Thursday, July 31, 2008

UK Food Standards Agency revised guidance for the use of the terms Fresh, Pure, Natural etc.

UK’s Food Standards Agency has revised its advice on the use of labeling terms such as “fresh,” “pure,” and “natural.”

The revised guidance includes advice on the use of new terms, including include: farmhouse pâté, handmade, quality, selected, premium, finest and best. It also has new advice for some of the terms that were in the previous guidance – and advises against the use of some terms that can cause confusion.

For more information, click here.

Wednesday, July 30, 2008

EFSA Yes or No on Cloned Meat?

"EU food safety experts say NO to cloned meat."
The European Food Safety Authority will not allow the marketing of meat and milk from cloned animals in the European Union, EU sources say. "EFSA says it has increased concerns regarding animal welfare and possible concerns regarding food safety due to the limited data available," according to a source close to the European Commission's probe. The Daily Mail (London)
(7/24) , Reuters (7/23).

but . . .

EFSA reaffirms safety view of cloned meat and dairy products
Meat and dairy products from cloned pigs and cattle are probably safe for human consumption, the European Food Safety Authority (EFSA) concluded in its scientific opinion on animal cloning released today . . . FoodProductionDaily.com (24-Jul-2008).

DA Seeks Comments on Newly-Enacted Section 301(ll) of the FD&C Act

The U.S. Food and Drug Administration recently published a notice in the Federal Register requesting data, information, and comments relevant to the agency's implementation of Section 912 of the Food and Drug Administration Amendments Act of 2007 (FDAAA). We are issuing this Constituent Update to alert you to this request and to encourage you to submit relevant data, information, and comments. You may submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. You may also submit electronic comments to www.regulations.gov. All comments are to be submitted by October 27, 2008.

Section 912 of FDAAA establishes section 301(ll) in the Food, Drug, and Cosmetic Act, which prohibits the interstate shipment of certain foods to which an approved drug or a licensed biological product has been added. Section 301(ll) also prohibits the interstate shipment of foods containing an added drug or a biological product that has been the subject of substantial clinical investigations, the existence of which has been made public. Foods that may be affected by the provisions of section 301(ll) include human food, including infant formula, medical foods, and dietary supplements, and their ingredients; food contact substances, including most food packaging; and animal feed, including pet food and feed ingredients. We are seeking comments about the impact of section 301(ll) on food in all its forms, including food ingredients, categories of food, and finished food products.

We believe that section 301(ll) presents a number of questions of statutory interpretation for our consideration. So that we may better understand the impact of various interpretations of section 301(ll), we are requesting comments on possible approaches to implementation and the impact of those approaches. We have included in the Federal Register notice a series of questions to guide your responses to our request for comments.

If you have questions about this request for comments, you may contact Catherine Copp at Catherine.copp@fda.hhs.gov.

USDA details COOL interim final rules

The U.S. Department of Agriculture yesterday issued an interim final rule for the mandatory country of origin labeling (COOL) program that will become effective on Sept. 30. The rule covers muscle cuts and ground beef (including veal), lamb, chicken, goat, and pork; perishable agricultural commodities (fresh and frozen fruits and vegetables); macadamia nuts; pecans; ginseng; and peanuts -- as required by the 2002 and 2008 Farm Bills. USDA implemented the COOL program for fish and shellfish covered commodities in October 2004.

Commodities covered under COOL must be labeled at retail to indicate their country of origin. However, they are excluded from mandatory COOL if they are an ingredient in a processed food item. USDA has also revised the definition of a processed food item so that items derived from a covered commodity that has undergone a physical or chemical change (e.g., cooking, curing, smoking) or that has been combined with other covered commodities or other substantive food components (e.g., chocolate, breading, tomato sauce) are excluded from COOL labeling.

Food service establishments, such as restaurants, lunchrooms, cafeterias, food stands, bars, lounges, and similar enterprises are exempt from the mandatory country of origin labeling requirements.

The rule outlines the requirements for labeling covered commodities. It reduces the recordkeeping retention requirements for suppliers and centrally-located retail records to one year and removes the requirement to maintain records at the retail store. The law provides for penalties for both suppliers and retailers found in violation of the law of up to $1,000 per violation.

