Last Updated on January 23, 2021 by Colleen

What’s going on:

On May 22, 2020, the U.S. Federal Drug Administration (FDA) issued new temporary policy guidance giving food companies experiencing supply chain problems due to Covid-19 the flexibility to change the ingredients in their products without changing their labels, within certain parameters.  

Click here to download a copy of the guidance. 

What’s good about the FDA’s new guidance:

1. The FDA specifically says none of the top 8 allergens or gluten can be used as substitutes for other ingredients.

2. The FDA does recognize that there are other allergenic foods (top 9-14 as recognized in other countries).

3. The FDA recognizes some people may have non-allergy sensitivities or intolerances to other foods or artificial ingredients or ingredient derivatives.

4. The FDA is accepting public comments even though the guidance is already implemented. There is still an opportunity to persuade the FDA to change the provisions in the policy to better protect public health.

What’s not good about the FDA’s new guidance:

1. The FDA does not define what a valid Covid-19 disruption to the supply chain is. Companies can make this decision without any transparency as to why.

2. The FDA does not require companies making off-label substitutions to notify consumers in any way, even on their website.

2. The FDA is not approving or tracking changes, let alone keeping a master database of all product changes.

4. The FDA issued this guidance on the Friday before a 3-day holiday weekend and made it immediately enforceable, without taking and considering public comment.

It is our right and responsibility as individuals and companies to petition our government.

 

It is the responsibility of everyone who needs or wants transparency in our food supply to write to the FDA and register their public comment on this new guidance.

Your comments need to be specific, factual and provide suggestions for improvement. Submitting an official public comment to the FDA the most important thing you need to do to change this new policy guidance.

In the box below, we have information to make it easy for you to submit comments to the FDA. 

• See ZEGO’s full public comments pasted at the end of this blog and email us with any questions at info@zegofoods.com.

  [Feel free to use ZEGO’s comments in part or in full, no need for attribution or quotation marks. Also, if you are too busy to write much on your own, it is perfectly fine to write a quick intro and say that you support the changes asked for by ZEGO in its May 26, 2020 submission. Our comment tracking number you should refer to is:

  kau-12dx-ah69

• Submit your comments through this direct link: https://beta.regulations.gov/document/FDA-2020-D-1139-0009  You will receive an email confirmation to confirm the submission went through.

• Write of your concerns to your Senators and representative in the House (see yesterday’s blog if you need info on how to reach them).

We are all in this together, and we must fight this together. Let us know how else we can help.

Stay well,

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).

LEARN MORE ABOUT ZEGO

SHOP ZEGO PRODUCTS

Date: May 30, 2020

Re: Public Comment, edited 5/30/20

From:  Colleen Kavanagh

CEO and Founder of ZEGO LLC

912 Cole Street #294, San Francisco, CA 94117

415.706.8094

Docket:  FDA-2020-D-1139

Title: Temporary Policy Regarding Certain Food Labeling Requirements During the COVID-19 Public Health Emergency: Minor Formulation Changes and Vending Machines Guidance for Industry May 2020

I am the founder of ZEGO, and my family and I also have dietary restrictions relating to gluten, milk, soy, tapioca, peanuts, and corn. Earlier in my career, I worked as a legislative aide on Capitol Hill, where I focused on child nutrition program laws and regulations.

I started my company, ZEGO, to improve the nutrition value of our food so people can be their best selves and provide support for their loved ones and our planet. We make packaged breakfast and snack foods designed to meet nearly all health-related dietary restrictions, including food allergies and intolerances. The cornerstone of our company and consumer advocacy is transparency. Consumers have a right to know what is in their food.

Many people need to restrict their diet to stay healthy, even to stay alive, and they cannot control their health if they do not have clear information on the food they are eating. This is not just true for the top 8 or even top 14 allergens. Consumers have documented allergies to hundreds of foods and many people experience negative reactions to natural and artificial ingredients. Though I understand why some companies are asking for limited flexibility in labeling due to Covid-19 related supply chain issues, the guidance the FDA published May 22, 2020, needlessly endangers lives by giving far more flexibility than is needed and not requiring meaningful notice to customers.

