FDA To Look Into Safety of Caffeinated Alcoholic Beverages

The Food and Drug Administration (FDA) notified nearly 30 manufacturers of caffeinated alcoholic beverages that it intends to look into the safety and legality of their products.

“The increasing popularity of consumption of caffeinated alcoholic beverages by college students and reports of potential health and safety issues necessitates that we look seriously at the scientific evidence as soon as possible,” said Dr. Joshua Sharfstein, principal deputy commissioner of food and drugs.

Under the Federal Food, Drug, and Cosmetic Act, a substance added intentionally to food (such as caffeine in alcoholic beverages) is deemed “unsafe” and is unlawful unless its particular use has been approved by FDA regulation, the substance is subject to a prior sanction, or the substance is Generally Recognized As Safe (GRAS). FDA has not approved the use of caffeine in alcoholic beverages and thus such beverages can be lawfully marketed only if their use is subject to a prior sanction or is GRAS.  For a substance to be GRAS, there must be evidence of its safety at the levels used and a basis to conclude that this evidence is generally known and accepted by qualified experts.

The FDA alerted manufacturers to the fact that the agency is considering whether caffeine can lawfully be added to alcoholic beverages. The FDA noted that it is unaware of the basis upon which manufacturers may have concluded that the use of caffeine in alcoholic beverages is GRAS or prior sanctioned.  To date, the FDA has only approved caffeine as an additive for use in soft drinks in concentrations of no greater than 200 parts per million.  It has not approved caffeine for use at any level in alcoholic beverages.

The FDA requested that, within 30 days, the companies produce evidence of their rationale, with supporting data and information, for concluding that the use of caffeine in their product is GRAS or prior sanctioned.  FDA's letter informed each company that if FDA determines that the use of caffeine in the firm's alcoholic beverages is not GRAS or prior sanctioned, FDA will take appropriate action to ensure that the products are removed from the marketplace. 

In the past year, Anheuser-Busch and Miller agreed to discontinue their popular caffeinated alcoholic beverages, Tilt and Bud Extra and Sparks, and agreed to not produce any caffeinated alcoholic beverages in the future.

The federal agency with primary responsibility for regulating alcoholic beverages, the Treasury Department's Alcohol and Tobacco Tax and Trade Bureau, requires that alcoholic beverages contain only ingredients that satisfy FDA's requirements for use. In late September, the FDA received a letter from 18 Attorneys General and one city attorney expressing concerns about caffeinated alcoholic beverages.

For more information visit: http://www.fda.gov/Food/FoodIngredientsPackaging/ucm190366.htm     

Courts force U.S. reckoning with dominance of GM crops

Paul Voosen, New York Times (Oct. 8, 2009), writes that 90% of U.S. soy and cotton crops are genetically engineered (GM crops).  In addition, 85% of the corn crop is also genetically engineered, and it is found throughout the food system. 

     “These crops are safe to eat. The science on that is unequivocal, even in Europe, where a moratorium on new GM crops has existed for a decade. And by most accounts, GM crops have been an economic benefit to farmers, simplifying field maintenance and reducing the number of hands needed for weeding.

     “But as these crops have come to dominate the agricultural landscape, farmers who eschew their growing -- for ethical, organic or trade reasons -- have found themselves at a loss, frustrated by regulators and the majority of fellow farmers who have accepted GM crops as the new normal. . . . For the past two decades, the government has argued "essentially that there's no difference between a GM crop and its nonmodified sibling," said Alison Peck, a law professor at West Virginia University.

     "’Their arguments all sort of flowed from this presumption -- that these two kinds of crops are fungible,’ Peck said.

     “Two recent decisions out of the Northern District of California are the first-time acknowledgement by any federal entity of a difference between GM and non-GM crops, Peck said. The latest ruling, on the GM sugar beets of Willamette Valley, came down late last month and will move into the remedy phase at the end of this month. Both rulings -- the first, upheld several times on appeal, came down in 2007 -- found the regulatory apparatus used by the Department of Agriculture severely lacking. USDA, along with the Food and Drug Administration and U.S. EPA, oversees GM crops, using jury-rigged laws written well before the invention of biotechnology. Unlike Japan, Europe or even Russia, the United States has never passed legislation on GM crops.”

     USDA came to view GE and non-GE crops as identical, fungible. If the farmer wanted to keep GE-genes out of their field, it was that farmer’s burden to provide for buffer zones and other measures to keep out pollen drift. This could have serious economic consequences for organic and other non-GE farmers.

     To make the point about keeping out pollen, Voosen makes a interesting comparison to cattle ranching. “In the eastern part of the United States, traditionally, farmers have been obliged to fence in cattle. In the West, meanwhile, landowners are required to fence out roaming herds. The same distinctions apply to crops. Europe has been busy erecting a complex regulatory apparatus requiring farmers to ‘fence in’ their GM crops with isolation distances and liability funds. With no regulations, the United States has in effect required non-GM farmers to ‘fence out’ GM crops, placing the economic burden on conventional farming.”

  A copy of Judge Jeffrey S. White order in Center for Food Safety, et al. v. Thomas J. Vilsack, et al., is available here.

High Fructose Corn Syrup - 'Natural' or Not?

Dave Babcock has written an excellent article on the debate over whether high fructose corn syrup is natural:

So, let's say I was making you dinner, and in preparing one of the ingredients was "fixed to a column by the use of a synthetic fixing agent, glutaraldehyde."  Even if I told you that I washed off all the "unreacted glutaraldehyde," would you be willing to call the dinner I made you "natural?"

If you wouldn't, don't eat with the decision makers from the FDA. 

Kudos to Marler Clark for presenting us with FoodSafetyNews.com.

More on natural claims is here: USDA Reopens Comments on Use of "Natural"  and here: Health Canada Guidance on Food-like Natural.

