July 31, 2017

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Food Label Regulations Status – 2017 Update

2017 Semi-Annual Regulatory Agenda

The White House Office of Management and Budget (OMB) published its 2017 Semi-Annual Regulatory Agenda for each agency.

We’ve gone through the report and listings and highlight impacts to food labeling.

Background: January 30th, 2017, Trump signed an executive order requiring that for every one new regulation, two must be revoked.

The impact of this executive order can be seen in the recently published 2017 Semi-Annual Regulatory Agenda which is posted on Reginfo.gov by the OMB.

You can find current, long-term and inactive regulations.

Current Labeling Regulations

Proposed Rule Stage Food Labeling: Health Claims; Soy Protein and Coronary Heart Disease

Expected October 2017

FDA is proposing to amend its regulation authorizing the use of health claims regarding the relationship between soy protein and coronary heart disease on the label or in the labeling of foods.  Under the FD&C Act “health claims,” which characterize the relationship of a food to a disease or health-related condition, must be authorized by FDA before they can be used.  The science supporting this claim is not sufficient to meet the statutory standard for FDA authorization, but there is some evidence supporting a soy protein benefit on coronary heart disease that FDA would allow as discussed in its guidance documents: 1) FDA’s Implementation of Qualified Health Claims; Questions; and Answers and 2) Evidence-Based Review System for the Scientific Evaluation of Health Claims. Ref: 0910-AH43

Final Rule Stage Food Labeling; Gluten-Free Labeling of Fermented, Hydrolyzed, or Distilled Foods –

Expected October 2018

This proposed rule would establish requirements concerning compliance for using a “gluten-free” labeling claim for those foods for which there is no scientifically valid analytical method available that can reliably detect and accurately quantify the presence of 20 parts per million (ppm) gluten in the food 0910-AH00

Long Term Labeling Regulations

Updated Standards for Labeling of Pet Food

Expected TBD

FDA is proposing updated standards for the labeling of pet food that include nutritional and ingredient information, as well as style and formatting standards. FDA is taking this action to provide pet owners and animal health professionals more complete and consistent information about the nutrient content and ingredient composition of pet food products. 0910-AG09

New Animal Drugs: Updating Tolerances for Residues in New Animal Drugs in Food

Expected October 2018

FDA is proposing to revise the animal drug regulations regarding tolerances for residues of approved and conditionally approved applications for conditional approval of new animal drugs in food by standardizing, simplifying, and clarifying the determination standards and codification style. In addition, the Agency is proposing to add definitions for key terms. The purpose of the revision is to enhance understanding of tolerance determination and improve the readability of the regulations.  0910-AG17

Major Food Allergen Labeling for Wines, Distilled Spirits, and Malt Beverages

Expected TBD

Pursuant to the House Committee Report accompanying the Food Allergen Labeling and Consumer Protection Act of 2004 (Pub. L. 108-282), TTB will consider how to appropriately apply allergen labeling to beverage alcohol products. We will consider how allergen labeling for these products will operate within our existing labeling regulations and with FDA regulations. 1513-AB08

Inactive Labeling Regulations

USDA

  • National Organic Program, Organic Pet Food Standards 0581-AD20
  • National Bioengineered Food Disclosure Standard 0581-AD54
  • Product Labeling: Use of the Voluntary Claim “Natural” on the Labeling of Meat and Poultry Products 0583-AD30
  • Revision of the Nutrition Facts Panels for Meat and Poultry Products and Updating Certain Reference Amounts Customarily Consumed 0583-AD56
  • Labeling of Meat Food Products Derived From Calves 0583-AD63

FDA

  • FDA Current Good Manufacturing Practice in Manufacturing, Packing, Labeling, or Holding Operations for Dietary Supplements 0910-AB88
  • FDA Food Standards: General Principles and Food Standards Modernization 0910-AC54
  • FDA Label Requirement for Food That Has Been Refused Admission Into the United States 0910-AF61
  • FDA Current Good Manufacturing Practice for Outsourcing Facilities 0910-AH09
  • FDA Laboratory Accreditation for Analyses of Food 0910-AH31

 

 

 

July 28, 2017

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Sugar under attack again

Sugar is in the news on multiple fronts. It’s clear sugar is under attack.  Products with sugar will be scrutinized. Products labels will be read. Consumers will begin questioning their sweeteners more and more.

