FDA Citizen Petition 
by Tricia Spencer
Dockets Management 
Division of Dockets Management
Food and Drug Administration
5630 Fishers Lane
Room 1061, HFA-305
Rockville, MD 20852 






UNITED STATES DEPARTMENT OF HEALTH AND HUMAN SERVICES
FOOD AND DRUG ADMINISTRATION





CITIZEN PETITION





Petition to Require Food Manufacturers to List Nutritional Data 
for Every Edible Component, Including Liquid, in a Food Container





Submitted by

Tricia Spencer




June 12, 2015

Citizen Petition


    The undersigned citizen submits this petition under the Federal Food, Drug, and Cosmetic Act to request the Commissioner of Food and Drugs to take the actions described in Section A with respect to nutritional data represented on nutrition labels of packaged foods.



A. Actions Requested


    This petition requests that the Food and Drug Administration take two distinct actions.

    1) Abandon the "customarily consumed" and/or the "majority rules" benchmarks for determining nutritional data on food labels. 

    2) Require all food manufacturers to adhere to 100% truthful uniformity in providing nutritional data to consumers, with no undisclosed caveats, omissions, or misrepresentations.  



B. Statement of Grounds


    1) "Customarily Consumed" - "Food Consumption Data"

    The basis for determining whether or not to include packing liquid (or any other seemingly fringe ingredient) in the nutritional data of any food is flawed on its face. Nutrition and health should be held to a higher standard than "majority rules". If even one person consumes the liquid in packaged foods, that single person is entitled to the whole truth and nothing but the truth about what he or she is eating.  

    "Customarily consumed" surveys are not all-inclusive, can be skewed by targeting specific consumers, and, for the purpose of determining nutritional data, result in the dissemination of inadequate and misleading information to the public. "Food consumption data" surveys should be abolished as the benchmark for whether or not nutritional data is required for every edible ingredient. The Internet is teeming with recipes (even those created by food manufacturers themselves) that call for utilizing the liquid in canned fish, fruits, vegetables, etc., and it takes but a quick look to find consumers' first-person accounts of eating packing liquids in one form or another. The undersigned is included in that number, routinely consuming the olive oil in which sardines are packed and utilizing the brine from pickles and the juice from canned fruits in recipes.

    100% honest and complete disclosure should be the one and only benchmark for determining nutritional data. Anything less contributes to the obesity and ill-health crisis in this country. As the gate-keeper of our food supply, the Food and Drug Administration has an obligation to protect the consumer from misinformation and selective omissions on food packaging labels. The "customarily consumed" caveat benefits food manufacturers and harms consumers, but the harm can be reversed with the implementation of a simple "100%" rule. If it's in the package, and it's edible, it must be included in the nutritional data. No exceptions.




Examples of Consumption of Liquids in Packaged Foods


    It's easy to debunk the theory that Americans do not consume the packing liquids in packaged foods. Below are readily available examples of the truth.



Actual reviews left on AMAZON.COM for canned sardines 
(bold emphasis and enlarged font added by petitioner, but comments unedited)

Will be buying more
By Eric on July 8, 2014
Verified Purchase
I hope its ok to eat everything inside, cause I did, including the olive oil. Delicious!

Very good
By M. Shapiro on May 30, 2014
Verified Purchase
Boneless and skinless. Unfortunately the price as of 5/29/2014 has increased by 50% - this in just 2 months! The olive oil tasted good and seemed like the real thing.

yum!
By Lily on April 10, 2014
Verified Purchase
This is something I will order again. The sardines are tasty and not too salty. There is a lot more olive oil than I expected, however, which is great that I would eat it with some bagels and avocado.

Wonderful
By E. K. B. "eblunt777" on January 10, 2014
Verified Purchase
They are much different from the 'cheap' counterparts. If you are trying to eat for health reasons, and the idea of a canned fish scares you, try this. Look at local store before committing to a dozen. The combo of no bones and olive oil make it more antipasto than seaside carnage

I like then a lot, no bones
By mikescooling "book-worm"on October 16, 2012
Verified Purchase
I like it that these are bone less. They come in olive oil and that is good too. I was hunting with friends and we had crackers and these; I smashed them into the oil and made a past to serve on the crackers, uummm it was so good...



