flagyl pink eye

Food Regulation Archive

Proposed FDA Rule Will Revamp Nutrition Labels

April 4, 2014

by Gabriella Agostinelli

For the first time in two decades, the FDA has proposed significant changes to nutrition labeling. The agency’s proposed nutrition labels will affect all packaged foods except meat, poultry and processed egg products, which are regulated by the Department of Agriculture rather than the FDA.


Proposed Label

Proposed Label

The proposed changes include:

  • Serving sizes will be updated.

Serving sizes would more accurately reflect the amounts people actually eat, rather than what they should eat. The proposal modifies the serving size in about 17 percent of the 150 categories of packaged food. For example, a 20 oz. bottle of soda would constitute one serving, rather than the 2.5 servings currently listed. Ice cream servings would increase from half-cup to a more realistic one-cup serving.

  •  “Added sugars” will be incorporated into the labels.

After the 2010 Dietary Guidelines for Americans stated that intake of added sugar is too high in the U.S. population and should be reduced, the FDA has included a separate line on the label to alert consumers of any added sugars.

  • Calories from fat will be removed.

Studies now show that the type of fat matters more to our health than the number of calories from fat. Labels for unsaturated, saturated, trans and total fat will remain.

  •  Daily values for nutrients will be revised.

To better reflect current nutrition knowledge, several daily value estimates will change, including sodium and fiber.  For example, the agency may reduce the daily recommendation on sodium from 2,400 mgs to 2,300. 

  • Vitamin emphasis will shift.

Vitamins A and C will be replaced by Vitamin D and potassium, as many Americans are not getting enough of these important nutrients.

  • Key nutrition data will be highlighted.

The proposed label format emphasizes elements such as calories, serving sizes and Percent Daily Value, as they are vital in addressing current public health problems like obesity and heart disease.

  • For larger packages, a new dual column format would be required.

The agency has proposed “dual column” labels to indicate both “per serving” and “per package” calorie and nutrition information for larger packages that could be consumed in one sitting or multiple sittings.

 So far, reviews have been mixed regarding the value of these changes. Critics suggest that only a small portion of Americans actually pay attention to the proposed labels, which would cost the food industry an estimated $2 billion. Supporters of the proposed rule maintain that the changes will improve consumer awareness, incentivize producers to make their food products more healthful, and lead to smarter food purchasing decisions by consumers.

The proposal is open to public comment until June 2, 2014, and months will pass before the final rule is announced. Once a rule is finalized, food companies will have two years to put the changes into effect.

California’s Prop 37, GMO Labeling, Part 3

September 27, 2012

Lauren Handel is back today with further insight into the possible legal objections to California’s Proposition 37, the popular referendum on mandatory GMO labeling of food products. Once again, she puts policy and science debates to the side and examines just how challenging it will be for Prop 37 to successfully navigate our constellation of existing food laws. 

In addition to the First Amendment challenges Prop 37 that we covered yesterday, the opponents of the measure will seek to invalidate the law on the grounds that it is preempted by federal food labeling requirements.  Preemption is the constitutional principle that federal law trumps state law.  State laws may not conflict with federal laws.  Specifically with regard to food labeling, the Food, Drug, and Cosmetic Act (“FDCA”), Federal Meat Inspection Act (“FMIA”) and the Poultry Products Inspection Act (“PPIA”) all contain provisions expressly stating that they preempt conflicting state laws.

Opponents of Prop 37 have a strong argument that the law would be preempted by FMIA and PPIA to the extent it would regulate the labeling of meat and poultry products.  That is because FMIA and PPIA prohibit state labeling requirements for meat and poultry products  “in addition to, or different than” federal requirements.  Prop 37 would impose requirements “in addition to [and] different” from federal requirements because it would require labeling of genetically-engineered meat or poultry products whereas no such requirement exists in federal law.  In addition, Prop 37 would impose different requirements in direct conflict with federal law in that it would prohibit “natural” claims on minimally-processed meat and poultry products that would be permitted—and could even be pre-approved by USDA—under federal law.

In contrast, Prop 37’s requirements for labeling foods within the ambit of FDCA (nearly everything other than meat and poultry) probably are not preempted.  FDCA’s preemption language prohibits state labeling requirements that are “not identical to” federal requirements.  In interpreting this provision, courts have held that states may impose labeling requirements addressing issues not regulated by FDA.  Because FDA has not regulated the use of “natural” claims, many courts have held that states are free to do so.  The same analysis should apply to regulation of genetically-engineered food labels.  Because FDA policy does not require nor prohibit disclosures that foods are genetically engineered, Prop 37’s disclosure requirement (with respect to foods other than meat and poultry) should not be preempted.

Nevertheless, challengers may argue that Prop 37 is preempted because it would conflict with FDA ingredient labeling requirements.  A  recent decision of a federal court in California held that state requirements to disclose of genetically-engineered ingredients are preempted by FDA’s exhaustive regulation of ingredient listings.  That decision, however, does not apply to Prop 37 because Prop 37 would not require manufacturers to identify ingredients that were genetically engineered.  Rather, Prop 37 would require only a statement on the front or back of a package stating that a food is genetically engineered or has been produced with genetic engineering.