CSPI Refiles Lawsuit Alleging Coca-Cola and ABA Deceived Consumers on Health Risks Keller and Heckman LLP

“Center for Science in the Public Interest (CSPI), a consumer-advocacy group, filed a complaint claiming that Coca-Cola and the American Beverage Association (ABA) misled consumers regarding the health risks of consuming sugary drinks such as soda.  The lawsuit specifically takes issue with Coca-Cola and the ABA’s emphasis on “calories in, calories out” and exercise as the best ways to manage health…The suit also alleges that Coca-Cola purposefully misled consumers on the health risks of drinking soda by funding research that downplays the dangers of sugary beverages. more

Should soda with non-caloric sweeteners be taxed too? In Philadelphia and Cook County, that’s the case.  Food Navigator

“Proponents of sin taxes say that putting a levy on sugar-sweetened drinks may play a pivotal role in fighting obesity, diabetes, and cardiovascular disease. But two of the eight US locations that have passed such a tax—Cook County (Chicago) and Philadelphia —passed ordinances that tax beverages with non-caloric sweeteners as well.” more

Coca-Cola’s earnings, sales top Wall Street expectations with more healthy drinks on tap CNBC

“With a new chief executive at the helm, Coca-Cola on Wednesday reported earnings and revenue that topped analysts’ expectations. The beverage maker also issued a more upbeat earnings forecast for the full year.

Increasingly, shoppers are searching for Coke’s healthier options — low in sugar and free of carbonation — which fueled these results, though Coca-Cola posted another drop in profit as it’s still in the midst of completing a refranchising plan.” more

In short check your products, ask yourself…

  • What sugars and sweeteners do I have in my products?
  • What do consumers know and think about those sweeteners. What are the trends?
  • What do my labels look like now?
  • What will my labels look like if I reformulate?
  • What will my labels look like under 1993 or 2016 labeling rule?
  • If I stick with 1993 rules, what will consumers think when I switch to 2016 labels that must list added sugars separately?

May 5, 2017

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a single Cacao Pod picture

Fair Trade – Ethical Label Claims

What does it mean to be fair trade?

You can test your own understanding of fair trade.  Look at the four logos below from Fair for Life, Fair Trade USA,Fairtrade International, Rainforest Alliance . What is their percentage of ethical ingredients? If you need to cheat and see the answers…here’s the original Washington Post comparison “Your ethical chocolate might be only 20 percent ‘ethical’” .

Fair for Life LogoFairtrade International logoRainforest Alliance Certified Logo

Knowledge Bank’s take:  Providing consumers with choices that align to their food philosophies is just good business.  Certifications are good, but understand your risks.    Make sure your marketing team and more broadly your customers understand what the certifications mean.  Align and harmonize your romance copy to the certification’s meaning and not what you might think it might mean.  Ensure you have systems in place to document and manage your supply chain.

 

March 29, 2017

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Sports Bean by Jelly Belly food label

Food label lawsuit – Jelly Belly hit for “Evaporated Cane Juice”

Once again the food label matters; ingredient names matter; word choice matters.

Law360, March 28, 2017 — reports that “Jelly Belly Mislabeled Its Sport Beans Candy”

A group of consumers have hit Jelly Belly Candy Co. with a proposed class action alleging it deceptively labeled its Sport Beans candy products as containing “evaporated cane juice” instead of sugar after the U.S. Food and Drug Administration found the phrase was misleading. The suit was filed in San Bernardino California.

Knowledge Bank’s take – First, always consult your lawyer on legal matters.  Second, evaluate each food label to determine if you are using the term “Evaporated Cane Juice” and understand your situation.  Third, if needed, develop your action plan.

As we previously posted, the FDA has been clear. The FDA says labeling sugar as evaporated cane juice ” is false or misleading because it suggests that the sweetener is fruit or vegetable juice or is made from fruit or vegetable juice, and does not reveal that the ingredient’s basic nature and characterizing properties are those of a sugar.”

 

March 21, 2017

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Image of Corn a source of High-Amylose Maize Resistant Starch used by new qualified health claim

Getting FDA approval for a qualified health claim

The following article is reprinted with permission; and provides an overview of the clinical trial research necessary to make a qualified health claim on front of food package labeling.   Companies needing a competitive edge must conduct rigorous studies to get a qualified health claim approved by the Food and Drug Administration.

High-Amylose Maize Resistant Starch Health Claim Approved for Type 2 Diabetes 

The U.S. Food and Drug Administration (FDA) recently approved a qualified health claim which will enable food companies to include messaging on the packaging of products which contain high-amylose maize resistant starch (HAM-RS). Type 2 diabetes (T2D) is characterized by insulin resistance which, over time, leads to exhaustion of the insulin-producing cells of the pancreas. Substantiation of the qualified health claim was supported by eight clinical trials, one of which was completed by members of the MB Clinical Research team. In this study, overweight and obese participants (11 men and 22 women) were randomly assigned to received either 0 (control), 15, or 30 g/d HAM-RS for four-week periods, separated by a three-week washout. In men, insulin sensitivity increased with daily intake of 15 and 30 g/d HAM-RS, relative to the control (48% and 56%, respectively, p <0.05 for both vs. control). However, there were no significant differences in insulin sensitivity for women, relative to control. The FDA concluded that the totality of the evidence supports the following claims:

“High-amylose maize resistant starch may reduce the risk of Type 2 diabetes. FDA has concluded that there is limited scientific evidence for this claim.”

