Saturday, February 21, 2009

Wednesday, February 18, 2009

Senates Wants Criminal Prosecution in Peanut Case

“At a panel discussion at the U on the rash of salmonella cases, the senator urged action against a peanut company executive and changes in U.S. food safety laws.

” U.S. Sen. Amy Klobuchar said Monday that the owner of a peanut-processing company should be prosecuted for the salmonella poisoning of more than 600 people and federal laws should be changed in the hope of preventing future outbreaks of food-borne disease.

"’Based on my review of the evidence, there should be a criminal prosecution here,’ said Klobuchar, D-Minn., after hosting a two-hour panel discussion on food safety at the University of Minnesota's St. Paul campus. . . .”

David Shaffer, Klobuchar: Prosecute peanut case, (Feb. 16, 2009) available at:

More for the Fructose Obesity Debate

In a paper in the Journal of Clinical Endocrinology and Metabolism, Karen L Teff and colleagues describe the outcome of an experiment in which they compared the effects of glucose-and fructose-sweetened beverages on hormones and metabolic substrates in 17 obese subjects (9 men and 8 women). Results indicated that, compared with the glucose-sweetened beverage, consumption of the fructose-sweetened beverage by the obese subjects, reduced insulin secretion, reduced the diurnal leptin profiles, and increased post-prandial triglyceride concentrations. Leptin is a hormone associated with reducing appetite. Compared with insulin-sensitive subjects, those with insulin resistance showed even greater increases in post-prandial triglycerides. Elevated blood triglycerides are risk markers not only for type 2 diabetes but also for cardiovascular disease. In summary the authors state that their results suggest “that fructose consumption may exacerbate an already adverse metabolic profile present in many obese subjects.”

Karen L. Teff et al., Endocrine and metabolic effects of consuming fructose- and glucose-sweetened beverages with meals in obese men and women: influence of insulin resistance on plasma triglyceride responses, Journal of Clinical Endocrinology & Metabolism (online Feb. 2, 2009) abstract available at: doi:10.1210/jc.2008-2192.

Thursday, February 12, 2009

Jorgen Schlundt on Food Safety Regulation

Jorgen Schlundt, the director of food safety, zoonoses and food-borne diseases at the World Health Organization, recently talked with NPR on what is needed in food safety inspection systems. Click here to listen to the 5 minute interview.

Arguments for Serving Facts Information on Alcoholic Beverages

Former Surgeon General Koop extols the virtues of serving facts for alcoholic beverages in reducing alcohol abuse and the many diseases attributable to excessive alcohol intake. 

The blog points out the effectiveness of this video. Dr. Koop is clearly a compelling speaker on this topic, but I think his effectiveness is more that he keeps it brief, succinct, hits the high points, and skips the nagging and whining.

I am putting on the next video only to demonstrate another approach to the debate.  This comment from the Drink Healthy, Drink Smart blog, “Maybe it’s just me, but I think this group needs to chill with a drink or two.”  After watching both, which do you think is more effective and why?

Monday, February 09, 2009

Truthful Statements Cannot Always Cure a False or Misleading One

In Williams v. Gerber, the Ninth Circuit recently reinstated a law suit against Gerber that alleged labeling on “fruit juice snacks” constituted misrepresentation and breach of warranty under California law. Gerber’s “Graduates for Toddlers Fruit Juice Snacks,” juxtaposed the product name with images of fruit (such as oranges, peaches, strawberries, and cherries) on the front of the package. However, the product contained none of those fruit juices, but only white grape juice from concentrate.

The product also stated that the Fruit Juice Snacks were made with “fruit juice and other all natural ingredients.” The court found that a reasonable consumer could interpret that to mean that all the ingredients were natural, which appeared to be false. The court also found that the label “claim that Snacks is ‘just one of a variety of nutritious Gerber Graduates foods and juices that have been specifically designed to help toddlers grow up strong and healthy’ adds to the potential deception.”

