FDA Provides Temporary Flexibility for Nutrition Labeling of Certain Packaged Food due to COVID-19 Pandemic

From the FDA CFSAN updates.
FDA is issuing this guidance to provide restaurants and food manufacturers with flexibility regarding nutrition labeling so that they can sell certain packaged foods during the COVID-19 pandemic.   This guidance does not apply to foods prepared by restaurants. The guidance, due to the exceptional situation, has not been opened for preventive public consultation.
As a result of the COVID-19 pandemic, restaurants and food manufacturers may have food not labeled for retail sale that they wish to sell at retail.  For example, restaurants may have purchased ingredients that they can no longer use to prepare restaurant food and instead wish to sell to their customers.  To facilitate the distribution of food during the COVID-19 pandemic, the U.S. Food and Drug Administration today released a guidance document,  Guidance for Industry: Temporary Policy Regarding Nutrition Labeling of Certain Packaged Food During the COVID-19 Public Health Emergency, to provide restaurants and food manufacturers with flexibility regarding nutrition labeling of certain packaged food.
For restaurants that wish to sell packaged food to consumers directly, or to other businesses for sale to consumers, the FDA does not intend to object if the packaged food lacks a Nutrition Facts label, provided that the food does not have any nutrition claims and contains other required information on the label, including the following, as applicable:
  • a statement of identify
  • an ingredient statement,
  • the name and place of the business of the food manufacturer, packer, or distributor,
  • net quantity of contents, and
  • allergen information required by the Food Allergen Labeling and Consumer Protection Act.
For food manufacturers that have inventory on hand that is labeled for use in restaurants, the FDA does not intend to object to the sale of packaged food that lacks a Nutrition Facts label by food manufacturers, provided that the food does not have any nutrition claims and contains other required information on the label, including the following, as applicable:
  • a statement of identity,
  • an ingredient statement,
  • the name and place of business of the food manufacturer, packer, or distributor,
  • net quantity of contents, and
  • allergen information required by the Food Allergen Labeling and Consumer Protection Act.
Finally, if retail packaging for certain food products is unavailable, the FDA does not intend to object to the further production of food labeled for use in restaurants that is intended to be sold other than to restaurants until retail packaging is available. Although the guidance is being implemented immediately, it remains subject to comment according to the agency’s good guidance practices.
Separate from this guidance, FDA intends to work cooperatively with manufacturers for the remainder of the year regarding using updated Nutrition and Supplement Facts labels and will not focus on enforcement actions during this time.  FDA previously announced that it would do so for the first six months following the January 1, 2020, compliance date.

Japan – Updates about food allergen labeling

Today we publish the second guest post from our friends in Osaka, Label Bank ! (see link at the end of the article for more info)

On July 5, 2019, the CAA announced two critical amendments during the COCC Food labeling section meeting:

  • “Almond has been added to the list of foods recommended to use allergen labeling”, and
  • “Walnut has been designated as a food subject to mandatory labeling”

In fact, in Japan a periodic “National survey of state of health damage caused by immediate food allergies” is performed approximately every three years.

On May 31, 2019, the “report on survey and research business of food labeling related to food allergy” was posted on the CAA website (and corresponding to the fiscal year 2018): it showed an increase in the number of allergy cases for almond and walnut – compared to the previous reports from fiscal years of 2015 and 2012.

According to the part “Consideration and Conclusion” pertaining to the labeling of foods containing allergens and based on the allergy cases covered by the mandatory 7 items and/or recommended 20 items of specific ingredients are included, said 27 items were seemingly enough as a subject to control allergy food labeling in Japan.

That said, there are other allergy cases which are not related to those items, of which almond accounted the most twice in a row in the last surveys; actually even more than allergy cases usually reported for banana, cashew and sesame (n.b: those are currently part of the “recommended” list). Those results have drowned attention to the necessity to amend almonds to the recommended list for allergen labeling. Also, there is a sudden increase of allergic reactions to nuts, and for walnuts particularly.

Comparison of the allergy reaction cases for foods containing walnuts and almonds between the fiscal years 2012, 2015, 2018 based on the Discussions

Substance that causes allergy Classification Fiscal year of Correspondence
2012 2015 2018
Walnut Number of immediate allergy cases 40 74 251 Consideration to make labeling mandatory (*)
Number of shock cases 4 7 42
Almond Number of immediate allergy cases 0 14 21 Consideration to add to the recommended items (*)
Number of shock cases 0 4 1

(*)“Allergen labeling” according to the Food Labeling Standard’s aim of alerting allergic consumers to certain foods or ingredients in order to prevent any health damages.

Specific ingredients subject to allergen labeling were (before the addition of almond) classified as below under “specific ingredients (7 items of mandatory labeling)” and “those equivalent to specific ingredients (20 items of recommended labeling)”.

Specific ingredients, etc. Reason Mandatory labeling
Specific ingredients Shrimps, crabs, wheat, buckwheat, eggs, milk, peanuts Ingredients with an especially high necessity of labelling considering the number of occurrences and severity of cases Mandatory labeling
Those equivalent to specific ingredients Abalones, squid, salmon roe, oranges, cashews, kiwis, beef, walnuts, sesames, salmon, mackerel, soybeans, chicken, bananas, pork, matsutake mushrooms, peaches, Japanese yams, apples, gelatin Ones which continuously cause certain numbers of cases and people to present severe symptoms but less than specific ingredients Recommended to label

(Voluntary labeling)

 

Reminder regarding allergen labeling: In terms of labeling, there are two methods accepted in Japan, according to the following examples:

individual labeling: example

Ingredients: potato, carrot, ham (containing egg and pork), mayonnaise (containing egg and soybeans), hydrolyzed protein (containing beef, salmon, mackerel and gelatin) / seasoning (amino acid, etc.)

Collective labeling: example

Ingredients: potato, carrot, ham, mayonnaise, hydrolyzed protein / seasoning (amino acid, etc.), (partially containing egg, pork, soybeans, beef, mackerel and gelatin).

(n.b: “individual” labeling should normally be used when there is enough labeling space to allow so)

The enforcement of walnut labeling as a mandatory allergen might become effective in two to three years based on the following two discussion points:

  • It is necessary to check if this increase in the number of cases is temporary

  • If walnut is designated as an item subject to mandatory labeling, it will become necessary to develop a testing method and evaluate validity from the viewpoint of securing enforcement

Meanwhile, almonds have already been amended to the recommended labeling items and enforced as of September 19th, 2019.

For manufacturers who used to display the 27 items (recommended and mandatory labeling) on their products, it is now necessary to add an entry of “almond” from the specification’s management phase.

Finally, please consider the following critical point:

In many foreign labeling systems, “walnut”, “cashew”, “almond”, etc. are labeled as “Tree Nuts” without further details; therefore when ingredients for use or food products are imported from overseas to Japan, this amendment needs to be seriously taken into consideration and necessary adjustments done to the specifications for instance.

We also recommended to check the CAA material, “About food labeling for foods containing allergen” on the COCC website ahead of establishing your new process/projects for the Japanese market.

CAA: Consumer Affairs Agency

COCC: Cabinet Office Consumer Commission

More about Label bank:

Label bank is company specialized in all services (formulation and label review, development, regulatory consulting, databases) related to the labeling of food product for the Japanese market.

Learn more here! https://label-bank.com/