I Was Dooped by the Loops of Froot

What a shock to find out that Froot is not fruit. What next, no good luck from Lucky Charms? However, I am (pretty) sure Fruity Pebbles do not contain real pebbles.

Kevin Underhill at Lowering the Bar (legal humor, seriously) shares some humor at the expense of yet another consumer alleging being duped into thinking Froot Loops contained real fruit.

“[Plaintiff] was misled by the packaging and marketing, which by design and intent convey the message that the Product contains real, nutritious fruit," alleges Werbel about a product named "Froot Loops."  The complaint continues, "[h]ad he known that 'Froot Loops' contained no fruit, he would not have purchased it."  This, of course, is pleaded as a class action, and Werbel alleges that the manufacturer's practices with regard to Froot Loops "present a threat to members of the general public . . . ."  Oh, the humanity.

By my count, these are the sixth and seventh lawsuits in California against the manufacturers of these two fictitiously named cereals.  But hey - just because you are 0-5 and your arguments have been openly mocked by judges as well as a large percentage of the nation's bloggers does not mean you shouldn't give it one or two more tries. It does mean that, presumably, PepsiCo and Kellogg's are highly unlikely to settle, and that in two or three months plaintiffs should be 0-7.

Kevin Underhill swiped at earlier plaintiffs, who alleged they were led to believe that "Crunch Berries" and/or "Froot Loops" are made with real fruit, “I still think this is like claiming emotional distress because you just learned "The Hobbit" isn't a true story.”

In light of this case, SF Weekly has issued a “corporate caveat noting that, while our offices are located at 185 Berry Street, our publication should in no way be considered a nutritious source of fruit.”

Defect Action Levels (The Maggots in Your Mushrooms)

It is economically impractical to produce food that is completely free of all naturally occurring defects. Non-hazardous defects that are unavoidable by good manufacturing practices are subject to tolerances, which the Food and Drug Administration (FDA) lists as “Defect Action Levels.” 

E. J. Levy had an interesting op-ed piece recently on this topic: 

You may be grossed out, but insects and mold in our food are not new. The F.D.A. actually condones a certain percentage of “natural contaminants” in our food supply — meaning, among other things, bugs, mold, rodent hairs and maggots.

In its (falsely) reassuringly subtitled booklet “The Food Defect Action Levels: Levels of Natural or Unavoidable Defects in Foods That Present No Health Hazards for Humans,” the F.D.A.’s Center for Food Safety and Applied Nutrition establishes acceptable levels of such “defects” for a range of foods products, from allspice to peanut butter.

Among the booklet’s list of allowable defects are “insect filth,” “rodent filth” (both hair and excreta pellets), “mold,” “insects,” “mammalian excreta,” “rot,” “insects and larvae” (which is to say, maggots), “insects and mites,” “insects and insect eggs,” “drosophila fly,” “sand and grit,” “parasites,” “mildew” and “foreign matter” (which includes “objectionable” items like “sticks, stones, burlap bagging, cigarette butts, etc.”).

Tomato juice, for example, may average “10 or more fly eggs per 100 grams [the equivalent of a small juice glass] or five or more fly eggs and one or more maggots.” Tomato paste and other pizza sauces are allowed a denser infestation — 30 or more fly eggs per 100 grams or 15 or more fly eggs and one or more maggots per 100 grams. . . .

E. J. Levy, The Maggots in Your Mushrooms, New York Times (Feb. 12, 2009).

For more fun and to amaze and gross out your friends:  FDA’s  Defect Levels Handbook: The Food Defect Action Levels — Levels of natural or unavoidable defects in foods that present no health hazards for humans.

Bon appétit!

Greg Jaffe Seminar on Genetically Engineered Food Oct 20 at Michigan State University

Larry King Blows It On Unsafe Meat

Marion Nestle’s comments about Larry King’s show on meat safety, Larry Kings Blows It On Unsafe Meat, is available in TheAlantic.com.  A clip from the show, of Bill Marler’s reaction to Larry King butchering the term, “E. coli” appeared on David Letterman Show right near the end of the monologue (three minutes in).

More Soda Tax News

The Food Law Prof Blog, Soda Tax in the News, has a compilation of articles on proposed taxes on sugar sodas:

• Food Law Prof Blog on President Obama's thoughts. 

• "A recent study by a star-studded cast of nutrition and obesity experts published in the New England Journal of Medicine this week is stirring things up. :The Public Health and Economic Benefits of Taxing Sugar-Sweetened Beverages, (by Kelly D. Brownell, Ph.D., Thomas Farley, M.D., M.P.H., Walter C. Willett, M.D., Dr.P.H., Barry M. Popkin, Ph.D., Frank J. Chaloupka, Ph.D., Joseph W. Thompson, M.D., M.P.H., and David S. Ludwig, M.D., Ph.D.)"

• New York Times, Sept. 16, 2009: Proposed Tax on Sugary Beverages Debated

• ABCNews.go.com, Sept. 16, 2009: Public Health Leaders Propose Soda Tax 

The Precautionary Principle Is Not The Answer

“Better safe than sorry,” is a well known aphorism because it contains a lot of sense. The precautionary principle allures us with words that sound similar to common-sense precaution. 

Unfortunately, the principle is a both a shape shifter and a chameleon. The term can shift in meaning to support whatever side one wishes to take on an issue. Worse, the principle appears to—but does not—provide us guidance in dealing with uncertain risk. The principle appears effective only because it compares uncertain risk against implicit zero risk for the status quo. 

In the real world, difficult questions of uncertain risk are problems of benefits versus risks, risks versus risks, and benefits and risks versus alternative benefits and risks. The principle is at its worst in guiding us with risk versus risk situations. The precautionary principle advises us to avoid both risks—but how do both take action and inaction at the same time? Or as Michael Crichton said, “The precautionary principle properly applied forbids the precautionary principle. It is self-contradictory.”