The FDA should make the following changes to its guidance to help it meet its charter of protecting consumer health:

1. Immediately suspend this guidance until public comment can be taken and considered, and ambiguities and contradictions in the document can be reconciled (see below). This temporary guidance has already shaken consumer confidence in US made products and is harming the food industry as a whole, regardless of whether the company intends to change their ingredients. Since the guidance was published on May 22, ZEGO has been fielding a flood of emails and calls from customers asking us if we are making any off-label changes to our products.
2. Define or give examples of what a legitimate Covid-19-related supply chain issue is to prevent companies from making changes that are not truly necessary.
3. Make it mandatory that companies post any substitutions to ingredients that are not reflected on the product label on their website in prominent locations, including the affected product’s page and in a separate stand-alone page summarizing all product ingredient substitutions for the brand.
4. Require companies report any substitutions they are making to ingredients not reflected on their label to the FDA, and explain why they believe the substitution will not cause any safety or health concerns.
5. Commit that the FDA will maintain a searchable list of all ingredient substitutions not reflected in product labels so consumers can easily find the information they need without having to navigate numerous company websites.
6. If you are not going to require numbers 2-5 above, do not allow substitutions at all. The danger to consumers is too high. It is also harmful to the entire food industry because allowing secret off-label substitutions will sew distrust (and already is) in US made products for years to come.

My specific comments are enumerated below.

PREFACE: PUBLIC COMMENT

The FDA asserts obtaining public comment prior to issuing this guidance was “not feasible or appropriate” (21 CFR 10.115(g)(2)). The flexibility this guidance gives food companies regarding substitutions could endanger the lives of thousands of people with food allergies and intolerances outside of the top 8 allergens. The FDA’s charter is to protect public health and it is appropriate to get public comment when the guidance could harm someone’s health or even take their life.

Since we do not have a life-threatening food shortage in the US, nor is one anticipated to be caused by a lack of labeling flexibility for ingredient substitutions on packaged food, it is inappropriate to prioritize flexibility for the food industry over the health and lives of people with these allergies and intolerances.

The FDA must immediately suspend this guidance until public comment is considered.

INTRODUCTION

Paragraph 1: “The FDA plays a critical role in protecting the United States from threats . . . “

• Among the threats in the United States the FDA needs to protect the public from are health dangers caused by inaccurate labeling. Certain foods can cause life-threatening allergic reactions or otherwise harm health. The FDA is needed to protect the public from this health threat even during a pandemic. For this reason, the FDA should take public comment into consideration BEFORE issuing any new guidance such as this.

Paragraph 2: Duration of the effect of the new guidance.

• Because many manufacturers buy ingredients in large lots and because some products have a long shelf life, the uncertainty this guidance inserts into the accuracy of US product labels likely will last 3-4 years. For this reason, the FDA should take public comment before issuing any new guidance such as this.
• The FDA should consider the negative effect this guidance could have on US food exports to other countries. Many other countries, as noted in your guidance, have more comprehensive rules around allergens than the US. Those countries could impose restrictions on US imports produced under this labeling flexibility.

BACKGROUND

Paragraph 2:

“Thus, it is fundamental that the labeling flexibilities as set out in this guidance remain in place only as long as needed to help ensure an adequate food supply during and after the pandemic.”

• The FDA should specify what food supply shortages it is addressing or anticipating with this new guidance. Any allowances should be granted on an as-needed basis for specific ingredients instead of issuing a blanket approval of all changes a company self-declares as necessary.

Paragraph 3:

“As a result of the COVID-19 pandemic, the food industry has informed us that there are supply disruptions or shortages for some ingredients and, as a result, manufacturers will need to make formulation changes, such as omissions or substitutions of minor ingredients, in the manufacturing of some foods.”

• Omissions and decreases in proportion of ingredients, which are less likely to pose risk to public health, should be separated from the discussion of substitutions, which can cause a significant risk to people allergic to the ingredient being used as a substitute.
• The FDA should be transparent about which companies are asking for this new flexibility and what shortages are being experienced or anticipated. By making this guidance immediately effective without prior public comment, consumers may never know which companies support this substitution flexibility, and thus, more likely to take advantage of it.