An important part of the defense in this case was that the product offered a full ingredient listing on the side panel, which cured any potentially misleading representations on the package। In abstract, this may seem reasonable. But here are the ingredients: “corn syrup, sugar, white grape juice from concentrate, contains less than 2% of the following: carrageenan, ascorbic acid (vitamin C), corn starch, natural flavors, citric acid, hydrogenated coconut oil, carnauba wax, red cabbage extract color, paprika color, beeswax, annatto color and elderberry juice concentrate color.” What do you think? Are these “Fruit Juice Snacks” or Fruit-flavored Candy”?

Basically, the court held that reasonable consumers should not be expected to look beyond misleading representations on the front of the box to discover the truth from the ingredient list in small print on the side of the box:

We do not think that the FDA requires an ingredient list so that manufacturers can mislead consumers and then rely on the ingredient list to correct those misinterpretations and provide a shield for liability for the deception. Instead, reasonable consumers expect that the ingredient list contains more detailed information about the product that confirms other representations on the packaging.

This decision follows the line of the classic “lollipop” case, “However, even though the actual ingredients are stated on the outside of a carton, false or misleading statements inside the carton may lead to the conclusion that the labeling is misleading, since a true statement will not necessarily cure or neutralize a false one contained in the label.” United States v. 432 Cartons Individually Wrapped Candy Lollipops, 292 F. Supp. 839 (1968). (Shameless plug: In chapter three of my book, Food Regulation: Law, Science, Policy, and Practice.)

Ken Odza in Food Liability Law Blog, When Is Labeling Misleading and Actionable Under State Law? Is There Any Clearly Understood Standard? found the Williams decision troubling:

As a practical matter, the only way manufacturers can mitigate against these types of putative class actions is to involve lawyers directly in the marketing and labeling process. Under the world imagined in the Williams case, legal training seems to be a prerequisite to understanding which labels may give rise to litigation and which may not.

Good advice, Ken, because lawyers should be on the product development team early on—before the marketing gurus get too far out. Labeling can be simple, but it can also enter some tangled swamps. The marketing people need to know when they are entering a swamp and seek a competent guide.

Frankly, I don’t have much sympathy for those who wring their hands over the expense of hiring an experienced guide for the swamp. If you cannot bear the expense, it is simple to stay out of the swamp. The Williams court quoted another classic labeling law case, “It is not difficult to choose statements, designs, and devices which will not deceive.” United States v. Ninety-Five Barrels More or Less of Alleged Apple Cider Vinegar, 265 U.S. 438, 443 (1924). (Also in chapter three of my book, Food Regulation: Law, Science, Policy, and Practice.)

Gerber also offered compliance with FDA’s requirements as a defense. Surprisingly, the district court bought into this, noting that it believed that “the FDA authorizes the way in which Gerber labels snacks.” The lower court should have known better. Food Law 101: FDA does not authorize or approve labels.

This is one of the inherent tradeoffs involved in the policy decision regarding pre-market approval. If you want federal pre-emption of states, you have to be willing to grant more authority to the federal government. You can’t have your fruit juice snacks and eat them too.

Pharming Goats for Antithrombin

The Food and Drug Administration (FDA) approved for the first time the sale of a drug made by genetically engineered animals. The goats are genetically engineered to secrete antithrombin in their milk. The drug is needed by patients with a hereditary deficiency of antithrombin in their blood.

The European Union (EU)—although known for dragging their feet on the approval of genetically engineered (GE) products—approved this drug in 2006. 

Photo: GTC Biotherapeutics. For more information, see Shankar Vedantam, Washington Post, Drug Made In Milk of Altered Goats Is Approved, and MSNBC, FDA OKs drug from genetically altered animals.

Thursday, February 05, 2009

DeLauro Reintroduces Food Safety Modernization Bill

Flanked by a mother whose son was sickened by Salmonella poisoning from peanut butter and a son whose mother died of Salmonella poisoning from peanut butter, U.S. Rep. Rosa DeLauro reintroduced a plan to restructure the Food and Drug Administration (FDA).