A somewhat better argument for preemption might be that, in requiring manufacturers to identify products as genetically engineered, Prop 37 would cause them to violate FDCA’s prohibition against making misleading claims.  The argument would be that a “genetically-engineered” label would mislead consumers into believing that the food is materially different than (and inferior to) a comparable product containing traditional ingredients.  While this argument may have some appeal in light of FDA’s position that genetically-engineered foods are no different than their traditional counterparts, FDA has stated (albeit in a draft guidance document) that simple, factual statements of the type Prop 37 would require—that a food is genetically engineered or contains genetically-engineered ingredients—are not likely to be misleading.  Although FDA’s guidance on this issue would not be binding on a court, it is some evidence that the agency would not consider the disclosure claims required by Prop 37 to run afoul of FDCA’s prohibitions against misleading claims.

–by Lauren Handel

Food Law and Why Practice Area Is Destined to Grow

August 22, 2012

As I proudly relayed earlier today, some colleagues of mine are putting together a Continuing Legal Education Course at Pace University School of Law in October. That is a good sign that the practice area we happy few call “Food Law” is growing and gaining legitimacy. Via Baylen Linnekin of Keep Food Legal and Reason, we have some firm indication that if the public has its way, more food laws and regulations will be headed to a specialized law office near you. Apparently, the public loves regulation in the food industry. I say “public” as in “general public”, regardless of political affiliation.

In his latest piece for reason, Baylen conducts an interview with Jayson Lusk, agricultural economist at Oklahoma State University and recent author of a recent  study, The Political Ideology of Food. Respondents to Lusk’s survey were most in favor of additional government action related to food safety, but quality, public health, and agricultural policies such as subsidies were other predominant concerns. Lusk found that this was true even among groups ideologically predisposed to disfavor regulation, such as libertarians. Key quote from Baylen’s  interview:

…libertarians, in fact, prefers less regulation on farm policy issues and less regulation on what I call “food quality and quality” issues. It is only “food safety” issues where the libertarians prefer more regulation. When I look specifically at what most of them said they preferred, it tended to relate to a desire to have more mandatory labeling of foods according to origin of production and use of genetic modification, cloning, irradiation, or nanotechnology. I can only speculate about why such preferences were expressed among libertarians, but perhaps it relates to a belief that labels promote “truth in advertising” or provide information needed to avoid deception in trade among food sellers and buyers.

We have a contentious political culture – no doubt –  but I find it interesting that despite the divisions the one thing everyone can agree on is more food regulation. I applaud the efforts of groups like Keep Food Legal, which strives for a regulatory climate more favorable to entrepreneurs and smaller scale producers. But if this study is accurate, or if the public’s inclination is indicative of a future trend, we could see more laws and regulations in the food industry that will occupy us Food Lawyers.

Americans Fed Beetles, NPR Scooped by Cracked.com

April 2, 2012

Under current federal food labeling laws, food processors can feed people ground-up beetles without having to tell them about it. Actually, they are required to disclose it on their labels, but they have to call it something that sounds innocuous.

You’ll often see “carmine” or “cochineal” on an ingredient panel, which are interchangeable names for a purple-looking dye made by processing the guts of Dactylopius coccus, a scaled cactus-parasite native to Mexico and South America. As reported by NPR last Friday, some conscientious Starbucks customers found out it was being added into their overpriced, fair trade fraps and are now understandably disgusted concerned.

Cracked.com did a substantially more revolting bit about cochineal in the food system four years ago, Number 3 on this list:

“Carmine is made, literally, from ground-up cochineal insects, which is just a more harrowing way of saying mashed red beetles. Because you’re dying to know more, the insects are killed by exposure to heat or immersion in hot water and then dried. Because the abdomen region that houses the fertilized eggs contains the most carmine, it is separated from the rest of the body, ground into a powder and cooked at high temperatures to extract the maximum amount of color.

Then, it’s added to that yogurt you ate this morning while lording your health consciousness over the guy in the cubicle next to you who had an Egg McMuffin.”

According to the USDA, using ground beetle-abdomen is perfectly legit, so long as the extracted beetle-juice is pasteurized. 21 CFR 73.100. Great, so eating it won’t kill us, but… it’s still beetles.

Federal regulation mandates that food manufacturers label this additive as either “cochineal” or “carmine” on the product ingredient panel. These are the only acceptable words that processors are allowed to use. In other words, if it goes into your product, you must use the designer name of the coloring instead of something accurate but unpalatable like ‘beetle-dust’. It is almost as if federal regulations require food processors to be disingenuous. Thanks to this sleight of hand, unless you were an entomologist, you’d probably breeze right over the ingredient label and never know you’re about to eat beetles. If we had a truly transparent food system, our own laws would force processors to call it “dried and pulverized beetle coloring” instead of some soft trade name. But of course that would make us think twice about eating that blueberry yogurt.

Food law will mandate sanitation (by mandating pasteurization) without ever addressing the issue of whether we should eat some things in the first place.