Food Law Prof Blog

Kellogg's discontinues cereal box "Immunity" claims

Kellogg has announced that it will stop using the big banner on the Cocoa Krispies proclaiming that the cereal "helps support your child's immunity." 

Here's a November 5, 2009, article from the Wall Street Journal:
Kellogg: Rice Krispies Won’t Protect Your Kid From Swine Flu

And here's the Kellogg's Press Release

FDA analyzing front of package labels

The FDA has issued a Dear Industry letter on front of package or point of purchase nutrition labeling.

From the Institute of Food Technologists Weekly:

The U.S. Food and Drug Administration (FDA) said Oct. 20 that it would seek to clear up the confusion caused by a surge of nutritional claims that manufacturers have begun to make on packaged food labels. Point of purchase labeling including Front of Package (FOP) labeling is voluntary information that is intended to convey to consumers the nutritional attributes of a food. Point of purchase labeling often includes symbols that are typically linked to a set of nutritional criteria developed by food manufacturers, grocery stores, trade organizations, and health organizations. The selected nutrients and the nutrient levels required for eligibility vary among the different symbol programs in use.  continue

The graphic above is the traffic light version that has been floating about for some time now.

  

FDA Video Update on Food Allergies

FDA has posted a series of videos for consumers.  Here's the one on Food Allergies:

  Food Allergies: Reducing the Risks (video)

Food allergies can range from merely irritating to life-threatening. FDA is working to ensure that major allergenic ingredients in food are accurately labeled. In this Consumer Update video Felicia Billingslea, FDA Director of Food Labeling and Standards, provides tips to help prevent allergic reactions and explains the difference between food allergies and food intolerance.

Dietary Supplement Labeling Guide

Here's a nifty table showing some of the differences between dietary supplement labeling rules and conventional food labeling rules.  The table is presented on Food Label News, an online newsletter by Food Consulting Company, which provides nutritional analysis and labeling advice. From their labeling guide:

A dietary supplement is a product taken by mouth that contains a “dietary ingredient” intended to supplement the diet; “dietary ingredients” include: vitamins, minerals, herbs/botanicals, amino acids, enzymes, organ tissues, glandulars, metabolites, extracts or concentrates. Dietary supplements have many forms: . . .

My son just sent me this xkcd cartoon about food labels. Click on the link to view on their website, and be sure to hold your mouse over the picture for the rest of the caption. 

Testing and Certification for "non-GMO" foods

From the New York Times:

Alarmed that genetically engineered crops may be finding their way into organic and natural foods, an industry group has begun a campaign to test products and label those that are largely free of biotech ingredients. . . .

Hundreds of products already claim on their packaging that they do not contain genetically modified ingredients, but with little consistency in the labeling and little assurance that the products have actually been tested. The new labeling campaign hopes to clear up such confusion.

Read the article here

Serving Size for Lollipops

A post on Small Bites blog raises a question about serving sizes:

In one corner, a colorful display of medium-sized “whirly pops” caught my eye.

They were your standard rainbow swirl lollipops (that swirl can be quite hypnotic!).

I grabbed one, turned it around, and could not believe the nutrition label.

The serving size for this single-serve three-ounce lollipop? 

Read the rest of the post

Reference serving sizes are provided in regulations at 21 CFR 101.12

Study: Allergen Labeling Not Clear Enough

A study recently published online in the Journal of Allergy and Clinical Immunology concludes that better allergen labeling is warranted.  Here's the abstract:

Background The Food Allergy Labeling and Consumer Protection Act became effective January 1, 2006, and mandates disclosure of the 8 major allergens in plain English and as a source of ingredients in the ingredient statement. It does not regulate advisory labels.

Objective We sought to determine the frequency and language used in voluntary advisory labels among commercially available products and to identify labeling ambiguities affecting consumers with allergy.

Methods Trained surveyors performed a supermarket survey of 20,241 unique manufactured food products (from an original assessment of 49,604 products) for use of advisory labels. A second detailed survey of 744 unique products evaluated additional labeling practices.

Results Overall, 17% of 20,241 products surveyed contain advisory labels. Chocolate candy, cookies, and baking mixes were the 3 categories of 24 with the greatest frequency (≥40%). Categorically, advisory warnings included “may contain” (38%), “shared equipment” (33%), and “within plant” (29%). The subsurvey disclosed 25 different types of advisory terminology. Nonspecific terms, such as “natural flavors” and “spices,” were found on 65% of products and were not linked to a specific ingredient for 83% of them. Additional ambiguities included unclear sources of soy (lecithin vs protein), nondisclosure of sources of gelatin and lecithin, and simultaneous disclosure of “contains” and “may contain” for the same allergen, among others.