Ronald L. Doering has written a pithy essay, “The Precautionary Principle Is Not The Answer,” that uses excellent examples to illustrate the fundamental flaw with the using the precautionary principle as an approach to deal with risk versus risk:

If the hazard of DDT, for example, were a possible threat to the environment, then the application of the precautionary principle would be to ban the product until the science is clearer. If the hazard is malaria causing mosquitoes and the million persons killed (and the 300 million made seriously ill) by malaria each year then wouldn’t the principle support taking action to continue to use the product until the science is more certain? A principle that is this malleable cannot be a reliable guide to decision making, but it is still often used as a justification for a decision taken for other reasons.

Or consider the fortification of enriched flour with folic acid. The risk of neural tube defects (major birth defects of the brain and spine, such as spina bifida) can be reduced by 50-70 percent if women receive folic acid supplementation starting three months before becoming pregnant. An estimated 1,000 more babies are born healthy each year because of mandatory fortification of foods with folic acid in the US. 
On the other hand, there are unknown risks of folate fortification for the majority of consumers who receive no benefit from increased folate. A recent study showed there might be a link between high intakes of folic acid and possible increased risk for colon cancer.
The precautionary principle supports mandatory fortification with folate. Rather than take the risk of inaction while the science is uncertain about the risks of fortification, it is better to be safe and prevent a thousand newborns a year from major birth defects. Accordingly, the US in 1994 and Canada in 1998 mandated fortification of certain flours and breads. “Applying the same principle, Britain and Ireland declined to require mandatory fortification.”

FTC's Revised Guides Governing Endorsements, Testimonials

The Federal Trade Commission (FTC) revised its guidance to advertisers on how to keep their endorsement and testimonial ads in line with the FTC Act.  Changes to the FTC’s Guides Concerning the Use of Endorsements and Testimonials in Advertising address endorsements that feature a consumer and convey his or her experience with a product or service as typical when that is not the case will be required to clearly disclose the results that consumers can generally expect.  Advertisers no longer can consider a disclaimer, such as “results not typical,” to be a safe harbor.

More information is available here.  The text of the Federal Register Notice is here.

GMA's 2010 Food Claims and Litigation Conference - Feb. 23-25 - Austin, TX

The Grocery Manufacturers Association's 2010 Food Claims and Litigation Conference is scheduled to take place February 23-25, and will be held at Barton Creek in Austin, Texas.  Nationally recognized authorities from the food, legal, and scientific communities will present up-to-the-minute information on:

-Recent Developments in Product Liability

-Emerging Trends in Foodborne Illness Litigation

-Micro-Contaminants in Food: Emerging Legislative, Regulatory and Litigation Trends

-A Thirty-Year Retrospective on Trial Sciences

-Food Allergens: Understanding the Science and Avoiding the Pitfalls

-Mass Tort 911: The Company's Been Sued! Now What?

-What Every Food Industry Defense Lawyer Needs to Know About Bankruptcy

-Recent Preemption Rulings May Be Opening the Floodgates of State Law Consumer Fraud in Labeling Class Litigation

-The Recall Playbook: Offense and Defense

-Flavoring Litigation: Current Status and Latest Regulations And Their Effect on Future Litigation

-Trends in Global Food Litigation:  Class Actions and Collective Redress

More information is available here.

It is Time for the Food Safety Enhancement Act

H.R. 2749 passed in the House of Representatives. Now is the time for the Senate to vote.

Bill Marler predicted that food safety legislation would pass Congress by Thanksgiving and be signed by the President before Christmas. Predicting the movement of Congress is difficult. Sometimes only a shocking event can prod Congress to action. Tainted cookie dough may have been the last straw for the House passage of H.R. 2749.

Senators, what are you waiting for?

The Congressional Research Service (CRS) a nonpartisan arm of the Library of Congress prepared the following summary of H.R. 2749:

As of 6/8/2009--Introduced. Food Safety Enhancement Act of 2009 - 

 ·    Amends the Federal Food, Drug, and Cosmetic Act to set forth provisions governing food safety.

 ·    Requires each food facility to: (1) conduct a hazard analysis; (2) implement preventive controls; and (3) implement a food safety plan.

 ·    Requires the Secretary of Health and Human Services to: (1) issue science-based performance standards to minimize the hazards from foodborne contaminants; (2) establish science-based standards for raw agricultural commodities; (3) inspect facilities at a frequency determined pursuant to a risk-based schedule; (4) establish a food tracing system; (5) assess fees relating to food facility reinspection and food recall; and (6) establish a program for accreditation of laboratories that perform analytical testing of food for import or export.

 ·    Authorizes the Secretary to: (1) order an immediate cessation of distribution, or a recall, of food; (2) establish an importer verification program; and (3) quarantine food in any geographic area within the United States.

 ·    Defines the term "color additive" to include carbon monoxide that may affect the color of fresh meat, poultry products, or seafood.

 ·    Requires country of origin labeling on food and annual registration of importers.

 ·    Provides for unique identifiers for food facilities and food importers.

 ·    Deems a food to be adulterated if an inspection is delayed or refused.

 ·    Requires the Secretary to establish a corps of inspectors dedicated to inspections of foreign food facilities.

 ·    Sets forth provisions governing the reorganization of Food and Drug Administration (FDA) field laboratories and district offices.

 ·    Gives the Commissioner of Food and Drugs subpoena authority with respect to a food proceeding.

 ·    Establishes whistleblower protections.