Following is a recipe incorporating the oil from canned sardines 
from Chef Alton Brown of the Food Network
(bold emphasis and enlarged font added by petitioner)



Sherried Sardine Toast 

Recipe courtesy of Alton Brown  

SHOW: 
Good Eats 
EPISODE: 
Live and Let Diet 

Total Time: 
20 min 
Prep: 
15 min 
Cook: 
5 min 

Yield: 
4 servings 

Level: 
Easy 

Next Recipe 
Sherried Sardine Toast 
(02:36) 

Sardines scare you? Alton's Sherried Sardine Toast will change all that. 
Ingredients 

2 (3.75-ounce 2-layer) tins brisling sardines in olive oil 
2 tablespoons finely chopped parsley leaves, divided 
1 tablespoon sherry vinegar 
1/4 teaspoon lemon zest, reserve the lemon and cut into 4 wedges 
Freshly ground black pepper 
4 (1/2-inch) thick slices crusty bread, such as sourdough, country loaf or rye 
1 ripe Hass avocado 
Coarse sea salt 

Directions 

Drain the oil from 1 tin of sardines into a small bowl and set aside. Drain the oil from the other tin into another small bowl and whisk in 1 tablespoon of parsley, vinegar, lemon zest, and black pepper, to taste. Add the sardines, stir to combine and set aside for up to 1 hour. 

After 45 minutes, put a rack 3-inches from the broiler and heat the oven to the broiler setting on high. Brush each slice of bread on 1 side with the reserved oil. Put the bread, oil side up, onto a cooling rack set inside a half sheet pan and broil 2 to 3 minutes or until golden brown and crisp. 

Halve the avocado and remove the pit. Smash the flesh in each half with a fork. 

Spread the avocado evenly onto the toasted bread. Top evenly with the sardines. Pour any remaining dressing on top and garnish with the remaining parsley. 

Season lightly with sea salt and serve with lemon wedges. 

Recipe courtesy Alton Brown, 2009




Below is a recipe incorporating the juice in canned fruits from country music star Trisha Yearwood, featured on the Food Network


Easy Peach Cobbler 

Recipe courtesy of Trisha Yearwood  

SHOW: 
Trisha's Southern Kitchen 
EPISODE: 
Family Fish Fry 

Total Time: 
1 hr 30 min 
Prep: 
10 min 
Inactive: 
20 min 
Cook: 
1 hr 

Yield: 
8 servings 

Level: 
Easy 

Next Recipe 
Easy Georgia Peach Cobbler 
(03:15) 

Trisha brings a touch of Georgia to Oklahoma with her Easy Peach Cobbler. 
Ingredients 

Two 15-ounce cans sliced peaches in syrup 
1/2 cup (1 stick) butter 
1 cup self-rising flour 
1 cup sugar 
1 cup milk 
Homemade Whipped Cream, recipe follows 
Cook's Note: If you don't have self-rising flour, substitute 1 cup all-purpose flour mixed with 1 1/2 teaspoons baking powder and 1/8 teaspoon salt 
Homemade Whipped Cream: 
2 cups whipping cream, chilled in the fridge 
4 tablespoons sugar 

Directions 

Preheat the oven to 350 degrees F. 

Drain 1 can of peaches; reserve the syrup from the other. Place the butter in a 9- by 12-inch ovenproof baking dish. Heat the butter on the stove or in the oven until it's melted. In a medium bowl, mix the flour and sugar. Stir in the milk and the reserved syrup. Pour the batter over the melted butter in the baking dish. Arrange the peaches over the batter. Bake for 1 hour. The cobbler is done when the batter rises around the peaches and the crust is thick and golden brown. Serve warm with fresh whipped cream 
Homemade Whipped Cream: 

Chill a large metal mixing bowl and the wire beater attachment in the freezer for about 20 minutes. Pour the chilled cream and sugar into the cold mixing bowl and beat until it forms soft peaks, about 5 minutes. The mixture should hold its shape when dropped from a spoon. Don't overbeat or you'll have sweetened butter! Yield: 4 cups. 