Conclusion Numerous products have advisory labeling and ambiguities that present challenges to consumers with food allergy. Additional allergen labeling regulation could improve safety and quality of life for individuals with food allergy.

Journal of Allergy and Clinical Immunology 2009, Vol. 124, No. 2, pp. 337-341 “Audit of manufactured products: Use of allergen advisory labels and identification of labeling ambiguities” Authors: M.M. Pieretti, D. Chung, R. Pacenza, T. Slotkin, and S.H. Sicherer

When Can FDA Regulate Beer Labeling? When the Beer is not a "Malt Beverage"

Generally speaking, the usual food regulators -- FDA and USDA -- do not regulate alcohol beverages.  Most alcohol beverages are regulated by the Alcohol and Tobacco Tax and Trade Bureau (TTB), which is part of the Department of the Treasury (just like the IRS!) 

Last summer TTB issued a ruling explaining that some beverages qualify as "beer" for excise tax purposes even though they are not "malt beverages" subject to TTB jurisdiction.

Section 5052(a) of the IRC (26 U.S.C. 5052(a)) defines the term “beer,” for purposes of Chapter 51, 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.” Essentially the same definition appears in the TTB regulations at 27 CFR 25.11. In addition, with reference to what may be a substitute for malt, § 25.15(a) of the TTB regulations (27 CFR 25.15(a)) states that “[o]nly rice, grain of any kind, bran, glucose, sugar, and molasses are substitutes for malt.”

The Federal Alcohol Administration Act, however, gives TTB authority to regulate "the labeling and advertising of wine, distilled spirits, and malt beverages."

Since the Internal Revenue Code definition of "beer" is broader than just "malt beverages," there are some beverages subject to the excise tax, but over which TTB was not given authority.

Accordingly, a fermented beverage that is brewed from a substitute for malt (such as rice or corn) but without any malted barley may constitute a “beer” under the IRC but does not fall within the definition of a “ malt beverage” under the FAA Act. Similarly, a fermented beverage that is not brewed with hops may fall within the IRC definition of “beer” but also falls outside of the definition of a “malt beverage” under the FAA Act. (TTB Ruling 2008-3)

So, FDA has issued Draft Guidance for labeling of those "beers" that are not "malt beverages":

Guidance for Industry: Labeling of Certain Beers Subject to the Labeling Jurisdiction of the Food and Drug Administration; Draft Guidance

From the Background section:  Alcoholic beverages are regulated by FDA under the FFDCA, which includes "articles used for food or drink" in the definition of "food." 21 U.S.C. 321(f). As such, alcoholic beverages are subject to the FFDCA adulteration and misbranding provisions, and implementing regulations, related to food. For example, manufacturers of alcoholic beverages are responsible for adhering to the registration of food facilities requirements in 21 CFR part 1 and to the good manufacturing practices in 21 CFR part 110. However for the labeling of alcoholic beverages, as reflected in the 1987 Memorandum of Understanding (MOU) between FDA and TTB's predecessor agency (ATF) (Ref. 2), TTB is responsible for the promulgation and enforcement of regulations with respect to the labeling of distilled spirits, wines, and malt beverages pursuant to the FAA Act. In TTB Ruling 2008-3, dated July 7, 2008, TTB clarified that certain beers, which are not made from both malted barley and hops but are instead made from substitutes for malted barley (such as sorghum, rice or wheat) or are made without hops, do not meet the definition of a malt beverage under the FAA Act.³ Accordingly, TTB stated in its Ruling that such products (other than sake, which is classified as a wine under the FAA Act), are not subject to the labeling, advertising, and other provisions of the TTB regulations promulgated under the FAA Act.

read more

 

Third Circuit Holds Snapple Suit Not Preempted: Stacy Holk v. Snapple Beverage Corp.

The Third Circuit Court of Appeals has ruled that a consumer action against the makers of Snapple is not preempted by the Food Drug and Cosmetic Act.

The case is Stacy Holk v. Snapple Beverage Corp, 08-3060, 3rd U.S. Circuit Court of Appeals (Philadelphia).  Here's an article about it from The American Lawyer Litigation Daily:

Third Circuit Rejects Preemption Defense and Reinstates Consumer Fraud Class Action Against 'All Natural' Snapple 
By Alison Frankel

August 13, 2009 -- We here at the Litigation Daily regard Snapple diet lemon iced tea as pretty much the elixir of life. We drink it by the bucketful. We like the way it tastes, and, frankly, we've always been amused by the company's cheeky attitude and advertising. But apparently not everyone is as charmed as we are. In a 30-page ruling on Wednesday, a three-judge panel of the U.S. Court of Appeals for the Third Circuit revived a New Jersey statewide class action against Snapple, finding that federal regulation does not preempt consumer fraud claims involving Snapple's "all natural" labelling.

