December 18, 2018

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Congress says skip the “added sugars” on honey and maple syrup

Congress put a stop to misleading “added sugars” declarations on honey and maple syrup nutrition facts labels with the passing of the Farm Bill.  A product packaged as solely “sugar”, honey, or a syrup (like maple syrup or agave syrup) shall not be required to show a value for “added sugars”.  This overrides the FDA’s 2016 regulatory update and guidance language that mandated a value because these foods are used in consumer diets as a source of “added sugars”.  Industry consistently objected to this as consumers understood it meant that MORE cane or beet sugars were being added to Mother Nature’s honey and maple syrup creations.

The simple paragraph within the 2018 Farm Bill is easily missed with the heading: SEC. 12516. LABELING EXEMPTION FOR SINGLE INGREDIENT FOODS AND PRODUCTS.

IMPORTANTLY: Processed foods that include these sweet ingredients WILL BE REQUIRED to show “added sugars”. This declaration and the paper trail to show how the value was derived remain a part of the 2016 regulatory update.  The deadline for most companies to comply with the new Nutrition Facts format is barely 1 year away.

Special thank you to Riëtte van Laack of Hyman, Phelps & McNamara PC for putting this joy in today’s reading.

October 22, 2018

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Cultured cells as “meat & poultry” discussed by FDA & USDA/FSIS

Check those holiday menus–those traditional menu items may not be what you think in the future!

What is “meat” and “poultry”?  Join FDA and USDA/FSIS for a free 2-day webinar on cell-cultured meat and poultry.

October 23-24, 2018

The first day of the meeting will focus primarily on the potential hazards that need to be controlled for the safe production of animal cell cultured food products and oversight considerations by regulatory agencies. The second day of the meeting will focus on labeling considerations.

Representatives of industry, consumer groups and other stakeholders are invited to participate in the meeting. Attendees are encouraged to pre-register to attend the meeting. Pre-registration is available at the Meetings and Events page on the FSIS website.

Webinar and meetings will be held on Oct. 23 from 8:30 a.m. to 4 p.m. (EAST COAST), and Oct. 24 from 8:30 a.m. to 3 p.m. (EAST COAST) in the Jefferson Auditorium in the U.S. Department of Agriculture South Building, 1400 Independence Ave. SW, Washington, DC, 20250.

First day webinar link


December 16, 2016

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FDA OKs qualified health claim for resistant starch and diabetes

News that the US Food and Drug Administration (FDA) has approved a qualified health claim about high amylose maize resistant starch as a weapon in the fight against type 2 diabetes will start a much-needed conversation about the fiber, say experts.

By Elaine Watson+, 15-Dec-2016 /

Source: FDA OKs qualified health claim for resistant starch and diabetes



October 12, 2016

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Important Dates for Food Manufacturers

The FDA posted a reminder on key compliance dates. Here is a reposting of their message.


Why aren’t the compliance dates for the various nutrition initiatives that manufacturers have to meet more coordinated? Actually, they are. In summer of 2018, manufacturers will have to comply with key nutrition initiatives. The key dates are as follows:


  • On June 18, 2018, manufacturers must ensure that their products no longer contain partially hydrogenated oils for uses that have not been otherwise authorized by FDA.
  • On July 26, 2018, manufacturers with $10 million or more in annual food sales will need to comply with the new requirements for the Nutrition Facts label.
  • Also on July 26, 2018, vending machine operators with glass front vending machines will have to comply with all requirements of the vending machine labeling rule. FDA delayed the compliance date for calorie declaration requirements for certain food products sold from glass-front vending machines in part to be consistent with the compliance date for the new Nutrition Facts label requirements so that manufacturers can make changes to front-of-pack labeling for products they supply to vending operators at the same time that they make changes to the Nutrition Facts label.


How do menu labeling requirements impact packaged food manufacturers? The requirements for menu labeling largely affect a different segment of industry—restaurants and similar retail food establishments. We do not expect these requirements to have a great impact on manufacturers. Those establishments that are covered by the menu labeling rule must comply with menu labeling requirements by May 5, 2017.