Recipe adapted from Georgia Cooking in an Oklahoma Kitchen by Trisha Yearwood (c) Clarkson Potter 2008 



The following recipe advocating the use of pickle juice, is from 
Ted Wietrzykowski, Polish Village Café, as seen on the Food Network

Dill Pickle Soup 


Recipe courtesy Ted Wietrzykowski, Polish Village Cafe 

SHOW: 
Diners, Drive-Ins and Dives 
EPISODE: 
Old to New 


Total Time: 
45 min 
Prep: 
15 min 
Cook: 
30 min 

Yield: 
8 servings 

Level: 
Easy 

Next Recipe 
Ingredients 

5 tablespoons butter or margarine 
5 medium carrots, shredded 
2 large potatoes, cubed (about 2 cups) 
3 large dill pickles, shredded 
1 cup flour 
1 cup sour cream 
Salt 
Pickle juice 

Directions 

Combine 5 cups water, the butter, the carrots and potatoes in a saucepan. Bring to a boil and cook until the potatoes are tender. Add the pickles and continue to boil. 

Meanwhile, whisk together the flour, sour cream and salt in a separate bowl. Add enough water to make a paste, then slowly, to avoid curdling, add the mixture to the soup to thicken. Bring to a boil, then remove from the heat. Add pickle juice, to taste. 

This recipe was provided by a chef, restaurant or culinary professional and may have been scaled down from a bulk recipe. The Food Network Kitchens chefs have not tested this recipe, in the proportions indicated, and therefore, we cannot make any representation as to the results. 

Recipe courtesy Ted Wietrzykowski, Polish Village Cafe 



Finally, below are two of many dessert, breads, and other recipes that come directly from DOLE®, a packaged food manufacturer, advocating the use of the liquid from their canned fruit in the recipe


Glazed Orange Rose Cake 






Prep Time 10 minutes 
Total Time 1 hours 
Difficulty 1.0 Easy 
Calories: Per Servings 320 Calories 
Servings 12 
Nutrition facts 

About 
This cake can be baked in this special rose cake pan for a fun presentation or in a regular bundt pan. Either way it is a great orange flavored cake that friends and family will enjoy! 
Ingredients 6 

Ingredients:
1 can (15 oz.) DOLE® Mandarin Oranges
1 box (2 layer) yellow cake mix
3 eggs
1/2 cup vegetable oil
1 orange, peel grated and juice reserved (optional)
1 cup powdered sugar

STEP 1
Direction 
Preheat oven to 350F. Spray rose shaped bundt pan with cooking spray for baking with flour, or flour and grease pan. Drain mandarin oranges; reserve juice

STEP 2 
Direction 

Combine cake mix, juice from can, eggs, oil, and orange peel in a large bowl; beat 2 minutes. Pour 1/3 batter in prepared pan; layer half of mandarin orange slices. Pour another 1/3 cake batter into pan; layer with remaining oranges. Pour remaining cake batter into pan. 

STEP 3 
Direction 

Bake 40 to 45 minutes or until toothpick inserted in center comes out clean. Cool in pan 20 minutes. Remove from pan onto wire rack; cool completely. 

STEP 4 

Ingredients: 
1 orange, peel grated and juice reserved, optional
1 cup powdered sugar
Direction 
Combine juice from orange and powdered sugar in a small bowl; whisk until well blended. Gently brush glaze all over cake with pastry brush.



Hawaiian Bread 






Prep Time 1 hours 
Total Time 1 hours 
Difficulty 2.0 Medium 
Calories Per Servings 280 Calories 
Servings 12 
Nutrition facts

About 
A great bread to serve at brunch. 

Ingredients 7 


STEP 1 
Direction 

Preheat oven to 350°F. 

STEP 2 

Ingredients: 
1/2 cup sugar
1/4 cup butter or margarine, softened
2 eggs
1 can (8 oz.) DOLE® Crushed Pineapple, undrained
1/3 cup chopped macadamia nuts or walnuts
1 cup flaked coconut, divided
2 cups prepared baking mix 

Direction 
Cream sugar and butter in large bowl. Add eggs one at a time; beat well. Add undrained pineapple, nuts and 1/2 cup coconut and mix well. Stir in baking mix until just blended. 

STEP3 
Ingredients 
Vegetable cooking spray 

Direction 
Pour batter into 9 x 5-inch loaf pan, sprayed with vegetable cooking spray. Sprinkle and lightly press remaining 1/2 cup coconut into top of cake. 

STEP4 

Direction 
Bake 50 minutes or until top is golden brown or wooden pick inserted in center comes out clean. 
STEP5 

Direction 
Cool in pan 10 minutes; remove from pan and cool slightly on wire rack. Serve warm. 





