ingredient list of the sort that McCormick would be unlikely to provide to the brewer here (The D.O.G. Beverage Co. of Westminster, Maryland). So this raises the question of whether this beer actually contains Old Bay seasoning, or TTB did not require details about all 18 ingredients, or D.O.G. somehow got hold of the ingredient list.
The video features John Stossel, Nick Gillespie, and Rhonda Kallman (owner of Moonshot, Beer with Caffeine). Among the highlights:
Rhonda says FDA’s ban is “clearly a case of the government over-reaching. … My Moonshot Beer is nothing like these Four Loko drinks.” FDA:
didn’t fully research it … they put the onus on the small entrepreneur to have a scientist. … It’s 5% alcohol by volume and less than a half a cup of coffee of natural caffeine. It’s a great combination. … They won’t stop here. Where will they stop?
Sen. Schumer won’t stop at calling these drinks a “blackout in a can.” He goes further to suggest they may be a death wish in a can. And here, Iowa takes a step toward going much, much further (toward banning any mixture of cola, coffee or Red Bull with alcohol, at bars and restaurants).
For the time being, Moonshot has ceased production due to [the FDA ban]. … Three of the products targeted are high alcohol, high caffeine and high sugar “juice” drinks sold in oversized 23.5 ounce cans and targeted to underage drinkers. The fourth was Moonshot ’69 – an all malt, craft-brewed pilsner beer that bears absolutely no resemblance to these high alcohol, high caffeine sugary drinks. … There is nothing new about adults combining caffeine and alcohol. Who hasn’t enjoyed a rum and Coke, Irish coffee, Kahlua or espresso martini? The question should be what levels are appropriate.
In a massive and coordinated action yesterday, the Federal Government moved to favor Red Bull and pummel other drinks with caffeine.
FDA handed a giant gift to Red Bull here.
The FTC handed a humongous present to Red Bull here.
Other actions are expected imminently, as legions of other regulators rush in to exaggerate the dangers (it looks like soda, it’s “loaded with caffeine,” it’s like a “plague” and “toxic”) and ignore evidence to the contrary. This follows many state actions in recent weeks. Presto, problem solved! We eagerly await the evidence that young people cut back on alcohol, or cut back on co-consumption of alcohol with caffeine. We hope it’s better than the current leading study; it purports to highlight the dangers of the pre-mixed products such as Four Loko, Liquid Charge, Joose and scores of others — without ever having examined any such products. Instead, the O’Brien study reviewed products so different they are not even within the scope of yesterday’s governmental actions (none of which, after some dexterous sleight of hand and misdirection, stopped it from instigating the above actions).
We believe caffeine and alcohol raise plenty of important public policy issues, whether they are combined or not, and they warrant serious deliberation. But many of the deliberations so far reflect political pressures more than an even-handed review.
November 18, 2010 Update: TTB lands another blow, against caffeine added to alcohol beverages, here.