The rule prescribes specific criteria that must be met for a covered commodity to bear a "United States country of origin" declaration. In addition, the rule also contains provisions for labeling covered commodities of foreign origin, meat products from multiple origins, ground meat products, as well as commingled covered commodities.

USDA plans to conduct education and outreach activities during the six months following the rule's effective date to help the industry comply with the law.

The full text of the interim final rule will be published in the Aug. 1, 2007, Federal Register.

Copies of the interim final rule and additional information can be found at: http://www.ams.usda.gov/COOL.

Tuesday, July 29, 2008

Warning: May Contain Guff

Warning: May Contain Guff, Conor Pope, Irish Times (Jul. 28, 2008)

There was a time when the only the makers of certain shampoos and moisturisers could get away making absolutely ridiculous claims about their products. In recent years, however, more and more manufacturers have climbed on board the crazy train and now if you take a walk through your local supermarket, you will quickly lose count of the number of foods that promise to keep you alive and gorgeous looking for longer.

There are sugary cereal bars which use extra nutrients and calcium to distract from their calorific content, vegetable spreads that promise to lower your cholesterol in a heart beat and yoghurt drinks with unpronounceable additives which, the ads say, will improve you digestion and immunity. And because these products are even better than real food — as the manufacturers will have you believe — they can justify charging a premium for them. It's a win win situation, for them at any rate.

Last year the increasingly outlandish claims being made on some food labels finally prompted the EU to take action, and legislation was introduced prohibiting manufacturers from making unverifiable health claims about their products. In the future, all nutritional or health claims will have to be backed by proper scientific evidence, although certain products are hanging in there after getting a two-year derogation so they can get their houses in order.

Functional foods, which claim to have beneficial nutrients added, are not entirely without merit, however. Earlier this month Enterprise Ireland announced €20 million in funding for the establishment of a National Functional Foods Research Centre. The new centre will bring together four of the biggest food groups in the country - Dairygold Food Ingredients, Glanbia Nutritionals, Carbery and Kerry Ingredients Ireland - to maximise the commercial value of milk.

The companies will work in conjunction with researchers from UCD, UCC, UL and Teagasc to enhance foods (including infant formula, dairy spreads, yogurts and cheese) with extra nutrients. Speaking at the launch, the Tánaiste and Minister for Enterprise, Trade and Employment Mary Coughlan said the investment would "lead to the delivery of new high-value, innovative food products for the health conscious consumer".

Gov. Schwarzenegger signs law banning trans fats in restaurants

Gov. Schwarzenegger signs law banning trans fats in restaurants, Patrick McGreevy, Los Angeles Times (Jul. 25, 2008).

“California became the first state to require restaurants to cook without artery-clogging trans fats, such as those in many oils and margarines, under restrictions signed into law Friday by the health-conscious governor. Gov. Arnold Schwarzenegger, a physical-fitness advocate and crusader against obesity, sided with legislators who said the measure would help get the fat out of Californians who are too dependent on fast food.”

"California is a leader in promoting health and nutrition, and I am pleased to continue that tradition by being the first state in the nation to phase out trans fats," Schwarzenegger said. "Consuming trans fat is linked to coronary heart disease, and today we are taking a strong step toward creating a healthier future for California. . . .”

Under the new law, most California eateries must stop cooking with all but small amounts of trans fat by 2010. The California Restaurant Association opposed the legislation, but voiced confidence that members will meet the deadline. A copy of the law is available here.

California is seen as a leader in this matter, and it they are successful, we may seen the law copied by other states. However, I wonder if some form of restaurant nutrition labeling, particularly saturated fat, trans fat, cholesterol, sodium, and calories, might have been more effective in promoting better health. “Trans fat free” does not mean healthy.

Friday, July 25, 2008

Critical Report on Claims of Organic Food's Nutritional Superiority

A report by Dr. Joseph Rosen from Rutgers University, US, was published this week by the American Council on Science and Health (ACSH) entitled "Claims of Organic Food's Nutritional Superiority: a Critical Review." Dr. Rosen analyzed a pro-organic report by Charles Benbrook and colleagues at the Organic Trade Association's Organic Center and found the data had been selectively chosen and presented to "prove" the desired point. When Dr. Rosen recalculated some of the organic data, correcting inaccuracies, he concluded that the conventional products were actually 2% more nutritious than the organic varieties. The complete report is available at: http://www.acsh.org/docLib/20080721_claims_of_organic_foods.pdf.

