May 9, 2018

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FDA formally sets Nutrition Facts & Supplement Facts compliance date of 1/1/2020

May 4, 2018, the FDA has announced:

 

U.S. Food and Drug Administration formalized the new compliance deadline to update the Nutrition Facts and Supplement Facts labels as January 1, 2020 for large manufacturers (and January 1, 2021 for small manufacturers). On that date, all labels must be applied to retail food and dietary supplement packages with the most recent regulatory updates for nutrition values and formats. The original compliance date was July 26, 2018 (or 2019) which was two years after the regulations were announced on May 26, 2016. [Hence the confusion whether the “new” regulations are 2016 or 2018 “versions”!] The extension had been mentioned by FDA but not formalized until now. “Large” manufacturers is set by FDA as those with $10 million or more in annual (global) food sales while “small” manufacturers means those with less than $10 million in annual food (global) sales. The agency published a proposed rule

 

The approximately 18-month extension is to help companies gather more information and to provide sufficient time to also add the required label disclosure of genetically engineered content announced today by the USDA. The transition will take many person-hours to adapt to the new reference serving sizes, document added sugar content, reformulate if manufacturers want to keep fiber claims, and a host of other formatting changes that the software databases have not accommodated.

 

The FDA is also committed to ensuring that all manufacturers have guidance to help implement the required label changes by the upcoming compliance dates. A full list of Nutrition Facts-related guidance documents is available on the FDA website.

For Additional Information:

May 9, 2018

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Federal Organic and GMO labeling rules proposed by USDA

 

The United States Department of Agriculture released its proposed rules for declaring “bio-engineered food ingredient” content on most foods that are not organically certified. The required disclosure will a federally mandated message rather than a warning, as is the case of with high risk products.

 

Industry and consumers only have until July 3, 2018 to make comments to the proposed rules–with no hope of an extension. USDA has set compliance dates to coincide with the FDA’s new nutrition facts and supplement facts label updates: January 1, 2020 (or 2021 for small manufacturers).

 

Comments are requested by the USDA regarding which disclosures are most suitable and if “TWO pre-approved lists of agricultural crops” make the most practical sense for designation of “b-e” foods and “b-e” food ingredients. The lists would be updated periodically and USDA is seeking comments on this practicality, too.

 

Comments may be submitted online through the Federal eRulemaking portal www.regulations.gov beginning Friday May 4. Comments may also be filed with the Docket Clerk, 1400 Independence Ave., SW, Room 4543-South, Washington, DC 20250; Fax: (202) 690-0338.

The deadline for comments is July 3, 2018

 

The USDA is proposing disclosures on packages –similar to the National Organic Program regulations–in the form of:

  1. logos,
  2. phone numbers that may receive text messages,
  3. electronic codes, or
  4. a designated phrase

The disclosure will not use the popular terms “Genetically Modified Organism” or “GMO”. Rather the USDA believes “bio-engineered” is a more realistic  term to comply to the law signed in 2016. This was the federal law enacted to avert a state-by-state patchwork of GMO-labeling laws.

 

 

The National Bioengineered Food Disclosure Standard Law was enacted by Congress on July 29, 2016. The proposed rule previewed in the May 3, Federal Register.

March 20, 2018

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Kombucha lawsuits highlight risk for new products

The recent FoodNavigator article “Health-Ade lawsuit highlights continuing area of legal vulnerability for kombucha makers: sugar and alcohol levels…”  highlights the risks for kombucha makers.  Their article does a good job of covering the issues from the Bayol v. Health-Ade LLC et al case filed March 6th in Northern California against Health-Ade LLC and Whole Foods Market California, Inc.

 

The lawsuit simply says (1) the alcohol level of the fermented beverage routinely exceeds 0.5% alcohol, and thus should be classified as an alcoholic beverage.

However we have seen a similar class action lawsuit – Millennium and Whole Foods agreed to pay $8.5Million in a class action lawsuit for mislabeling the GT Kombucha as a non-alcholic drink.

 

This two cases highlight, the inherent risks when entering new product categories.  Companies should look at their entire portfolio of products and evaluate their risk. Products in new product category have greater risks.  New product categories have the greatest potential “known unknowns” – i.e. we would expect that because their new categories, we don’t know everything about them.

 

 

January 22, 2018

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Do-it-yourself Guide to Organic Certification Fact-Checking

Shoppers buy from farmers markets to  support local businesses and farms, and buy the fresh organic produce and home made products.