Politics of kosher hot dogs

This piece from the Baltimore Jewish Times has some interesting background on the history of the hot dog.  I only eat non-meat hotdogs, myself, but kosher certification symbols (like all voluntary label symbols) get me excited.  Thanks to Steven H. Sholk for sending this my way:

Hebrew National & Kosher Politics
What’s kosher about answering to a higher authority?

. . . . One of the oldest forms of processed food, the common sausage can be traced as far back as the Roman Empire. (It was mentioned in Homer’s “Odyssey” in the ninth century B.C.)

According to food historians, the edible “dachshund” or “little dog” was created in the late 1600s by Johann Georghehner . . .

FDA to study consumer reactions to front-of-package nutrition labels

This came from Food Label News:

FDA is proposing to conduct an experimental study to assess quantitative consumer reactions to front-of-package nutrition symbols. The proposed study is described in the June 1, 2009, Federal Register.

In part the study design uses a Web-based survey to collect information from a sample of 2400 adults. Participants would view a label from a set of food labels that vary in the presence and type of symbol, the type of food product, and the quality of nutritional attributes of the product. The study would measure various consumer reactions described in the notice.

TIME Magazine on posting restaurant calorie info

Interesting piece on Time.com (June 29, 2009) on the restaurant calorie labeling issue:

Fast Food: Would You Like 1,000 Calories with That?, by Sean Gregory

How sloppy is that triple Whopper with cheese? It has 1,250 calories, or 62.5% of the recommended 2,000-calories-per-day diet. The Fried Macaroni and Cheese from the Cheesecake Factory? Try 1,570 calories — according to health experts, you're better off eating a stick of butter. . . .

To be fare, the cheesecake probably has more nutrients than the butter, and it tastes better, so there are psychic benefits.  I don't think calories are the whole story.  But the article looks interesting anyway.

DMB

When is breakfast cereal a "drug"? When it's Cheerios

General Mills, maker of Cheerios, received a letter from the FDA yesterday warning that the health claims about fiber and heart disease on Cheerios boxes are unauthorized and make the cereal into a "drug." The claims about  fiber show that the product is "intended for use in the prevention, mitigation, or treatment of a disease." 

Some Cheerios boxes say "You can lower cholesterol 4% in 6 weeks."

The letter also states that the Cheerios website is treated part of its labeling because the URL is printed on the box, and the website says "Heart-healthy diets rich in whole grain foods can reduce the risk of heart disease." This statement is not an authorized health claim.

Here are some of the requirements for "qualified health claims" regarding fiber and coronary heart disease from 21 CFR 101.77(c)(2)(i):

(A) The claim states that diets low in saturated fat and cholesterol and high in fruits, vegetables, and grain products that contain fiber may or might reduce the risk of heart disease;

(B) In specifying the disease, the claim uses the following terms: heart disease or coronary heart disease;

(C) The claim is limited to those fruits, vegetables, and grains that contain fiber;

(D) In specifying the dietary fiber, the claim uses the term fiber, dietary fiber, some types of dietary fiber, some dietary fibers, or some fibers; the term soluble fiber may be used in addition to these terms;

(E) In specifying the fat component, the claim uses the terms saturated fat and cholesterol; and

(F) The claim indicates that development of heart disease depends on many factors; and

(G) The claim does not attribute any degree of risk reduction for coronary heart disease to diets low in saturated fat and cholesterol and high in fruits, vegetables, and grain products that contain fiber.

What is implied preemption in food liability cases?

FDA Law Blog had a post on February 10 -- California District Court Rules Against FDA Preemption of “Natural” Claim, describing a ruling in a California case about whether a product containing high fructose corn syrup can be labeled as "all natural."

Ricardo Carvajal of FDA Law Blog notes,

"This latest decision is likely to add to the existing confusion over the precise contours and reach of the doctrine of implied preemption in food liability cases.  Notably, FDA has indicated that products that contain HFCS can be labeled as "natural," depending on how the HFCS is made."
"

Final USDA COOL rules, January 2009

(Brought to my attention by a Center for Food Safety press release dated January 16, 2009.) USDA issued final country of origin labeling(COOL) rules January 15, 2009. The rules are available in the Federal Register.