For further thoughts:

•      Bill Marler’s summary
•      New York Times Editorial, Vote for Safer Food 
•            Hearings of the Subcommittee on Health

Dannon Settles False Ad Suit for $35 Million

Noreen O'Leary reports that the law firm, Coughlin, Stoia, Geller, Rudman & Robbins, secured a $35 million settlement with Dannon over allegedly misleading ads and labeling of  Activia and DanActive yogurt products. Under the stipulation of settlement, Dannon also agreed to change the way it markets and labels these products.

Now CSGR&R is pursuing a similar complaint against General Mills and its Yoplait Yo-Plus yogurt. The complaint against Yo-Plus alleges, "General Mills has no support for these claims, even though it states that it does, going so far as to claim it has clinical proof. General Mills' representations are false, misleading and reasonably likely to deceive the public."

A rep for General Mills, which began to market Yo-Plus in August 2007, said: "As a standing practice, we don't comment on pending litigation."

Noreen O’Leary also wrote, “Junk Science: 'Functional' foods promise good health -- but can they deliver?"

That Model of Poor Legal Drafting

My morning distraction was reading the Hatch-Waxman 25^th Anniversary Trivia by Kurt Karst. My favorite part is the exchange between Judge Roger W. Titus, U.S. District Court for the District of Maryland, and Gerald C. Kell from the Department of Justice (December 21, 2006) in Biovail Corporation. v. FDA:

THE COURT:  [After asking detailed questions about the Federal Food, Drug, and Cosmetic Act.]  All right.  There’s a special place in Hell where they torture people who write things like this.  For 14 years I was on the Rules Committee of Maryland’s Court of Appeals that didn’t have as many subsections as this, so I would flunk the person who gave me this as a draft rule.  I would say this is 50 rules.

Anyway, I wanted to wander into the right place of this endless section.  When I first went to Westlaw and said, just give me section 355, it had to tell me it was going to be 85 pages.  I said, no, no, no, no.  Let’s try (j), and I get this huge thing here.

ATTORNEY:  Well I hope that our brief lays out the precise subsections, Your Honor.  I believe it does.  But that is the sum of my argument, unless the court has any further questions.

THE COURT:  No.  You’ve been very helpful.  I’m glad to have somebody here who knows what they’re talking about.

ATTORNEY:  So am I, Your Honor.  It’s just not me.  Thank you.

THE COURT:  Thank you.  

To protect the public and to put a trial lawyer out of business

A clever blog post by Bill Marler, "New Food Safety Legislation is needed - to protect the public and to put a trial lawyer out of business."

USDA Reopens Comments on Use of "Natural"

The U.S. Dept. of Agriculture’s (USDA) Food Safety and Inspection Service (FSIS) has issued an Advance Notice of Proposed Rulemaking (ANPRM) to seek additional comments from the public on the conditions under which FSIS should permit the claim “natural” in the labeling of meat and poultry products. After considering the more than 12,000 comments on “natural” submitted in response to a Federal Register notice that the Agency issued on Dec. 5, 2006, and the comments presented at a public meeting held by the FSIS on Dec. 12, 2006, FSIS has decided to solicit additional public input.

FSIS is soliciting further comments on numerous issues. More information is available in 74 Federal Register 46951-46957 (Sept. 14, 2009). Comments are due by Nov. 13, 2009.

Additional reading: Ricardo Carvajal, FSIS Has Second Thoughts On Issuing a Proposed Rule to Define “Natural”.

Fish Detective Busts Restaurant Switcharoos

The NPR Health Blog’s Scott Hensley has an interesting short piece concerning economic adulteration. Restaurants sometimes substitute cheaper fish for more expensive species, like grouper and red snapper. You can read the blog post here. Particularly interesting are the precocious New York high school students who used genetic testing to detect adulteration in the Big Apple’s restaurants and markets. Half the restaurants and six of ten grocery stores had mislabeled fish.

Hungry for Change

Kristin Choo, wrote a nice article, “Hungry for Change: The feds consider a steady diet of stronger regulation to help fix the U.S. food safety network, for the September 2009 Issue of ABA Journal. She did a fine job summarizing a complex subject. You can read the article here.

FDA USDA Letter to the Smart Choices Program

Advising the Smart Choice program that the agencies will be scrutinizing their front-of-the-pack nutrition label, the August 19 letter noted that consumer research indicates people are less likely to check the Nutrition Facts label on the back or side panel of foods with front-of-pack labeling. Therefore, “it is essential that both the criteria and symbols used in front of package and shelf-labeling systems help consumers make healthy food choices.”

These labels and symbols have proliferated in recent years. FDA and USDA noted that they will, “monitor and evaluate the products as they appear and their effect on consumers' food choices and perceptions.FDA and FSIS would be concerned if any FOP labeling systems used criteria that were not stringent enough to protect consumers against misleading claims; were inconsistent with the Dietary Guidelines for Americans; or had the effect of encouraging consumers to choose highly processed foods and refined grains instead of fruits, vegetables, and whole grains.”

FDA announces comment period on Internet survey on barriers to food label use

In 74 Fed. Reg. 42676 (Aug. 24, 2009), the Food and Drug Administration (FDA) has announced an opportunity for public comment on a proposed voluntary Internet survey to assess barriers to food label use by consumers. Analyses or previous surveys have shown a sharp decline in food label use between 1994 and 2002, especially among consumers younger than 35 years old. The purpose of this survey is to learn the reasons for this decline in label usage. “The study goals are to: (1) identify attitudes and beliefs among consumers toward health, diet and label usage; (2) determine relationships between those attitudes and beliefs, as well as demographics, with food label use and non-use; and (3) evaluate the relative importance of these attitudes between consumers of various age groups to determine whether barriers to label use differ between younger consumers and older consumers.” Comments on the proposed information collection should be submitted by October 23, 2009.

