The famous "bloody", based on the Impossible Burger Plant, is now available in almost 5,000 restaurants in all 50 US states.
But it is precisely this appearance of bloodshed that can represent another regulatory impediment to the company and its efforts to get the product in supermarkets.
Impossible food, the producer of the eponymous burger from the Silicon Valley, uses genetically modified yeast in mass production of its central ingredient, soyme hemoglobin, or "haem".
It's heme, they say from the company, which gives the Impossible Burger its basic taste of meat.
The substance was ready to break through this summer after the US Food and Drug Administration, for several years now, refused to challenge the findings voluntarily presented by the company that the cooked product was "Generally Recognized as Safe" or GRAS. Such a "no questions" letter means that the FDA has determined that the information provided is sufficient.
Ham is "responsible for the taste of the blood," said the executive of the Impossible Food, Patrick Brown, in an interview earlier this year. "He catalyzes the reactions in your mouth that generate these very smelly molecules that smell bloody and metallic."
But, what seems to be at stake. A FDA spokesman said that red-haired chemists should be formally approved in addition to color before individual consumers can buy the unwanted product.
"If the firm wants to sell unrefined red strawberries of fennel to consumers, a prior permission for soy lechoglobin is needed as a color supplement," FDA spokeswoman Petar Kassel told Bloomberg in an e-mail dated 17 December. Impossible food filed a petition on November 5, demanding the official approval of Heme as a color supplement, the FDA announced. The agency has 90 days to respond, and the timeframe can be extended.
Impossible food says that cheme is not a color supplement, as used in cooked Impossible burgers sold in restaurants.
However, other future uses could qualify as a color supplement, said company spokeswoman Rachel Conrad in an e-mail. The company filed a request to the FDA to maintain "maximum flexibility, as our products and business continue to develop".
Conrad declined to say whether non-persistent products containing chemics for sale in supermarkets were one of those imagined future needs.
"Impossessed food is in full compliance with all federal food safety regulations and is from 2014, much before we start a product in restaurants in 2016," she said.
The FDA add-on to add color will not affect the continued sale of boiled Powerful Burgers to restaurants, and approval by the regulator of a petition for a color additive may come in time for the company to present the raw product next year as planned.
The request for this is definitely there. Once the province of animal welfare advocates and is aware of health, the alternative meat market has turned into white heat, given the great role that industrial meat production plays in global warming.
The largest competitor of Impossible, Beyond Meat, is supported by food giant Tyson Foods Inc. His bean beet bean bean, Beyond Burger is already sold at supermarkets and recorded 70 percent annual growth. The company even submitted an initial public offer.
The two impossible and wider are Microsoft's founder Bill Gates as a supporter (he helped raise $ 450m for Impossible.) Other meat giants, such as Cargill Inc., are also investing in the fast growing sector.
According to Neil Fortin, director of the Food and Drug Administration Institute at Michigan State University, a pet food additive petition for incredible foods probably involves evidence of Cheme's safety.
He said the regulator will assess the submission, will take a public comment and make a final decision.
While the safety standard for food additives and substances GRAS is the same, there is probably more to follow this evaluation: the FDA will make a more substantial security commitment than within the GRAS process, and the comment period opens the door to critics. The agency may also request more safety tests. (Impossible food and the FDA refused to share the petition with Bloomberg.)
"If you slow down the process and there is public comment and groups are reporting and scientists must confirm that it is safe, it creates a huge difference," Fortin said.
Heme is a natural molecule that contains iron-containing molecules and is abundant in the blood and muscles of the animals. It also exists in smaller quantities in plants such as soybeans, especially nodules on their roots, which Unfit Food collects for use in their hamburgers. The company pointed to the natural occurrence of Hemi in meat of animal origin, as a cause of taste as much as meat.
But the company also promoted its Impossible Burger, saying it looks like meat.
Except in certain categories, the company can start selling new ingredients in the US as food whenever and wherever it wishes, as long as the panel of experts from third parties has reviewed it and considers it safe.
If the government's blessing – a way to get consumer confidence – the company can present its results to the FDA. The regulator may either raise questions or accept the conclusions and issue a "no questions" letter.
The security standard applied by the FDA is, as Kassel said in his email, "reasonable security without any damage under the terms of intended use".
Impossible food summoned such an expert panel to assess the security of Cheme in 2014. When the FDA showed its evidence for the first time, the regulator said the company has yet to prove that Hem is safe.
The company followed with the submission of 1000 pages. It included studies of everything from allergens to identifying proteins to rats that were eaten by Ham for 28 days to show that it should be "generally accepted as safe". In July 2018, the FDA issued a "no questions" letter in response to the GRAS application for Impossible Foodstuffs.
The agency, however, offered a protest. "There is no GRAS provision for color accessories," the FDA wrote. Note: "Impossible Food", the preparation of soybean leechemoglobin is described as red / brown. As such, the use of the preparation of soybean leghemoglobin in food products (other than analogue products of beef meat intended to be cooked) may be the use of colors. "
Part of the potential consumer appeal of the unhealthy product is that it also looks like minced meat, "wrote Bloomberg, a spokeswoman for the FDA.