DISCUSSION

Paragraph 2:

“. . . we recognize that the COVID-19 pandemic is having a substantial impact on food supply chains . . .  .”

1. Not all supply chains are being significantly impacted by Covid-19. Given the potential danger to health this new guidance presents for some consumers, it is critical to narrow any labeling flexibility to the specific ingredients meaningfully impacted by Covid-19 supply chain disruption.

“. . . we recommend that manufacturers use alternative ways, such as posting information to their website or through point of sale labeling, to communicate to consumers any changes . . .  .” (emphasis added)

2. Notification by brands for ingredient substitutions must be required, not recommended. There is no reason related to Covid-19 that would prevent a company from posting ingredient changes on its website, product pages and 3^rd party selling platforms.

Food companies are constantly updating their websites and spending money on communicating with customers. Even during the pandemic, food companies are posting daily on numerous social media platforms, like Facebook, Twitter, Instagram, Pinterest, Tiktok, or IGTV. They have the resources to update their websites and 3^rd party selling platforms like Amazon.

It is true companies could choose to inform consumers of ingredient changes on their websites and 3^rd party platforms on their own but it is not assured they will since the FDA is not requiring them to do so. And, by not requiring notification, the FDA is unnecessarily creating years of fear and chaos in the marketplace and threatening the health and lives of people who have any one of hundreds of food allergies not included in the US “top 8” of peanut, tree nuts, soy, wheat, dairy, egg, fish, and shellfish as well as gluten.

3. Manufacturers must be required to have meaningful, accessible notification of ingredient changes on their website, on both the product’s page as well as a summary page with all label changes made by the brand under the flexibility given in this guidance. This information should include identifying information the consumer needs, such as product name, UPC, and lot code. This should also be accessible on the appropriate product page.
4. Manufacturers must also provide notification to 3^rd party sellers and platforms.
5. Manufacturers must be required to notify the FDA of any change and with appropriate identifying information.
6. The FDA must maintain a publicly accessible and searchable master document on its website of all brands’ products with ingredient changes being made under this guidance with the products’ identifying information such as UPC and lot code.

GENERAL FACTORS FOR FORMATION CHANGES DURING THE COVID-19 PANDEMIC

Paragraph 1:

“FDA does not intend to object to the food industry making certain temporary and minor formulation changes without making conforming label changes when there are supply disruptions or an ingredient shortage exists as a result of the COVID-19 pandemic.”

1. The FDA needs to stipulate what an acceptable use of this flexibility is. What is a defined as a supply disruption due to Covid-19? If a company’s current supplier is simply out of an ingredient but another supplier is readily available at similar price, this should not be considered a supply chain disruption worthy of making an ingredient change that could harm the health of some consumers.

“For purposes of this guidance, minor formulation changes should be consistent with the general factors listed below, as appropriate: • SAFETY: the ingredient being substituted for the labeled ingredient does not cause any adverse health effect(including food allergens, gluten, sulfites, or other ingredients known to cause sensitivities (see section C.2.a) in some people, for example, glutamates);” (emphasis added)

• This section is dangerously worded. The term “food allergens” should be defined and a more examples of “other ingredients” should be provided to inform better both companies and consumers. Even though the top 8 allergens account for 90% of food allergies, it is well-documented that hundreds of foods can and do cause allergic reactions.
• It is important the FDA include language in the guidance educating or reminding food companies that any ingredient change could have a negative health impact on someone allergic or intolerant to the substitute and thus should be done only as a last resort and with full disclosure.

1. Temporary Flexibility for Labeling Requirements During the COVID-19 Pandemic
   1. Reductions and Omissions. (no comment)
   2. Substitutions of Minor Ingredients at Less Than 2 Percent“ . . . as long as there are no safety or allergen concerns introduced.”
      • The stipulation of “less than 2%” does not protect people allergic to the ingredient being used as substitute. Allergies can be triggered by as low a level as a few parts per million, depending on the food and the person’s sensitivity and circumstance.
      • Because consumers may be allergic to any number of hundreds of foods, it is likely any substitution could cause an allergic reaction in the affected population. The FDA needs to include a clear statement alerting companies that any substitution could cause an allergic reaction. It needs to tell companies to avoid substitutions if at all possible and to clearly notify the public about any substitutions made.
      • Substitutions should not be given the same flexibility as reductions and omissions because the substituting ingredient could harm the health of people allergic to that food.
      • The FDA refers to “allergens” in numerous places in the document without specifying which allergens. When referring to the top 8 or 14 allergens, the document should specify those allergens listed in parentheses.