Saturday, July 19, 2008

When Beer is not Beer

The Alcohol and Tobacco Tax and Trade Bureau (“TTB”) exercises jurisdiction over labeling of distilled spirits, wines, and malt beverages subject to the Federal Alcohol Administration Act (“FAA Act”), but FDA regulates the labeling of other alcohol beverages, such as wine coolers with less than seven percent alcohol by volume.

TTB issued a ruling clarifying that certain brewed products—which meet the definition of a “beer” under the Internal Revenue Code (IRC)—do not meet the definition of “malt beverages” under the FAA Act. The IRC broadly defines “beer” as “beer, ale, porter, stout, and other similar fermented beverages (including saké or similar products) of any name or description containing
one-half of 1 percent or more of alcohol by volume, brewed or produced from malt, wholly or in part, or from any substitute therefor.” On the other hand, the FAA Act defines “malt beverage” as a beverage made by the alcoholic fermentation of malted barley with hops, with or without other cereals and other carbohydrates.

Beers that do not conform to the definition of a “malt beverage” in the FAA Act are outside the scope of the FAA Act and, therefore, are not subject to the labeling, advertising, and other provisions of the TTB regulations under the FAA Act. This means that brewers and importers of such products are not required to obtain a certificate of label approval for these beers. However, such beverages are subject to FDA’s ingredient and other labeling requirements.

Sake and similar beverages—when they contain at least seven percent alcohol by volume—fall within the definition of “wine” under the FAA Act. Thus, those beverages continue to be subject to the requirements of the FAA Act.
Hat Tip to Ricardo Carvajal for his blog post on this topic Beer With Nutrition Labeling Becomes a Reality.

Improving Food Safety: Insights from Intensive Care

Paraphrasing Tom Sawyer, a person who takes a bull by the tail once, learns sixty or seventy times more than a person who hasn’t. Perhaps no one has seen the inside of as many intensive care units for foodborne illness as Bill Marler.

Gain some of Marler’s insight on improving food safety by reading his latest commentary, E. coli O157:H7 is a powerful and deadly bacterium. “You cannot see it, taste it, or smell it. 250,000 E. coli O157:H7 (E. coli) bacteria will fit on the head of a pin. Ten to 50 will kill your child or your grandmother.”

Make sure you read to through to the end of the “Might I suggest” section.

Tuesday, July 15, 2008

GAO Report: Selected Countries' Systems Can Offer Insights

The Government Accountability Office (GAO) released a new report on July 14, "Food Safety: Selected Countries' Systems Can Offer Insights into Ensuring Import Safety and Responding to Foodborne Illness." (GAO-08-794, June 10.)

For the full report, click here.

For highlights, click here.

Thursday, July 10, 2008

FDA: Synthetic Ingredients May be "Natural"?

In a recent letter to the Corn Refiners Association, the Food and Drug Administration (FDA) stated that synthetically produced high fructose corn syrup (HFCS) may be labeled as “natural” under certain circumstances.

FDA longstanding policy on “natural” claims was, “not to restrict the use of the term ‘natural’ except for added color, synthetic substances, and flavors as provided in §101.22. Additionally, the agency will maintain its policy regarding the use of ‘natural,’ as meaning that nothing artificial or synthetic (including all color additives regardless of source) has been included in, or has been added to, a food that would not normally be expected to be in the food. Further, at this time the agency will continue to distinguish between natural and artificial flavors as outlined in §101.22.” 58 Fed. Reg. 2407 (Jan 6, 1993).

The July 3 FDA letter states that the agency would object to calling HFCS “natural,” if synthetic enzymes or synthetic processing aids remained in the final product. However, FDA does not object to synthetic HFCS being labeled as “natural” if no synthetic enzymes or processing aids end up in the final product.

Frankly, this is a tortuous interpretation. Unless you like dancing on a pin, I urge caution in applying this “clarification.”

Hat tip to Lynn Kuntz of Food Product Design for bringing this to my attention.