"Soy's leemoglobin gives a red color that is important for the appearance of food (ie makes it look like unwashed beef meat). Therefore, if the firm wants to sell unrefined, red-colored ground beef analogous to consumers, before -Simulation of soybean leechemoglobin as a color supplement is necessary. "
Conrad, a spokeswoman for the company, said the FDA had already fully appreciated and accepted Ham's security. She declined to say whether the company would postpone the implementation of the Impossible Burgers' raw materials to consumers until the FDA decided on its petition. "It is absurd to suggest that the very fact that leghemoglobin, an essentially safe ingredient, has a visible color should cause new security concerns," she said.
Foodstuffs used for food styles have long been facing tighter safety requirements of the federation. A higher level of control stems from a long history of American food and cosmetic companies that use dangerous chemicals for dyeing products. The Federal Law on Food, Medicines and Cosmetics since 1938 included new regulations on color, especially those derived from coal.
In the autumn of 1950, many American children were crushed by Halloween candy, which were found to have been made with a toxic orange-colored benzene. The next FDA investigation has shown that it is a widely used substance. In 1960, the law was amended to seek more federal oversight and approval before the market.
"According to the Food, Drug and Cosmetics Act, food is prescribed if there are colors that are not approved," said William Star, a lawyer for Benjamin L. England and Associates at Long Beach, California, and a consultant with FDAImports.com LLC. However, the critical difference is when the ingredient gives a random color, he said. To activate the FDA revision, the inclusion of the ingredient must be designed at least partially to add color.
"Advertising," said Tom Neltner, director of chemical policy at the Environmental Protection Fund, "is the best way to determine the intention."
In the past, Impossible Food outlined the appearance of the current product in marketing and other materials. Initially, the company called heme "Rubia", according to documents provided by the FDA in 2015.
The name was used at that time, said Conrad, "because FDA requires food producers to have a" common or common name "for the ingredients in GRAS notifications." In a July 2016 announcement, Impossible Food says its burgers will be available at Restaurant in New York's Momofuku Nishi.
In a statement, the company said the burger "looks, cooks, smells, sizzles and taste like conventional minced meat".
According to the version of the Frequently Asked Questions section on the "Impossible Food" website on August 24, 2017, available through the non-profit internet archive "Wayback Machine", "Hemi contributes to the characteristic color and taste of the meat."
Photographs of the hamburger, the media and the company's website at that time also show a red, bloody look of an intermediate rare burger.
In a letter dated 5 September 2017 to an advocate of Impossible Foods received from Bloomberg News, the FDA noted that the draft GRAS award in the company did not include a reference to "the color of the protein product or the effect that its color may have on the appearance of the intended food products ".
The regulator wrote that the website "Impossible Food" explains that "haem" also contributes to the characteristic color of the flesh and shows images of red and brown beef analog products.
"Although FDU spokesman Kassel declined to comment on the letter, he said in a telephone interview on Bloomberg on December 18 that" when we reviewed the GRAS notice, we came to the conclusion that it is not a color supplement under the intended purpose, which means in restaurants, and the company came to us to use it as a color additive for the new use, selling it to supermarkets. "
Conrad said heme was not added to his appearance. "It would be ridiculous to use a hue for color," she said, adding she has cheaper and lighter options, such as rapeseed juice. "Because the importance of heme stems from its impact on taste and smell, we do not emphasize its color in our marketing materials."
The senior said that, regardless of questions of intent, the new FDA auditor is unlikely to prevent Crucial Impossible Burgers from the supermarket. While the process of checking the additive colors is tougher than GRAS, he said that rejection of the haem as a color additive after having passed through GRAS is "very unlikely".
Food safety advocates say the whole episode is symbolic of major issues regarding the growing segment of meat alternatives, and beyond, the FDA's approval process itself.
Michael Hansen, a Consumers Union research scientist from the Consumer Reports Research Group, said that the ham used in the Impossible burgers should be considered a color supplement even in its cooked form and should not be marketed until it has received approval as such . Some additional, long-term tests have given consumers a better picture of product safety, says Lisa Lefferts, a senior scientist at the Center for Science in Public Interest.
"If people are going to eat this, they should be tested for its long-term effects," she said. (Hansen is critical of other food technologies, especially those involving genetic engineering. Leferts disagrees with previous FDA approval of sugar substitutes.)
Laura McCleary, CSPI policy director, said – without mentioning the Impossibly Food – that innovative companies do not need to look for shortcuts with certainty if they want to build trust with consumers. "It's incredibly counterproductive and short-sighted to think it's not a good investment in consumer confidence to seriously take all the security steps," she said.
Conrad dismissed any idea that Impossible Food Cuts Corners, saying the company "will never try to avoid any food safety or demand tests".
As for the FDA's process itself, advocates have long been upsetting the rules that allow products to be sold without being approved by the government. A group of consumers, health groups and food safety groups sued the FDA at the Manhattan federal court last year, calling the GRAS system "hole" for companies to break pre-market security checks of the government and to secretly add chemicals to food.
While GRAS laws are initially applied to well-known ingredients that are known to be safe, the groups argue that the FDA applies it to innovative ingredients that are new to human nutrition.
Although the regulator rejected the allegations of the lawsuit and contested the plaintiffs' existence of a lawsuit, the federal judge in September ruled that the plaintiffs could contest the GRAS rule, allowing the case to move forward.