But just because the farmer says its organic doesn’t mean it is organic, especially since food fraud is on the rise.  (See Two Huge Cases of Organic Food Fraud)

Even Congress is looking to fund the USDA to fight fraud.

So what is a local consumer to do?

A colleague brought to our attention this wonderful consumer Farmers Market Organic guide for  do-it-yourself verification of the Farmers Market sellers’ claims. (see also Cornucopia’s posting)

 

 

November 2, 2017

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“Local” — “Naturally” the next big fight?

Kelley Drye & Warren LLP, “Ad Law Access” bring us an article “Local” Means Something, but What?

 

According to BakingBusiness, “A jury in the U.S. District Court for the District of Utah, Central Division, on Oct. 6 awarded Bimbo Bakeries USA $2,105,256 after determining the company suffered damages from trade secret misappropriation and false advertising.”

 

The lawsuit dates back to August 2013 — US Bakery’s Grandma Emilie’s bread was too similar to Bimbo Bakeries USA’s [BBU] Grandma Sycamore’s bread. US Bakery had acquired the Grandma Emilie’s brand as part of its acquisition of certain assets of Hostess Brands, Inc.” BBU filed suit for trademark infringement, trade secrets misappropriation, false designation of origin, and false advertising.

 

Although the $2.1M award covers many areas, the suit alleged “the US Bakery’s “Fresh. Local. Quality.” tagline was false in Utah because U.S. Bakery neither maintained a baking facility in Utah nor contracted with a Utah facility to manufacture its products.” [Baking Business]

 

“The jury attributed over $8 million in profits to the false advertising and awarded over $2 million in total damages (including the trade secret claims). Because the Special Verdict form simply asked for “Yes” or “No” responses, we don’t have any insights into the analysis or a clear answer as to what “local” means.” [Ad Law Access]

 

In other words, “Local” joins “Natural” and other ill defined words, fully exposed for to private lawsuits.

October 24, 2017

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Stay Alert to Wrigley’s relaunch of Caffeinated Alert Gum

Perhaps you have seen the news:

 

After 4 years, caffeinated gum relaunches to the public.  Certainly the military dispenses caffeinated gum to its troops, but health risks and concerns are yet to be tested.  Cleary with the FDA on the sidelines and without a formal guidance, Mars Wrigley is taking a calculated risk.

 

The FDA through policy and regulation, has defined “Energy” as coming from  “carbs, fats, and protein.”  Consumers of central nervous system stimulants like caffeine, experience effects as a boost in  “energy”.

 

More over caffeinated gum that “confers energy to a human” enters the grey area, and becomes a questionable structure/function claim. This is a particularly interesting situation for FDA enforcement because gum is not a significant source of carbs, fats or proteins.

 

In all cases, develop your business strategy first, and consider all the risks.  For most companies without the Mars Wrigley resources,  we expect them to choose a  “wait and see what happens strategy.”  Only for the most fearless entrepreneurs with absolutely nothing to loose (i.e. no existing brand, not sales, no reputation) might try and carve out a small niche, and even then you might ask why enter a market that’s decreasing 4% a year. [“U.S. gum sales declined 4% in the first half of 2017, according to IRI data reported by Food Navigator-USA. While Wrigley dominates the category by a wide margin — owning 72% share”]

 

 

September 15, 2017

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The Scott Gottlieb Ooops Tweet

Dr. Scott Gottlieb, the new FDA head, is creating confusion about the UPDATED Nutrition Facts compliance date.

 

Food Navigator broke the story and well worth the read.

 

He spoke at a politico summit and suggested one date…then tweeted a different date.  Once the date is officially published in the Federal Register, then we will have a new target.Scott Gottlieb, The 23rd Commissioner of the U.S. Food and Drug Administration, tweeted an oops.

….this hour’s thinking is that the new date is 18 months out….mid-2019.

This would likely coincide with the required disclosure of genetically engineered ingredient content on foods and supplements.

Knowledge Bank’s next courses for labeling and Nutrition Facts update are next week! http://knowledge-bank.net/training/

 

The key takeaway  — “TWEETS” are like “water cooler” gossip.    Tweets and stories must be carefully considered and suspect until proven otherwise.  Tweets are not “legal” announcements of regulations.  The Federal Register remains the only way a regulation can become official.  Even the eCFR (Electronic Code of Federal Regulations) states “It is not an official legal edition of the CFR.”  Only the printed Federal Register remains the official mechanism.

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.