Don't Eat That! Legal Issues in Food Safety

On Wednesday, September 16, 2009, a 60-Minute ABA Teleconference will held from 1:00 to 2:00 PM (eastern time), “Don't Eat That! Legal Issues in Food Safety.” The program description reads:

It seems that hardly a month goes by without a story about American food shoppers falling prey to another nasty pathogen lurking in the local supermarket. Several well-publicized outbreaks of food-related illness have created a rare political alignment. Angry consumers and a food industry haunted by the double specter of bad publicity and lawsuits both appear ready to embrace actions by the federal government to make the U.S. food supply safer, and the federal government has begun to take some of those steps.

In March, President Barack Obama announced the formation of a Food Safety Working Group to develop proposals for upgrading federal food safety laws and improving coordination among at least a dozen federal entities that share responsibility for the safety of the nation’s food supply. Some of the working group’s recommendations already are being put into effect.

Meanwhile, legislation has been introduced in Congress that would dramatically increase the oversight power of the Food and Drug Administration over much of the food sold in the United States, including imports. It appears certain that the legal framework for regulating food safety in the United States is going to change, and lawyers—especially those who represent companies in the food industry—are going to have to hustle to keep up.

What sorts of changes are likely and how effective they will be is currently being debated. While some see a consensus around the need for sweeping reform, others are concerned that proposals in the works are over-broad and will be detrimental to organic farmers and small producers among others.

Join our distinguished group of experts as they discuss the current situation of food safety law changes.

The Panelists are:

Neal D. Fortin, Director, Institute for Food Laws and Regulation, Michigan State University, East Lansing, MI

James T. O'Reilly, Professor, University of Cincinnati, Chair, FDA Committee, American Bar Association Section of Administrative Law and Regulatory Practice, Cincinnati, OH

Stuart M. Pape, Managing Partner, Patton Boggs LLP, Washington, DC

Register by phone at: 800.285.2221 or online at: http://www.abanet.org/cle/connection.html.

FDA Guidance on Labeling of Certain Beer Products

The Food and Drug Administration (FDA) issued draft guidance on the labeling of non-malt This blog discussed some of the issues involved in When Beer is not Beer. Beer-like products without malted barley or that are made without hops, fall under FDA rather than the Alcohol and Tobacco Tax and Trade Bureau (TTB). The guidance advises the industry on how to label "beers" that are subject to the FDA's labeling requirements under the Federal Food, Drug, and Cosmetic Act and the Fair Packaging and Labeling Act.

FDA's new draft guidance, "Labeling of Certain Beers Subject to the Labeling Jurisdiction of the Food and Drug Administration," specifies the mandatory information required on the labels of these non-malt beers. Manufacturers of non-malt beers are expected to comply with the FDA's labeling requirements by Jan. 1, 2012. The Federal Register notice (74 FR 41438) can be viewed on the GPO Access web site and the guidance can be viewed on the FDA website.

Weasel Words (AKA Disclaimer)

One humorous disclaimer I saw on a legal blog:

“this is not legal advice, this is a general information blog post on the internet. (And if it's on the internet, it's gotta be true, right? Uh ... no.) If you haven't paid me a retainer, you are not (yet) my client and should not rely on any of this information to make any decisions. The law is complicated. The facts even more so. If I could have learned the law by reading blogs, I'd ask for money back from those three plus years of hell I paid for in law school.”

You can catch F. Bennett Callicoat’s blog and disclaimers at the Tulsa Bankruptcy and Consumer Law blog.

Raw Milk Legal Implications

Bill Marler recently gave a short overview of the legal implications of raw milk. A copy of slides is available here as well additional materials on the topic. Hat tip to Bill Marler for this service.

How to Prepare for an FDA Inspection and Recall

Jim Prevor, the Perishable Pundit, recently posted a valuable article on dealing with recalls and FDA. No company wants to be involved in a recall so prevention is the first strategy, but every company should think through how they would perform in a recall. In particular, how would the firm handle the intense regulatory and media scrutiny. Smart companies will be prepared with a contingency plan. Jim’s article provides a nice sketch of the basic steps involved in putting together such a plan. The full article is available here.

FDA Serious About Food Allergen GMPs

Ricardo Carvajal calls our attention to FDA’s seriousness about food allergen GMPs, “the government is asking a federal district court to enjoin certain manufacturers of protein powder mixes and dietary supplements from further marketing of products alleged to be adulterated under FDC Act section 402(a)(4) due to the manufacturers’ failure to minimize cross-contact with a major food allergen. The complaint makes clear that FDA interprets section 402(a)(4) and 21 C.F.R. Part 110 to require manufacturers to take “all reasonable precautions. . . to ensure that production procedures do not contribute to contamination from any source, including food allergens.”

Hat tip to Ricardo Carvajal for another great blog.

Wal-Mart's Environmental Labeling Changes the Game

Wal-Mart is planning a new environmental labeling requirement for its suppliers. The future label information may provide the product’s carbon footprint, the gallons of water used to create it, and the air pollution left in its wake. Rosabeth Moss Kanter, professor at the Harvard Business School wrote,

Wal-Mart's unilateral decision to put its purchasing and communication power behind going green also shows that a single company using its unique clout can accelerate public action to reduce greenhouse gases and reverse climate change. By rolling out an environmental labelling program disclosing to consumers the environmental costs of making products sold at Wal-Mart, the $401 billion retail behemoth has transformed green standards from nice-to-have to must-have.

The beauty of the Wal-Mart innovation is that it doesn't ask anyone to change anything except the information that is provided and received. If polluters want to keep polluting, they are free to do so as long as they provide that data on their Wal-Mart labels. And if consumers choose to buy from polluters whose labels they can read, they are free to do so. In theory. In practice, of course, we know that suppliers will change their practices to avoid embarrassing disclosures.