1. Avoidance Considerations

The FDA makes an important point in this section, recognizing there are food allergies and intolerances beyond the US recognized top 8. To protect consumers,

1. this subsection must be subsumed in the section above it as a second paragraph and the subtitle removed;
2. the second sentence of the that paragraph should read, “There are also other foods and ingredients . . . .), and

• in the third sentence of the that paragraph, the phrase “should avoid substitutions” must be changed to “must not make substitutions.”

1.  Examples of Substitutions of Minor Ingredients

Flavors and Spices

“Substitution of a flavor that poses an allergenic risk without a corresponding label change would not be appropriate. For example, some flavors may contain protein from allergens such as milk or peanut. Undeclared substitutions of different spices or changes to the proportion of spices would generally not be a concern if there are no allergens or other spices added that are known to cause sensitivity, such as sesame or mustard.”

We applaud the FDA for acknowledging and alerting companies that sesame and mustard pose health risks to some people and are not allowed as substitutions under the guidance. This section, however, is inconsistent with other sections of the document that allow for sesame and mustard to be substituted in as ingredients and do not require public notice of the change in any way. The FDA must require meaningful notice of any substitutions made under this guidance.

Colors

Some consumers are sensitive to certain dyes. Companies should be required to notify consumers of any color changes not listed on the label.

Acids

Some consumers are sensitive to certain acids. For example, people sensitive to corn need to avoid most citric acid. Companies should be required to notify consumers of any acid changes not listed on the label.

3. Substitutions of Different Varieties of the Same General Ingredient That May be Present at Greater Than 2 Percent

Varieties of the Same Ingredient

“However, some manufacturers may choose to specify certain varieties in their ingredient list instead of using a general term (e.g., declaring “Habanero peppers” instead of just “chili peppers” in the ingredient list). In this situation, FDA does not intend to object to certain temporary substitutions of similar ingredients without corresponding labeling changes, even if the specific variety is declared in the ingredient statement.”

Some people may not be allergic to habanero peppers but they are allergic to jalapeños, just as they may be allergic to one legume but not another, like peanuts v. peas. These consumers rely labeling accuracy to keep themselves safe.

Fats and Oils

“FDA does not intend to object to temporary substitutions without a label change of different fats or oils when the fats or oils are not prominent ingredients,7 the oils are highly refined, the substitutions do not pose an allergenic risk, the replacement fats or oils are from the same category of vegetable, animal, or marine oils, and the oils have a similar fatty acid profile to minimize the impact on the nutritional profile. For example, substitution of canola oil for sunflower oil may be appropriate without a label change (both are vegetable sourced and have similar fatty acid profiles) (emphasis added)

Some consumers are allergic to certain plant-based oils but not others. For example, in a product that has canola oil on the label but sunflower is substituted, people with sunflower allergies can have an allergic reaction.

4. Geographic Origin

“Some foods may voluntarily provide the geographical origin of certain ingredients. FDA does not intend to object to temporary substitutions of similar ingredients of different origin if the substitution is not for the food itself. For example, if a food states that it is made with “California raisins” and the manufacturer needs to substitute raisins from another domestic or international location, FDA does not intend to object.”

This section is a good example of why the FDA needs to add detailed information about what constitutes a Covid-19 related supply chain disruption. Companies could easily take advantage of this section to shift to cheaper overseas ingredient sources even though higher quality domestic sources are available. Some consumers who need to be very careful to keep their toxic load low, and those who simply want to stay healthy, avoid products from certain countries because they have historic high pesticide use or high heavy metal content in certain products.

While not all companies call out their ingredients’ origins, some brands do so precisely because some consumers rely on that information for health reasons. By removing transparency on food origin, the FDA is making it harder for those consumers to choose foods they feel will benefit their health more.

2. Bleached Flour (21 CFR 137) (no comment)

1. Vending Machine Labeling (no comment)