From the press release:

“This salmonella outbreak represents the full-scale breakdown of a patchwork food safety system. And it should act as the final wake up call,” said DeLauro. “That is why, today, I am introducing the Food Safety Modernization Act to separate food safety regulation from drug and device approvals and to restore the balance that has long been missing at Health and Human Service. . . .

In addition to the structural change, The Food Safety Modernization Act also updates food laws and would change the focus to preventing disease-causing contamination. The bill would utilize a modern approach to food safety by requiring food producers to: control health hazards in their operations; meet federal standards for preventing or removing contaminants and pathogens from food; and be subject to regular inspections by federal officials based on the risk profile of the products they produce. When prevention fails, the Food Safety Administrator would have sufficient enforcement authority, including authority to order recalls, seize unsafe food before it enters the market, and impose fines on companies that refuse to abide by the law.

More in available on this story here, and here. Copy of the bill (S.3385) is available here.

Wednesday, February 04, 2009

FDA Supplement Warning Letters: 2008 Year in Review

Ivan Wasserman and Svetlana Walker have published the useful FDA supplement warning letters: 2008 year in review in (27-Jan-2009). Wasserman and Walker analyzed the 44 warning letters issued by the US Food and Drug Administration (FDA) to supplement marketers last year. This type of analysis can provide insight into the types of claims and other issues that are at the top of FDA’s list for enforcement.

FDA’s emphasis on cancer claims made on internet web sites is no surprise as this has long been a red flag to the agency. All 44 of the warning letters involved some type of concern regarding disease claims (36 mentioned cancer claims). Website claims were mentioned in 41 of the letters. By comparison, only three warning letters were sent following facility inspections.

The amount of letters triggered by website reviews highlights the importance of diligence when it comes to creating website content. FDA may consider any statement that appears on a company’s web pages to be a labeling claim. Consumer testimonials, even when truthful can still be misleading, and when used in a company’s marketing, FDA will consider these testimonials to be the same as direct claims.

In addition, FDA considers metatags (hidden tags used direct search engines) to also be part of a product’s claims. For instance, “gout” as a metatag for a dietary supplement webpage would drive customers seeking gout information to that website. Almost half of the 2008 FDA Warning Letters sent to dietary supplement marketers identified the use of disease terms in metatags.

Hearing to be held on Salmonella outbreak Feb. 11

The House of Representatives Energy and Commerce Committee has announced plans to hold a hearing on Feb. 11 to examine the recent Salmonella outbreak associated with peanut butter manufactured by the Peanut Corp. of America (PCA). “There are still far too many questions surrounding FDA’s role in allowing the PCA to distribute contaminated products,” said Rep. Bart Stupak, Chairman of the Oversight and Investigations Subcommittee. “We have already requested a number of documents from the company and I hope this hearing will bring to light not only what went wrong but also what the FDA and industry can do to prevent future outbreaks.” For more information, see the press release.

FDA Commissioner Update

From the In Vivo Blog, Announcement Timing Provides Clues:

“Comments out of the White House that an announcement is imminent on President Obama’s choice for FDA commissioner indicate the pick is someone who has already been thoroughly vetted.

“Duke cardiologist Robert Califf and Baltimore Health Commissioner Joshua Sharfstein have been formally interviewed for the job by HHS Secretary-designate Tom Daschle and would appear to be the two most serious names to make the final cut (“The Pink Sheet,” January 19, 2009, p. 3). . . .”

Tuesday, February 03, 2009

Peanut scare a new crisis of deregulation

CYNTHIA TUCKER wrote an editorial on the peanut scare in  the Atlanta Journal Constitution (Sunday, Feb. 1, 2009):

The good people of Blakely, Ga. — a town that calls itself the “Peanut Capital of the World” — are relearning long-lost lessons about the perils of unfettered capitalism. Along with former Wall Street secretaries and unemployed bank clerks, they have become collateral damage in an age of deregulation and an ideology that defined government as always the problem, never the solution.

