Last Updated on February 22, 2021 by Colleen

2-Step Call to Action: FDA’s May 22, 2020 Food Labeling Guidance

On May 22, 2020, the Friday before a 3 day holiday weekend, the US FDA issued new food labeling guidance relaxing food labeling laws that are important to know about if you have food allergies and intolerances to ingredients outside the US “top 8” and gluten (peanut, tree nuts, soy, milk, egg, wheat, fish, shellfish) or you are allergic to highly refined oils made from the top 8 allergens. The FDA did not seek any public input and the guidance is implemented immediately. It is, however, accepting public comment now. I am going to submit my comments in two separate communications. The first will ask the FDA to suspend the implementation of the guidance.

In the second, which I intend to post early this week, will address the specific changes I want to see in the guidance itself. (For more details on the new guidance prior to then, see my Facebook live video or my LinkedIn video). I’m getting fantastic information from all of you, so please keep the messages coming, In particular, I’m seeking anecdotes about people who are allergic to one type of food but not another (e.g. one type of mushroom or another) and about people who have reactions to highly refined oils made from the top 8 allergens (soy, peanut, tree nuts). Please reach out to me at info@zegofoods.com or through social media @zegofoods. Be sure to follow us on social media pages @zegofoods to stay on top of what we are doing.

I used to work on Capitol Hill writing legislation and the regulations implementing those laws. I’ve also seen how they are interpreted and misinterpreted by local governments and companies, and the damage misguided regulatory action can have. Food transparency is critical to the health and wellness of millions of people in America and around the world. If you would like to join me in this two-phase outreach to the FDA, here is some information and draft letters that may make save you some time. Again, if you have any questions, please reach out to me at info@zegofoods.com.

Call to Action

For those of you interested in taking action, there are several important things I want to stress based on my experience as a former legislative staff person for Cong. George Miller and as a former lobbyist for child nutrition.

What is the “ask?”

The first thing we want to do is have the FDA immediately suspend the new guidance to give us time to provide public comment.

What should I say?

Keep your ask simple and to the point. Include very basic information about you or your family so the reader understands why this important to you. But remember, the more words you write, the less likely they will read it all and understand what you want.

For now, resist the temptation to spend a lot of words on asking for existing laws to be changed (like adding a new allergen to the top 8 list). While it is very important that we keep trying to improve food transparency laws, those appeals can be made in different communication after we get past this situation.

Who should I contact?

Send letters via email and call the FDA and your representative in Congress immediately, as early this week as you can. It’s all very easy to do, and it’s your right to appeal to your government.

If you are nervous about making a call, don’t be. It’s their job to listen to you, even if you aren’t 100% eloquent! Comments you leave on Facebook groups, etc, will not get to these decision makers. You must reach out to them directly to be heard.

How do I email and call?

Reach out to both your senators, your representative in the House, and the FDA.

• You have 2 senators and 1 congressperson who represent you in Washington, DC. Find out who they are and how to call and email them here.
• For the FDA, I encourage you to email to ensure your will be recorded. You must include the D-1139 and the complete title of the document, which is as follows. “Temporary Policy Regarding Certain Food Labeling Requirements During the COVID-19 Public Health Emergency: Minor Formulation Changes and Vending Machines Guidance for Industry” Submit electronic comments to Lynn Szybist at Lynn.Szybist@fda.hhs.gov and via the FDA website (follow the instructions). All comments should be identified with the docket number FDA-2020-D-1139 and the complete title of the guidance in the request. I do not recommend submitting comments through regular mail. With work-at-home still in place in many federal agencies, mail may not be opened for some time. For call, use 1-888-723-3366. I will update this phone number for the FDA if I find there is a better one to use.

Calls: Calls are important. Say you are a voter living in the district. Keep it super short because most likely the staff person you speak to will ask you to email someone else in the office. It’s important to both call and email. (1) Calls are noticed more because they are harder to ignore. (2) Emails give you space to say what you want to but are more easily pushed aside or lost.

Email: Stay focused with a clear ask. Below is the letter I am sending on behalf of my family. I will also send one as the owner of ZEGO. I’ve adapted it to be a template you can use if you like. Feel free to copy and paste from it but do add in individual information about your family (while keeping it short).

____________________________________________________________________________________________

DRAFT LETTER TO CONGRESS

____________________________________________________________________________________________

Date:

To: The Honorable (fill in the full name of legislator)

From: Colleen Kavanagh, constituent in San Francisco, CA

RE: urgent request to suspend implementation of FDA May 22, 2020 guidance (docket FDA-2020-D-1139) until public comment can be made

___________________________________________________________________________________________

Dear Representative/Senator xxx:

I am writing to ask you to appeal to the FDA on my behalf to delay the implementation of its May 22, 2020 new guidance to loosen certain food labeling requirements so public comment can be taken.

This new guidance, “Temporary Policy Regarding Certain Food Labeling Requirements During the COVID-19 Public Health Emergency: Minor Formulation Changes and Vending Machines,” gives food companies permission to make certain changes to their products’ ingredients without notifying consumers in any way, even on the company website, product pages, or 3^rd party selling platforms like Amazon or Thrive.

My family has multiple food allergies and intolerances beyond the top 8 allergens and gluten recognized by the FDA. In our family, we juggle allergies and intolerances to dairy, gluten, tapioca, corn, soy and cane sugar. Food company transparency about ingredient changes, no matter how small, is of vital importance to me. Without exaggeration, for those who can have severe food reactions, even minor ingredient substitutions can be a matter of life or death.