What about the targets for sodium reduction that FDA is developing? The targets for sodium reduction that FDA is developing are voluntary so there will be no compliance date. However, we are recommending timeframes for companies that choose to implement the targets, once finalized. FDA has published for public comment draft voluntary targets for reducing sodium in commercially processed and prepared food both in the short-term (2 years) and over the long-term (10 years).


For More Information

August 1, 2016

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Expected Soon – New Dietary Ingredient Guidance

Natural Products Insider, is reporting FDA Expected to Release NDI Guidance for Dietary Supplement Industry.  “Former Sen. Tom Harkin, a Democrat from Iowa, described the 2011 guidance as “awful” and contrary to the intent of lawmakers who drafted the Dietary Supplement Health and Education Act of 1994.” As Brandon Griffin, comments and Knowledge Bank agrees – “our hunch is that timing [for new guidance] will likely fall on dates where an industry gathering is happening”

May 26, 2016

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Sugar by any other name is sugar.


Evaporated cane juice, is a popular ingredient in the clean label and natural foods movements. But as yesterday’s Food and Drug Administration (FDA) guidance points out (and rightfully so) sugar by any other name is still sugar.

This issue has been building for a long time; in 2009 the FDA issued a recommendation, but clearly that wasn’t enough because NPR was still reporting on evaporated cane juice in 2012.

It’s now 2016, What do you think?

Food and Drug Administration Guidance

The FDA’s view is that the term “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.

Should evaporated cane juice be considered sugar or is it juice?

Hopefully you did not have a Las Vegas wager on this ingredient naming.   FDA’s guidance is their approach to making rules. Your food—or supplement–labels should adhere to the rules or you risk FDA action or worse, a lawsuit.  The FDA has said juice is misleading and the result of evaporation is basically crystalline sugar….not something you pour into a glass as a beverage





May 20, 2016

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FDA Finalizes new Nutrition label rules.

The countdown begins.  You have two years and sixty-seven days to be compliant.  Manufacturers will need to use the new label by July 26, 2018. If you have less than $10 million in annual food sales, you have an additional year.

These changes affect both foods and dietary supplements.


The FDA finalized the new Nutrition Facts label for packaged foods to reflect new scientific information, including the link between diet and chronic diseases such as obesity and
heart disease. The new label will make it easier for consumers to make better informed food choices.


Source: Labeling & Nutrition > Changes to the Nutrition Facts Label

May 4, 2016

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New FDA Rulings soon in effect

ucm387542On April 29th, 2015, two new FDA regulations finally made it to the US Office of Management and Budget  for the next stage of regulatory review and to assign a financial burden to the regulatory impact on industry and the economy.



Normally the process can take months, but with Presidential elections looming, insiders expect new regulations to be pushed through quickly.


According to FDA these rules are expected to have a “…one-time cost to industry of labeling, reformulation, and initial recordkeeping” of  “$2.3 billion, with a small annual cost associated with recurring recordkeeping. The cumulative benefits over 20 years range, on average, from $21.1 billion to $31.4 billion, depending on the inflation scenario used.”



April 25, 2016

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Books on FDA Food and Supplement Label Regulations

Books on Food and Supplement Labels


There are a handful of books on FDA label regulations. But, we always recommend consulting the the FDA website first for the most up-to-date information.

Book ImageBook details

Food Labeling Compliance Review

4th ed, July 31, 2007 by James Summers

Food Law and Regulation for Non-Lawyers: A US Perspective

A Food Science Text Series, 2015th Edition by Mark Sanchez Esq.

Food Law in the United States Paperback

January 14, 2016 by Michael T. Roberts

Dietary Supplement Labeling Compliance Review

3rd Edition, May 31, 2004 by James L. Summers

“PRE-ORDERFood Regulation: Law, Science, Policy, and Practice

2nd Edition, November 21, 2016, by Neal D. Fortin

April 20, 2016

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FDA’s 2016 prioritizes rulings for FSMA, product labeling, GRAS, GMOs

FDA’s Center for Food Safety and Applied Nutrition is plowing ahead with an ambitious and wide-ranging agenda for the remainder of 2016 without pause after knocking out five final or proposed rules related to food safety and nutrition in just as many weeks.

Source: FDA’s 2016 food agenda prioritizes FSMA, product labeling, GRAS, GMOs