Market Overview

Impossible Foods Receives No-Questions Letter from US Food and Drug Administration

  • In stating it has "no questions," FDA accepts expert panel's unanimous
    conclusion that Impossible Foods key ingredient is safe to eat
  • Impossible Foods welcomes the FDA's publication of test data for
    public review
  • Now available in nearly 3,000 locations, the Impossible Burger will
    continue to be sold in restaurants, corporate canteens, universities
    and other foodservice locations in the United States and Hong Kong.

Impossible Foods has received a no-questions letter from the US Food and
Drug Administration, accepting the unanimous conclusion of a panel of
food-safety experts that its key ingredient is safe to eat.

Impossible Foods makes meat directly from plants -- with a much smaller
environmental footprint than meat from animals. The company uses modern
science and technology to create wholesome and nutritious food, restore
natural ecosystems and feed a growing population sustainably.

The company's flagship product, the Impossible Burger, is available in
nearly 3,000 locations in the United States and Hong Kong. It's the only
plant-based burger featured in America's most beloved "better burger"
concepts Fatburger, Umami Burger, Hopdoddy, The Counter, and B Spot (the
Midwest burger restaurant owned by Chef
Michael Symon
); earlier this year, America's original fast-food
restaurant, White Castle, added
the Impossible Slider
to menus in 140 restaurants nationwide.

Above and beyond strict compliance

The Impossible Burger is made through a combination of plant-based
ingredients. A key ingredient is "soy leghemoglobin." Soy leghemoglobin
is a protein that carries "heme,"
an iron-containing molecule that occurs naturally in every animal and
plant. Heme is the "magic ingredient" that enables the Impossible Burger
to satisfy meat lovers' cravings.

Before issuing its no-questions letter, the FDA reviewed comprehensive
test data about soy leghemoglobin to assess its status as "generally
recognized as safe," or GRAS. As standard process, the FDA posted the full,
1,066-page submission from Impossible Foods
on its website for
public review. FDA researchers also reviewed the comments of top food
safety experts, who unanimously concluded multiple times that soy
leghemoglobin is safe to eat and compliant with all federal food-safety

"We have no questions at this time regarding Impossible Foods'
conclusion that soy leghemoglobin preparation is GRAS under its intended
conditions of use to optimize flavor in ground beef analogue products
intended to be cooked," the FDA stated.

"Getting a no-questions letter goes above and beyond our strict
compliance to all federal food-safety regulations," explained Impossible
Foods CEO and Founder Dr. Patrick O. Brown, also Professor Emeritus of
Biochemistry at Stanford University. "We have prioritized safety and
transparency from day one, and they will always be core elements of our
company culture."

In issuing the no-questions letter, the FDA also noted that soy
leghemoglobin could be considered a "color additive" in some potential
future applications. The FDA has a separate regulatory process to
approve the use of food additives specifically for color, and Impossible
Foods is preparing to engage in that process to ensure it has maximum
flexibility as its products and business continue to evolve.

Heme: The awesome ingredient you eat every day

Heme is an essential molecular building block of life, one of nature's
most ubiquitous molecules. It is most familiar as the molecule that
carries oxygen in your blood.

Heme is in virtually all the food we eat, and it's particularly abundant
in animal muscle. It's the abundance of heme that makes meat (both meat
from animal carcasses and Impossible Foods' meat from plants) uniquely
delicious and craveable. Heme is not just safe
to eat
- it's required for life.

To satisfy the global demand for meat at a fraction of the environmental
impact, Impossible Foods developed a far more sustainable, scalable and
affordable way to make heme and therefore meat, without the catastrophic
environmental impact of livestock
. The company genetically
and ferments yeast to produce a heme protein naturally
found in plants, called soy leghemoglobin.

The heme in the Impossible Burger is identical
to the essential heme humans have been consuming for hundreds of
thousands of years in meat — and while the Impossible Burger delivers
all the craveable depth of beef, it uses far fewer resources.

Producing the Impossible Burger uses about 75% less water, generates
about 87% less greenhouse gases and requires around 95% less land than
conventional ground beef from cows.

Committed to safety and transparency

Impossible Foods has prioritized safety and transparency since the
company's founding, and the Impossible Burger has complied with all
food-safety regulations since before it was available to the public.

In 2014, years before the company began selling product to restaurants,
a panel of leading food safety experts gave the opinion that the
Impossible Burger's key ingredient, soy leghemoglobin, is "generally
recognized as safe." GRAS
means a food is safe to be consumed under US regulations.

Additional testing -- including a stringent
rat feeding study
-- provided even more objective, scientific data
that the product is safe. A 2016 study examined whether consumption of
soy leghemoglobin in amounts orders of magnitude above normal dietary
exposure would produce any adverse effects. There were none. And a
comprehensive search of allergen databases found that soy leghemoglobin
has a very low risk of allergenicity, and it's shown no adverse effects
in exhaustive testing.

In August 2017 the same panel of food safety experts reviewed the
additional data we provided and again unanimously concluded that soy
leghemoglobin was safe. In fact, the panel concluded that the new data
further strengthened the safety case. In October 2017, Impossible Foods
filed this additional new information with the FDA in a 1,066-page
submission. Having reviewed that new safety information, the FDA
declared today that it now has no questions regarding the safety of soy
leghemoglobin in the Impossible Burger.

About Impossible Foods:

Based in Redwood City, Calif., Impossible Foods makes delicious,
nutritious meat and dairy products directly from plants -- with a much
smaller environmental footprint than foods from animals. The privately
held company was founded in 2011 by Patrick O. Brown, M.D., Ph.D.,
Professor Emeritus of Biochemistry at Stanford University and a former
Howard Hughes Medical Institute investigator. Investors include Khosla
Ventures, Bill Gates, Google Ventures, Horizons Ventures, UBS, Viking
Global Investors, Temasek and Open Philanthropy Project.

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