Read Rosabeth Moss Kanter whole article, Wal-Mart's Environmental Game-Changer, here.

Kanter is the author of SuperCorp: How Vanguard Companies Create Innovation, Profits, Growth, and Social Good.

Dave Theno had it right - Bill Marler Guest Blog

Secretaries Vilsack and Sebelius should pay attention

Lauren Beth Rudolph died on December 28, 1992 in her mother’s arms due to complications of an E. coli O157:H7 infection - Hemolytic Uremic Syndrome. She was only 6 years, 10 months, and 10 days old when she died. Her death, the deaths of three other children, and the sicknesses of 600 others, were eventually linked to E. coli O157:H7 tainted hamburger produced by Von’s and served at Jack in the Box restaurants on the West Coast during late 1992 and January 1993. Roni Rudolph, Lauren’s mom, I have known for 16 years.

Dave Theno became head of Jack in the Box’s food safety shortly after the outbreak. I too have known Dave for 16 years. However, I only learned recently a significant fact about Dave – one that made me admire him even more – one that I think, not only that all leaders in corporate food safety should emulate, but one that both Secretaries Vilsack and Sebelius should pay attention too.

Dave and I shared the stage at the Nation Meat Association annual convention a few months ago. The NMA is an association representing meat processors, suppliers, and exporters. Dave, spoke just before I did and was rightly lauded as someone who takes food safety to heart. However, it was his story about Lauren Rudolph and his relationship with Roni that struck me. Dave told the quiet audience about Lauren’s death. Dave also told us that the death of Lauren and his friendship with Roni had changed him. He told us all that he had carried a picture of Lauren in his brief case everyday since he had taken the job at Jack in the Box. He told us that every time he needed to make a food safety decision – who to pick as a supplier, what certain specifications should be – he took out Lauren’s picture and asked, “What would Lauren want me to do?”

I thought how powerful that image was. The thought of a senior executive holding the picture of a dead child seeking guidance to avoid the next possible illness or death is stunning, but completely appropriate. I wonder if Secretaries Vilsack and Sebelius do anything similar when they do their work on President Obama’s Food Safety Working Group? If they do not, perhaps they should?

Secretaries Vilsack and Sebelius right now there are hundreds of families struggling right now due to illnesses and death related to food that you oversee that has been tainted with E. coli O157:H7.

Yesterday, I spent time with a family in South Carolina whose 4 year old ate cookie dough and suffered months of hospitalizations, weeks of dialysis and seizures. She faces a lifetime of complications. And, there is a woman in Nevada who is still hospitalized, who has lost a portion of her large intestine, was on dialysis until a few days ago. She faces months if not years of rehabilitation. Both ate cookie dough that was watch over by Secretary Sebelius’s FDA.

Today I sat across the kitchen table with a family who lost their only daughter because she died from an E. coli O157:H7 infection from meat inspected by Secretary Vilsack’s USDA/FSIS. I then visited families in a Cleveland hospital whose children are struggling in their battle against Hemolytic Uremic Syndrome – again E. coli O157:H7 tainted hamburger is to blame.

Secretaries Vilsack and Sebelius you should be like Dave Theno. Run your departments like Dave ran food safety at Jack in the Box. Go meet these families. Sit across their kitchen tables. Go to their child’s hospital room and see more tubes and wires than you can count. Understand what these people have lived though. Take their stories into your heart. It is hard, very hard, but it will give you a real reason to do your jobs.

William D. Marler, Esq.
Marler Clark LLP PS
6600 Columbia Center
701 Fifth Avenue
Seattle, Washington 98104
P: 1-206-346-1890
F: 1-206-346-1898
C: 1-206-794-5043
E: bmarler@marlerclark.com
W: www.marlerclark.com
B: www.marlerblog.com

Team Diarrhea to the Rescue!

Minnesota Senator Amy Klobuchar introduced the Food Safety Rapid Response Act of 2009, S 1269. The bill is intended to enhance foodborne illness surveillance and improve food safety by through more rapid and coordinated response to foodborne disease outbreaks. The bill would direct the Centers for Disease Control (CDC) to promote best practices for foodborne illness surveillance and improve the surveillance capacities of the states.

Like the Emperor’s New Clothes, no one wants to talk about the lack of capacity at many state and local health departments. However, this is not just a state and local issue. Our federal food safety system stands (or falls) on the shoulders of the ability and capacity of the states.

Contrast a few states, like Minnesota, known for fine foodborne disease surveillance. Minnesota has a group of investigators, known as Team Diarrhea, that race into action when there is a suspected foodborne disease outbreak. Minnesota was the first to trace the source of the recent Salmonella disease outbreak to peanut butter from Georgia. Essentially, our federal food safety system depended on people in Minnesota getting sick or dying to detect a national food safety problem that started in Georgia?

S 1269 would help create a more rapid and coordinated response to foodborne illness outbreaks. The bill could possibly lead to the institution of Team Diarrhea nationally.

Senator Klobuchar’s press release.

Hat tip to Cynthia Dizikes in MinnPost.com.

Public Workshops on the FDA Reportable Food Registry

FDA announced three public workshops on the Reportable Food Registry. The public workshops are to explain the purpose of the Registry, how it will work, and the responsibilities of persons required to submit a report regarding instances of reportable food to FDA through the Reportable Food electronic portal. In addition, the role of federal, state and local public health officials in voluntarily reporting instances of reportable food to FDA will be discussed.

Electronic registration is encouraged. Please go to Reportable Food Registry Public Workshops for more information.

On September 27, 2007, the Food and Drug Administration Amendments Act of 2007 (FDAAA) amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) by creating a new section referred to as 417, Reportable Food Registry. Section 417 requires the Secretary of Health and Human Services to establish within the Food and Drug Administration (FDA) a Reportable Food Registry. The congressionally-identified purpose of the Reportable Food Registry is to provide a "reliable mechanism to track patterns of adulteration in food [which] would support efforts by the Food and Drug Administration to target limited inspection resources to protect the public health" (Pub. L. 110-085, § 1005(a)(4)).