The new FDA guidance was published on the Friday before the three-day Memorial Weekend holiday and is to be “implemented immediately,” without public comment.

The FDA asserts its authority to do so based on the Federal Register, Vol. 85 No. 58, of March 25, 2020 notice. That notice states the FDA does not need to take public comment prior to issuance of a Covid-19 public health-related change in guidance if public comment is “not feasible or appropriate.” But, the FDA’s reliance on this allowance has no merit.

Public Comment Is Appropriate.

1. Some of the allowances in the guidance could cause harm, or even be fatal, to my family and others who have a variety of food allergies and intolerances.
2. The guidance is poorly drafted and contains confusing and contradictory language that needs to be clarified.
3. No matter how the guidance is interpreted, it allows food manufacturers to make changes to ingredients in products that could harm some people without ever having to notify them in any way, like simply posting it on their website or reporting it to the FDA so the FDA can keep a public, master list of all the Covid-related changes industry-wide. The ability of a company and the FDA to communicate such information is not impacted by Covid-19.
4. This lack of transparency will impact health for several years because many shelf stable products made under it will have expiration dates 12-36 months out.

Public Comment is Feasible. Public comment can be taken easily through electronic methods and solicited quite quickly. The community of people whose health could be endangered by the new guidance is organized and connected. They can respond with speed. Furthermore, these consumers should be able to see the public comment of food companies so they have some idea which companies may be taking advantage of the new flexibility. This transparency is critical.

Two weeks of public comment could save lives. Will you help us get that by asking the FDA to suspend the effective date of this new guidance until we can respond and they can take our concerns into consideration? Working together with the FDA, we can help make any regulatory changes safer for our family and your other constituents with critical dietary restrictions.

Thank you for your time and attention to this important matter,

Name

email

Full Address

Ages of people in your family and their dietary restrictions

____________________________________________________________________________________________

Draft Letter to FDA

____________________________________________________________________________________________

Date:

To: FDA

From: Colleen Kavanagh, San Francisco, CA

RE: urgent request to suspend implementation of FDA’s May 22, 2020 guidance until public comment can be made

___________________________________________________________________________________________

I am writing to ask the FDA to delay the implementation of its May 22, 2020 new guidance to loosen certain food labeling requirements so public comment can be taken.

This new guidance, “Temporary Policy Regarding Certain Food Labeling Requirements During the COVID-19 Public Health Emergency: Minor Formulation Changes and Vending Machines,” gives food companies permission to make certain changes to their products’ ingredients without notifying consumers in any way, even on the company website, product pages, or 3^rd party selling platforms like Amazon or Thrive.

My family has multiple food allergies and intolerances beyond the top 8 allergens and gluten recognized by the FDA. In our family, we juggle allergies and intolerances to dairy, gluten, tapioca, corn, soy and cane sugar. Food company transparency about ingredient changes, no matter how small, is of vital importance to me. Without exaggeration, for those who can have severe food reactions, even minor ingredient substitutions can be a matter of life or death.

Your guidance was published on the Friday before the three-day Memorial Weekend holiday and is to be “implemented immediately,” without prior public comment.

You refer your Federal Register, Vol. 85 No. 58, of March 25, 2020 notice as giving the Agency that authority. That notice states the FDA does not need to take public comment prior to issuance of a Covid-19 public health-related change in guidance if public comment is “not feasible or appropriate.” The FDA’s reliance on this allowance has no merit.

Public Comment Is Appropriate

1. Some of the allowances in the guidance could cause harm, or even be fatal, to my family and others who have a variety of food allergies and intolerances.
2. The guidance is poorly drafted and contains confusing and contradictory language that needs to be clarified.
3. No matter how the guidance is interpreted, it allows food manufacturers to make changes to ingredients in products that could harm some people without ever having to notify them in any way, like simply posting it on their website or reporting it to the FDA so the FDA can keep a public, master list of all the Covid-related changes industry-wide. The ability of a company and the FDA to communicate such information is not impacted by Covid-19.
4. This new labeling flexibility and lack of transparency will impact public health for several years because many shelf stable products made under it will have expiration dates 12-36 months out.

Public Comment is Feasible

1. Public comment can be taken easily through electronic methods. Electronic communication is in inhibited  by Covid-19.
2. Public comment could be gathered in a timely manner. The community of people whose health could be endangered by the new guidance is organized and connected. Food companies also are capable of responding quickly.
3. There is a public health need for consumers to be able to have access to the public comments of food companies so they know which companies support and may take advantage of it. This transparency is critical.

The FDA is responsible for protecting and promoting public health. Let our community help you do that. Temporarily suspend implementation of your guidance and open up for two weeks of public comment. Let’s work together to keep the public safe.

Thank you for your time and attention to this important matter,

Name

email

Full Address

Ages of people in your family and their dietary restrictions

___________________________________________________________________________________________

Stay healthy, Colleen

Colleen Kavanagh is the founder and CEO of ZEGO. ZEGO is the first purity-transparent food company, making superfood products with traceable transparency designed to be safe for most all people to eat regardless of dietary restrictions like common allergies, intolerances or diabetes. ZEGO makes purity protocol gluten free oats, muesli, protein powder, Mix-ins trail mix and nutrition bars. All products are gluten free, peanut free, tree nut free, dairy free, soy free, sesame free, glyphosate free, lupin free, and sulfite free. ZEGO is certified as a B Corp and as Women Owned (WBENC).

 San Francisco, CA