“High-amylose maize resistant starch, a type of fiber, may reduce the risk of Type 2 diabetes. FDA has concluded that there is limited scientific evidence for this claim.”

Comment: We are hopeful that the approval of this qualified health claim will stimulate more research evaluating the effects of fermentable dietary fibers on carbohydrate metabolism. There is consistent evidence from observational studies that indicate higher consumption of certain fibers, especially cereal fibers, is associated with lower risks for metabolic syndrome and T2D. Research is needed to more clearly define the characteristics of dietary fibers that are associated with these benefits and to elucidate the underlying mechanisms. Based on our work and that of others, we hypothesize the liberation of short-chain fatty acids during fermentation of HAM-RS is a mechanism for enhanced insulin sensitivity. Other mechanisms may be important as well, particularly alterations in the microbiome.

References:

U.S. Food and Drug Administration. RE: Petition for a Health Claim for High-Amylose Maize Starch (Containing Type-2 Resistant Starch) and Reduced Risk Type 2 Diabetes Mellitus (Docket Number FDA-2015-Q-2352-0023), December 12, 2016.

 

Maki KC, Pelkman CL, Finocchiaro ET, Kelley KM, Lawless AL, Schild AL, Rains TM. Resistant starch from high-amylose maize increases insulin sensitivity in overweight and obese men.  J Nutr 2012;142:717-23.

February 17, 2017

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Confused by? Best by – Use by – Sell by

The Grocery manufacturers association (GMA) releases new industry guidance on Product Date Labels.

GMA

The new voluntary initiative streamlines the myriad date labels on consumer products packaging down to just two standard phrases. “BEST If Used By” describes product quality, where the product may not taste or perform as expected but is safe to use or consume. “USE By” applies to the few products that are highly perishable and/or have a food safety concern over time; these products should be consumed by the date listed on the package – and disposed of after that date.

 

Source: Grocery Industry Launches New Initiative to Reduce Consumer Confusion on Product Date Labels

January 6, 2017

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ConAgra Foods dealt blow by ninth circuit in ‘natural’ lawsuit

A hotly-anticipated opinion by the US court of appeals for the ninth circuit in a high-profile false advertising case, contains bad news for defendant ConAgra Foods (now ConAgra Brands), but may prove to be of less significance to other food manufacturers, say attorneys.


Source: ConAgra Foods dealt blow by ninth circuit in ‘natural’ lawsuit

January 6, 2017

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Plant-based ‘milk’ letter reignites standards of identity debate


According to the National Milk Producers Federation – and 34 members of Congress who wrote to the FDA before Christmas – using the term ‘milk’ on plant-based beverages misleads consumers, harms the dairy industry and violates milk’s standard of identity (lacteal secretions from cows). But where does the FDA stand?


Source: Plant-based ‘milk’ letter reignites standards of identity debate

January 6, 2017

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Milan’s Supermarket of the Future is Worth A Look

 

If you think labeling is tough now, wait until you have fully interactive systems. This news report by Phil Liebert, gives us a glimpse into the future. Remember the “label” includes anything that describes your your product in the marketplace. This includes websites and other product information beyond whats printed in the label.  At KnowledgeBank, we think providing customers with transparent information, is a winning strategy that allows customers to find products that meet their own individual food philosophies.

Learn how to shop for groceries smarter, eat healthier, and live better. With new food product video reviews, recipes, food allergy information, grocery coupons, tips and deals, Phil Lempert alerts customers and business leaders to impending corporate and consumer trends, and empowers them to make educated purchasing and marketing decisions.


Source: SupermarketGuru – Milan’s Supermarket of the Future is Worth A Look

December 20, 2016

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FDA Approves Health Claim for Resistant Starch and Reduced Diabetes Risk


The U.S. FDA has approved a petition filed by Ingredion Incorporated, Westchester, IL, resulting in a qualified health claim that will enable food manufacturers to communicate the relationship between high-amylose maize resistant starch and a reduced risk of Type 2 diabetes on the packages of conventional foods.

Source: FDA Approves Health Claim for Resistant Starch and Reduced Diabetes Risk