The Secretary has delegated to the Commissioner of FDA the responsibility for administering FD&C Act section 417. To further the development of the Reportable Food Registry, section 417 requires FDA to establish an electronic portal by which instances of reportable food must be submitted to FDA by responsible parties and may be submitted by public health officials. A "reportable food" is an article of food (other than infant formula) for which there is a reasonable probability that the use of, or exposure to, such article of food will cause serious adverse health consequences or death to humans or animals.

(FD&C Act § 417(a)(2)). "Responsible party" is defined as the person who submits the registration information to FDA for a food facility that manufactures, processes, packs, or holds food/feed for human or animal consumption in the U.S.

The Registry is scheduled for implementation on September 8, 2009, and applies to all FDA-regulated categories of foods except dietary supplements and infant formula. FDA has published draft Guidance for Industry: Questions and Answers Regarding the Reportable Food Registry as Established by the Food and Drug Administration Amendments Act of 2007 (June 2009). This guidance contains questions and answers relating to the requirements under section 417 of the FD&C Act, including (1) how, when and where to submit reports to FDA; (2) who is required to submit reports to FDA; (3) what is required to be submitted to FDA; and (4) what may be required when providing notifications to other persons in the supply chain of an article of food.

Comical Case Names

Drunkenness image via Wikipedia

From Lowering the Bar. Legal Humor. Seriously, by Kevin Underhill:

United States v. 11 1/4 Dozen Packages of Articles Labeled in Part Mrs. Moffat’s Shoo-Fly Powders for Drunkenness, 40 F. Supp. 208 (W D.N.Y. 1941) (holding product was misbranded because it was not in fact a cure or treatment for drunkenness).

Julius Goldman's Egg City v. United States, 464 U.S. 814 (1983).

United States v. Approximately 64,695 Pounds of Shark Fins, No. 05-56274 (9th Cir. Mar. 17, 2008).

A Scary Reminder that Restaurant Allergen Negligence Can be Fatal

I sat up half the night with an Epi-pen watching my wife to see if she was still breathing. The restaurant we ate at that night contaminated my wife’s meal with tree nuts. Although we had told the server that my wife was allergic to nuts -- and the server assured us there would be no nuts -- someone or some system failed at the restaurant.

The restaurant, Gulfstream, an upscale eatery in Orange Country, California, looked beautiful. Everyone at the restaurant presented a polite façade, but ultimately seemed unconcerned about their negligence, which could have killed one of their patrons. The restaurant management has not answered or returned my phone calls.

The Orange Country HCA Environmental Health agency was perhaps worse. The agency would not take my complaint on food contaminated with hidden allergens. The HCA person acknowledged the agency inspected the restaurant, but she thought allergens were solely the consumers’ responsibility. Moreover, the health agency employee seemed unaware that allergic reactions could be serious or even fatal. She dismissed my complaint as not their concern.

Someone ought to instruct Orange County government about the contents of the FDA Food Code, which is adopted by the state of California. We clearly have a ways to go on educating food service managers and health inspectors about food safety.

FSIS and FDA to Host a Public Meeting on Listeria Risk Assessment

FSIS and FDA to host a public meeting to discuss the interagency retail Listeria monocytogenes risk assessment on June 23 in Washington, DC, to discuss the background, approach and scope of a new interagency risk assessment.

Today's Hearing on the Draft Food Safety Enhancement Act of 2009

Documents and video from today's Energy & Commerce Subcommittee on Health hearing on “Food Safety Enhancement Act of 2009” are available here.

Stalemate at the USDA

Tom Laskawy at the Beyond Green blog has an interest post on the reasons why Vilsack “can't find anyone to run the USDA's Food Safety and Inspection Service. You wouldn't think it would be that hard. There must be dozens of scientists and food safety experts who fit the bill.”  . . . “The three candidates mentioned for the post so far, Michael Osterholm, Michael Taylor (though it's unclear if he was really up for the job) and Mike Doyle (so many Mikes!) are all champions of what Marion Nestle likes to call "late-stage techno-fixes." Or, as Obamafoodorama puts it, ‘Zap the crap!’" . . .

The President's Food Safety Working Group has a “spanking new website, [but] the administration hasn't released the names of anyone who's serving on it. The administration's food safety stalemate applies over there as well.”

Read the whole article here.

Search Warrants-What Happens When the FDA Storm Arrives

FDA’s use of criminal search warrants is increasing according to John R. Fleder in his recent article in Update, “Search Warrants—What Happens When the FDA Storm Arrives.” The article offers precautionary steps to ensure a business is prepared to deal with the possibility of a FDA search.

Summary of Discussion Draft of the Food Safety Enhancement Act of 2009

Representatives John D. Dingell, Henry A. Waxman, Frank Pallone, Bart Stupak, Diana DeGette, and Betty Sutton released a discussion draft of the Food Safety Enhancement Act of 2009. The draft is largely based on the food provisions of H.R. 759, the Food and Drug Administration Globalization Act of 2009, introduced in January by Reps. Dingell, Stupak, and Pallone. The Food Safety Enhancement Act of 2009 incorporates technical assistance from the new Administration as well as other stakeholders. The legislation grants the Food and Drug Administration (FDA) the authorities and resources it needs to better ensure the safety of the nation's food supply. The Committee has scheduled a legislative hearing for June 3, 2009.

From the Summary of Discussion Draft of the Food Safety Enhancement Act of 2009:

Food Safety

1. Creates an up-to-date registry of all food facilities serving American consumers: Requires all facilities operating within the U.S. or importing food to the U.S. to register with the FDA annually.