Center for Food Safety criticized the rules because they contain some fairly broad loopholes -- mixed foods are considered to be "processed," for example, and are thus not subject to the requirement, even if the product contains two different types of covered commodities (such as peas and carrots).

Similarly a retail product that contains a covered commodity and a non-covered commodity, like a bag of lettuce with a dressing packet are not included in COOL.

Finally, items that are cooked, breaded, marinated, canned, smoked, cured, roasted, or restructured (e.g. emulsified or extruded) are not required to bear a COOL label.

Is this riveting, or what? Without analyzing the regs myself, it does sound as if one could ship a package of "frozen peas with a single bit of carrot" and escape the rules.

Yogurt Standards

Two wees ago, the FDA proposed a change to the standards of identity for yogurt. FDA Law Blog has a nice post on the proposed rules: FDA Law Blog
The proposal itself is in the Federal Register (here).

From FDA Law Blog:

FDA has issued a proposed rule that would amend the standard of identity for yogurt and revoke the regulations on standards of identity for lowfat and nonfat yogurt. Under § 401 of the FDC Act, FDA has the authority to establish a reasonable definition and standard of identity for any food to “promote honesty and fair dealing in the interest of consumers.” Currently, there are separate standards of identity for yogurt, lowfat yogurt, and nonfat yogurt. Under FDA’s proposal, there would be a single standard of identity for yogurt. This standard of identity could be modified to produce lower-fat versions under 21 C.F.R. 130.10, which sets out requirements for foods named by use of a nutrient content claim (e.g., “low fat”) and a standardized term (e.g., “yogurt”).

"Natural" Food Outsells "Organic" Food in 2008

Nielsen Media Research, of Nielsen TV rating fame, has released its "Healthy Eating Report for 2008". "Although much is written about organics, products labeled 'natural' generate much higher sales," said a representative of Nielsen Media Research.

Read excerpts from the report.

The word “natural” on labels is regulated by the FDA and USDA and the term “organic” is heavily regulated by the USDA. However, the restrictions on the use of the word “natural” are far less restrictive (in the case of the FDA) or far more vague (in the case of the USDA), than those for "organic".

More on FDA and USDA regulations for "natural" on food labels.

Coke Sued over Vitamin Water -- Sugar!!

Center for Science in the Public Interest has sued Coca Cola over its promotion of Vitamin Water as "healthful".  In fact, the drink has 33 grams of sugar per bottle, about the same as a can of pop. From the CSPI News Release:

"Coke fears, probably correctly, that they’ll sell less soda as Americans become increasingly concerned with obesity, diabetes, and other conditions linked to diets too high in sugar," said CSPI litigation director Steve Gardner. "VitaminWater is Coke's attempt to dress up soda in a physician's white coat. Underneath, it’s still sugar water, albeit sugar water that costs about ten bucks a gallon." VitaminWater typically retails for about $1.49 for a 20-ounce bottle.

For more information:

FDA – CFSAN – Structure/Function Claims
http://cspinet.org/new/200901151.html

Text of the Federal Regulation
http://www.cfsan.fda.gov/~lrd/fr000106.html
The regulation deals with labeling in regard to the health benefits of nutrients within food.  This seems to ignore the health benefits of the food product as a whole.  While it may be true that a specific nutrient in a food is beneficial, those benefits may be overshadowed by harmful effects brought about by the food product as a whole.

Read the CSPI complaint against Coke alleging unlawful business practices, fraudulent business practices, misleading and deceptive advertising, untrue advertising, fraud, misrepresentation, which was filed on 1/14/09.
http://cspinet.org/new/pdf/vitaminwater_filed_complaint.pdf

Color additive ruling: cochineal extract and carmine must be labeled

Thanks to Ricardo Carvajal of FDA Law Blog for this one:

FDA has issued a final rule that requires declaration of the color additives cochineal extract and carmine in the ingredient statement on the label of all food and cosmetic products that contain those additives.  FDA has made no changes to the proposed rule that it published in January 2006.  The final rule is effective on January 5, 2011, but FDA states that it “will not object to voluntary compliance immediately upon publication of the final rule.”

So I had to know -- what is cochineal extract?  Not surprisingly it comes from something called a cochineal, which is an insect.  From Wikipedia:

This type of insect, a primarily sessile parasite, lives on cacti from the genus Opuntia, feeding on moisture and nutrients in the cacti. The insect produces carminic acid which deters predation by other insects. Carminic acid can be extracted from the insect's body and eggs to make the dye. Cochineal is primarily used as a food colouring and for cosmetics.

More: cochineal is used as a biological agent to control prickly pear cactus in Australia.  See North West Weeds for more information.