Virginia-based Peanut Corp. of America shut down its processing plant outside Blakely, in southwest Georgia . . .  the locals wonder about the future of the plant, which has laid off most of its 50 or so employees. . . .

Food and Drug Administration inspectors say plant managers found evidence of salmonella in its peanut butter products but still sold them, in violation of the law. Plant executives had a very simple reason for hesitating to destroy the products — it would have cost the company money.

Instead, they bought the services of an outside lab, which declared the peanut butter safe. (That sounds suspiciously like Wall Street, which paid ratings agencies that declared exotic financial instruments to be nearly risk-free. Those financial instruments have since wrecked the world banking system.)

Since then, salmonella traced to the facility has sickened more than 500 people in 43 states and may be linked to the deaths of several others.

Did plant executives violate the rules? Apparently. Should they be prosecuted? Absolutely.

But wouldn’t consumers and — in the long run — even the plant, its executives and employees have been better off with a tightly regulated system that would have prevented those violations? With more federal and state scrutiny, plant managers would have been less likely to break the rules because they would have feared getting caught.

It’s simple human nature. Any system of rules and regulations is only as good as its enforcement. And lately, the nation’s food-safety enforcement has been lax. . . .

Those were the years of cutting taxes and minimizing government, which was routinely denounced as wasteful, inept and overbearing. Businesses were allowed to police themselves, a laughable concept that suggests that business executives are exempt from the human foibles that plague the rest of us, including greed. . . .

Now, however, Georgia legislators, including Republicans, are suddenly clamoring for stiffer laws and more oversight. Indeed, the entire country is in the midst of a cultural shift as Americans rediscover the many reasons that smart government oversight of commerce and industry makes good sense.

In the decades he has been involved in food safety, Doyle [director of the Center for Food Safety at the University of Georgia] said, he has encountered many companies where executives are “highly committed” to ensuring the safety of food. But other companies “just don’t want to get caught,” he said.

Of course, it’s hard for consumers to tell the difference, which is why strict government oversight in necessary.

• Cynthia Tucker is editorial page editor. Her column appears Sundays.

Sunday, February 01, 2009

Caution: Eggs contain Egg

Beware: The daft egg-box warning that contents 'may contain eggs'” reports Helen Dowd in the Mail online (Jan. 24, 2009):

In these health-conscious times food companies are increasingly keen to warn consumers if ingredients may cause allergic reactions.

 But one firm has gone a step further by advising shoppers that its boxes of eggs contain...egg.

 The Happy Egg Company’s six-pack of eggs – which features the company’s name and is decorated with a picture of an egg and a cartoon chicken – contains the message ‘allergy advice: contains egg’ inside the lid of the boxes. . . .

 The firm initially claimed that supermarkets’ strict labelling criteria were to blame for the overzealous warning.

 A spokesman said: ‘Some retailers insist on this information within their packs as part of a due diligence procedure. Any products deemed as potentially allergenic are included in this. A crazy world, but occasionally we have to do silly things to cover ourselves.’

Later The Happy Egg Company  admitted it had chosen to print the advice of its own volition – after the supermarkets involved said they only demand producers comply with the law – adding: ‘We have to state the obvious to cover all eventualities.’

But bizarrely, the company has not printed the warning in its boxes of ten eggs. . . .

The Happy Egg Company is sticking to its story that this labeling was to be precautionary.  However, this “Allergy Advice” is so ridiculously overzealous, I  am guessing that the label reflects its designer's wit. Moreover, this is from the United Kingdom, not the US. So you cannot blame this one on Bill Marler and US tort law. I can almost see this as a Monty Python skit. 

Thanks to Katherine Teodosic for alerting me to this one.