Discussion: "Customarily Consumed" - "Food Consumption Data"



    The above reviews and recipes are just a small sampling of easily discovered examples that call for utilizing the liquids from packaged products. If a recipe by a respected chef, or one obtained from a family member or friend, is followed, but the nutritional information on the can or jar does not reflect any data for the liquid in the container, determining the nutritional impact of the completed recipe is impossible. The outcome is harmful. Any excuse for omitting the information is unacceptable.


    Whether or not DOLE voluntarily chooses to provide nutritional information for the liquid in their packaged foods is irrelevant if their competitors make the opposite choice. Could the above DOLE recipes be made using fruit from other manufacturers? Of course. But if there is no uniformity in the nutritional labeling from manufacturer to manufacturer, the consumer is denied a true and complete nutritional disclosure, resulting in false calories and nutritional impact of a finished recipe. Is this beneficial to consumers? No. Does it contribute to obesity? Absolutely. Simply consuming the oil in a can of sardines 5 times a week, without the knowledge that the oil has not been included in the calorie count, can produce a weight gain of nearly 10 pounds in a single year. Multiply that by the consumption of several products with undisclosed nutritional data, and it's apparent just how harmful the FDA's current nutrition labeling caveats are to public health and well-being.



2) Uniformity in Nutritional Labeling


    With the FDA's express approval, the current nutritional labeling for food items packed in liquid is voluntary on the part of the manufacturers, resulting in unacceptable inequity for the consumer. For example, some SEASONS brand sardines lists the nutritional data for its single-can serving of sardines by including every item (including the liquid) in the can. CROWN PRINCE brand sardines does not.  

    As admitted to the undersigned, CROWN PRINCE drains its sardines of the olive oil (or mustard, or other liquid) before running the nutritional analysis. They are doing nothing wrong, because that behavior is sanctioned by the FDA. But the result is deception, whether or not intended. In spite of clearly listing its serving size as "1 can", the company justifies its decision to drain first by listing the serving size on the back of the packaging (80 g) to be different than the content listed on the front of the packaging (106 g). Noticing that difference, then somehow surmising that it is because the sardines have been drained, is an undue, unfair burden on the consumer, and it plain doesn't work. 

    The lack of uniformity in labeling by manufacturers is understandably harmful. As seen above, manufacturers of canned fruits frequently tout their own recipes for dishes that contain the liquid in the fruit can or jar. Yet whether or not that liquid is even included in the nutritional data contained on the packaging depends upon the manufacturers' will. Some may include it, while others do not. Such voluntary labeling is blatantly harmful to consumers. 



The Food and Drug Administration's permission to companies to conduct themselves in such manner is 
the root of the problem.


    Food manufacturers benefit from misleading nutritional data. By not including the liquid (or other seemingly fringe ingredient) in nutritional labeling, they are, by the lie of omission, purporting that their product is lower in calories (and fats, sugars, salts, etc.) than it actually is. Such inadequate and misleading labeling is devastating to those who care about nutrition.

    Consumers are routinely instructed to "read the labels" of foods eaten, but doing so is useless if the information on those labels is wrong from the start.  

    Voluntary nutritional data labeling does not work. Worse, it damages the health and well-being of the consumers who rely on the Food and Drug Administration for the truth about the food supply. 100% truthful inclusion is the solution and the standard by which all foods should be labeled. The current, miles-long, complicated hodgepodge of nutritional data requirements, with all of the caveats and exceptions, is unnecessary. It is not only ineffective in protecting the consumer, it is a sanctioned sabotage. Truth is simple, and it works.



Viable Labeling Solutions



    1) THE BEST SOLUTION: Absolute truthful requirement.  

    Require that each serving contained in a food package reflects the full and complete nutritional data for every edible component or ingredient in that package, without any "free" percentages, such as the very common .5% threshold for trans fats. Trans fats are cumulative in the body, and those .5 percents add up, yet food manufacturers are permitted to tout "0 Trans fats!" in their product labeling when the truth is that eating even a single serving results in the consumption of dangerous trans fats. Simply tell the truth on the label: "Trans fats = up to .5% per serving." There's no need, or excuse, for hiding small percentages. Consumers have the right to the whole truth.

    2) THE SECOND-BEST SOLUTION: Dual labeling.  