Dingell, Stupak Announce Hearing on FDA's Struggle with Salmonella Outbreak

Reps. John D. Dingell (D-MI), Chairman of the Committee on Energy and Commerce, and Bart Stupak, Chairman of the Subcommittee on Oversight and Investigations, today announced plans to hold a hearing related to the Salmonella Saintpaul outbreak.

Thursday, July 03, 2008

Salmonella Saintpaul Outbreak: Concerns About FDA/CDC Lack of Trace Back The Control Group

Interesting comments from Jim Prevor, the Perishable Pundit at http://www.perishablepundit.com/index.php?date=7/03/08:

. . . It was good news to learn that CDC was basically starting anew and doing new survey work with people who became ill after June 1, 2008. This survey work would involve additional questions and presumably build on learning from inadequacies in the initial investigation of those who fell ill in April and May. . . .

What was shocking — and very disappointing for the produce industry — was word that even in this new investigation, CDC is not doing any traceback of the control group. This group consists of people similar in demographics to the ill people but who did not fall ill.

Our interview with Michael T. Osterholm PhD, M.P.H., focused on the necessity for doing traceback with the control group. Here is what Dr. Osterholm said:

…it is not biologically plausible to have Mexico and Florida both at the source of this outbreak. It epitomizes the ineptitude of the investigation. FDA and CDC should have obtained tomato product consumption information from both outbreak cases and controls. They needed to conduct full fledged tracebacks all the way back to the source not only of the sick cases but of the control group as well.

The epidemiology conducted to learn what product is associated with this outbreak by interviewing those sick and those not sick on what they were eating is a prerequisite but the epidemiology needed to go further. It was critical for the investigators to learn the locations of where both the cases and controls ate tomatoes and trace back from there.

When doing the traceback, you may come up with a few possibilities of where the tomatoes came from. If you collect data over time of the cases and controls, using the same methods to make the product association, you may find 85 percent of outbreak cases trace back to a certain field or grower, or re-packer versus the control product. Then you begin to get a much better handle on where product came from.

Q: Why did the government forego this strategy?

A: FDA and CDC have not made this a priority. They will never find a silver bullet by just tracing back a product. They’re looking for a cluster that matches up exactly with the one gun barrel. They’re under the false impression that they’re going to get a clean, clear-cut answer by finding the magic cluster. They need to do this case/control approach.

Now whatever happened with the initial investigation, whatever judgments or considerations were made, this much is beyond dispute: It didn’t work.

A quote attributed to Albert Einstein defined insanity as doing the same thing over and over again yet expecting different results. So surely CDC should be open to enhancing its methodology. Certainly there is no way that doing a traceback on the control group could hurt.

We have Dr. Osterholm, a highly credible person with extensive experience, saying this is a necessity. This is from a man who was doing traceback in Salmonella investigations on tomatoes a decade ago.

So, we have a methodology that has not been working, a highly credible source suggesting a specific improvement in that methodology, yet when asked, CDC gave a simple response of no, it is not tracing back the control group. . . .

This CDC also needs to consider its dismissive manner. An issue such as this merits an explanation. In light of the failure of the last traceback and the input from Dr. Osterholm, if CDC doesn’t want to do a traceback on the control group, it should have the decency to explain why to the general public.

Does CDC lack the resources required? Does it have a substantive disagreement with Dr. Osterholm?

The people at CDC are hired by the citizens of America to handle this portion of their affairs. A decent respect for the people who pay the bills requires CDC to be more transparent in its decision-making process..

Tuesday, July 01, 2008

IDFA Files Lawsuit to Stop Ohio's No-rBST Labeling Law

The International Dairy Foods Association (IDFA) filed a lawsuit against the State of Ohio challenging the state's new regulations regarding the labeling of dairy products from cows that have not been treated with artificial growth hormones. In the lawsuit, IDFA says the Ohio rule interferes with the First Amendment right of its members to communicate truthful information to Ohioans and with interstate commerce. “The practical effect of the Ohio rule silences manufacturers of dairy products and prevents Ohioans from knowing whether artificial growth hormones have been used in dairy products,” said Peggy Armstrong, IDFA communications director. To read the news release, click here. To view IDFA's complaint, motion and brief, click here.