2. Generates resources to support FDA oversight of food safety: Requires registered facilities to pay an annual registration fee of $1,000 in order to generate revenue for food safety activities at the FDA; requires registered facilities to pay for FDA’s costs associated with reinspections and food recalls; allows FDA to charge a fee to domestic firms requesting export certificates for exported food.

3. Prevents food safety problems before they occur: Requires all facilities operating within the U.S. or importing food to the U.S. to implement safety plans that identify and protect against food hazards. FDA would have the authority to specify minimum food safety plan requirements and to audit food safety plans.

4. Requires safety plans for fresh produce: Directs FDA to issue regulations for ensuring the safe production and harvesting of fruits and vegetables.

5. Increases inspections of food facilities: Sets a minimum inspection frequency for all registered facilities. High-risk facilities would be inspected at least once every six to 18 months; low risk facilities would be inspected at least once every 18 months to three years; and warehouses that store food would be inspected at least once every three to four years. Refusing, impeding, or delaying an inspection is prohibited.

6. Improves traceability of food: Enhances FDA’s ability to trace the origin of tainted food in the event of an outbreak of foodborne illness. FDA would be required to issue regulations that require food producers, manufacturers, processors, transporters, or holders to maintain the full pedigree of the origin and previous distribution history of the food and to link that history with the subsequent distribution history of the food; and to establish an interoperable record to ensure fast and efficient traceback (current law permits facilities to hold a record in any format — paper or electronic — making efficient tracing of foods difficult for FDA). Prior to issuing such regulations, FDA would be required to conduct a feasibility study, public meetings, and a pilot project.

7. Enhances the safety of imported food: As an additional layer of protection, FDA can require food to be certified as meeting all U.S. food safety requirements by the government of the country from which the article originated or by certain qualified third parties. Third party certifying entities must meet strict requirements to protect against conflicts of interest with the firm seeking certification.

8. Expands laboratory testing capacity: Requires FDA to establish a program to recognize laboratory accreditation bodies and to accept test results only from duly accredited laboratories. Gives FDA the ability to require laboratories to send test results to FDA.

9. Provides strong, flexible enforcement tools: Provides FDA new authority to issue mandatory recalls of tainted foods. Strengthens criminal penalties and establishes civil monetary penalties that FDA may impose on food facilities that fail to comply with safety requirements.

10. Creates fast-track import process for food meeting security standards: Permits FDA to develop voluntary security guidelines for imported foods. Importers meeting the guidelines would receive expedited processing.

11. Enhances the safety of infant formula: Enhances FDA’s ability to assure the safety of new infant formulas before they go on the market.

12. Advances the science of food safety: Directs the Secretary to include food in an active surveillance system to assess more accurately the frequency and sources of human illness. The Secretary is also directed to identify industry and regulatory approaches to minimize hazards in the food supply.

13. Enhances FDA’s ability to block unsafe food from entering the food supply: Strengthens FDA’s authority to administratively detain unsafe food products. Grants FDA “quarantine” authority under which the agency may restrict or prohibit the movement of unsafe food products from a particular geographic area.

14. Directs FDA to assess the use of carbon monoxide in certain foods: Requires FDA to conduct a safety review of the use of carbon monoxide in meat, poultry, and seafood products.

15. Enhances transparency of GRAS program: Requires posting on FDA’s website of documentation submitted to FDA in support of a “generally recognized as safe” (GRAS) notification.

16. Requires country-of-origin labeling and disclosure: Requires all processed food labels to indicate the country in which final processing occurred. Requires food manufacturers to identify the country of origin for all ingredients on their websites. Requires country-of-origin labeling for all produce.

 

General Provisions

1. Creates an up-to-date registry of importers: Requires all importers of drugs, devices, and foods to register with the FDA annually and to pay a registration fee.

2. Requires unique identification numbers for facilities and importers: To enhance information about FDA-regulated entities, creates unique identification numbers for all drug, device, and food facilities and importers.

3. Creates a dedicated foreign inspectorate: Requires FDA to establish and maintain a corps of inspectors to monitor foreign facilities producing food, drugs, devices, and cosmetics for American consumers.

4. Grants FDA new authority to subpoena records related to possible violations.

5. Provides protection for whistleblowers that bring attention to important safety information: Prohibits entities regulated by the FDA from discriminating against an employee in retaliation for assisting in any investigation regarding any conduct which the employee reasonably believes constitutes a violation of federal law.

IFT Annual Meeting & Food Expo

The Institute for Food Laws & Regulations (IFLR) will be at the IFT Annual Meeting & Food Expo June 6-9. Stop by and see us at booth #602.

Thousands of food industry professionals from around the globe convene at IFT to learn about the latest developments in scientific research, technologies, new products, food law, and consumer trends. The IFT Annual Meeting & Food Expo brings together decision-makers from all of the many disciplines involved in food science, technology, law, and more. The meeting packs in tremendous educational sessions as well as offering great networking for professionals in R&D and other scientific/technical positions, as well as in corporate management, purchasing, consulting, academia, government/regulatory, and technical sales and marketing.

Hope to see you in Anaheim!

Seminar on Food Import Safety May 26-27

Neal Fortin will be speaking on food import law on May 27 in Madison, Wisconsin. The seminar titled, Food Import Safety: Systems, Infrastructure, and Governance, is sponsored by the Center for World Affairs and the Global Economy at University of Wisconsin – Madison. More information and the agenda are available here, here, and here.

To register, send an email to chpra@engr.wisc.edu with the following information: Name, Title, Affiliation, Mailing Address, Telephone Number, Fax Number, and E-mail. The conference is free-of-charge but space is limited. For a map of the UW campus, see http://www.map.wisc.edu/.