    Give consumers the full picture by utilizing a side-by-side 2-column nutrition label. The first column would be labeled "DRAINED CONTENTS" and the second column would be labeled "CONTENTS INCLUDING LIQUID". This labeling would provide consumers with a clear choice (with clear consequences) regarding the consumption of the liquid in the can or jar.

 3) THE LEAST-BEST SOLUTION: A highly visible disclaimer.  

    On any package that contains liquid, require the wording: "NUTRITIONAL DATA FOR DRAINED CONTENTS ONLY". This least desirable solution is better than no solution, but it is far from fair to consumers. Unless the consumer can trust the ingredients label to list every single component, this solution is doomed. For example, any consumer who wishes to consume the liquid from a product with this label would have to figure out the nutritional data of that liquid on his or her own, but unless every ingredient or additive in that liquid is clearly and thoroughly identified, determining the nutritional impact of the liquid would be challenging if not impossible.



No Financial Harm to Manufacturers in Testing


    Research and communications with food analysis labs confirm that there is no additional financial burden to the testing process to test for the liquids in the packaging. All ingredients are analyzed as provided by the manufacturer, no matter the number of ingredients. Hence, disregarding the liquids in packaging is unnecessary. The only "cost" burden for utilizing the truth on labeling relates to promotion. Manufacturers benefit from the illusion that the food in the container is lower in calories, fats, etc. It's a marketing tool. But that marketing tool drives up the cost of health care and lowers the quality of life. With existing nutrition label regulations, consumers remain in the dark about the reality of the nutrition in the food supply, and the result is a sabotage of any dedicated effort to "watch what you eat". 



Discussion: Uniformity in Nutritional Labeling


    While disclaimers, like "Drained Contents Only", are better than nothing, they are barely better than nothing. Truth in labeling is simple and easy and the only right mandate from the FDA. Complete honesty and uniformity in labeling, from manufacturer to manufacturer, is the only way to provide consumers with the honest truth about the nutritional impact a particular food will provide. Anything less is detrimental to personal health and to the burden on the American health care system.

    Nutrition labels should not contribute to ill health and obesity by their sheer lack of competent information. A mandated change that requires food suppliers to provide 100% honest and complete nutritional information for every edible component in their food packages solves the problem.



C. CONCLUSION


    For the foregoing reasons, the undersigned believes that the current nutrition labeling by the FDA is inadequate and harmful, and as such, respectfully requests that the FDA stop using "customarily consumed" or "majority rules" as benchmarks for nutrition labeling. This change would provide every American citizen, whether a part of the majority or not, absolute access to 100% truthful nutritional data with which to improve health.  

    Further, the undersigned requests that the FDA adopt uniformity in nutrition labeling, barring manufacturers from voluntarily withholding any nutritional information from any packaged food. The labels should be uniform, truthful and reliable, and represent every edible component in the package, whether that information is provided by manufacturer "X" or by manufacturer "Z".

    The obesity and ill-health epidemic in our country is real, as is the oppressive cost of health care. Blindsiding consumers with less than 100% truthful nutrition labeling unnecessarily and shamefully fuels the epidemic and contributes to rising health care costs.  

    The FDA mission statement confirms in part that: "FDA is also responsible for ... helping the public get the accurate, science-based information they need to use medicines and foods to maintain and improve their health." As the gatekeeper of that accurate food information, it is the FDA's responsibility to put the consumer's health first. The current nutritional labeling requirements put food manufacturers first. That's wrong.

    This petitioner, with regard to all Americans who study nutrition labels in an effort to improve their health and well-being, asks the FDA to adopt a uniform, "truth, and nothing but the truth" mandate for nutrition labeling, applied to all manufacturers equally.




E. Environmental Impact


    The actions requested are subject to categorical exclusion and do not require preparation of an environmental assessment.



F.  Economic Impact


    No statement of the economic impact of the request actions is presented because none has been requested by the Commissioner.



D. Certification


    The undersigned certifies that to her best knowledge and belief, this petition includes all information and views on which the petition relies, and it includes representative data and information known to the petitioner, which are unfavorable to the petition.


Respectfully submitted,


(s)

Tricia Spencer


Docket #  FDA-2015-P-2247
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Petition Confirmation Letter from FDA:
Note: Because they were added after submission, before filing, Sections E and F appear out of order in the petition