Is Impossible Meat FDA Approved? What to Know About Its Safety

The Food and Drug Administration (FDA) has given Impossible Foods a "no questions" letter for its key ingredient, soy leghemoglobin, an essential step in confirming its safety. This provides assurance that Impossible meat is not only safe but also meets stringent federal requirements.

Quick Summary

Impossible Foods' main ingredient, soy leghemoglobin, has undergone multiple FDA safety reviews via the GRAS process and received a "no questions" letter, indicating the FDA's acceptance of the company's safety conclusion. The ingredient was also approved as a color additive, clearing the way for retail sales of the uncooked product.

Key Points

• GRAS Notification: Impossible Foods' key ingredient, soy leghemoglobin, was deemed Generally Recognized as Safe (GRAS) by the FDA via a "no questions" letter in 2018 after submitting extensive safety data.

• Color Additive Approval: In 2019, the FDA approved soy leghemoglobin as a color additive, which was necessary to allow for the sale of uncooked Impossible products in grocery stores.

• Comprehensive Safety Testing: The safety conclusion was based on extensive testing, including animal studies and allergen screening, addressing previous FDA inquiries.

• Legal Challenges Overcome: A federal appeals court upheld the FDA's safety determination in 2021 against legal challenges, affirming the substantial evidence for heme's safety.

• International Confirmation: Regulatory agencies in other countries, including Singapore, Canada, Australia, and New Zealand, have also independently confirmed the safety of soy leghemoglobin.

• Regulatory vs. Approval: It's important to differentiate between the GRAS notification process, which involves a safety conclusion, and a formal FDA pre-market approval, which is required for non-GRAS substances.

• No Formal Approval for Heme: While the FDA has reviewed and has no questions regarding the GRAS status of heme, it is not a formal 'approved' food additive in the same way as some other substances.

The question, "Is Impossible meat FDA approved?" is a common one among consumers concerned about novel food ingredients. The regulatory process for ingredients like Impossible's soy leghemoglobin does not follow a standard pre-market 'approval' model like pharmaceuticals. Instead, it operates under the 'Generally Recognized as Safe' (GRAS) pathway. Through this process, Impossible Foods has successfully demonstrated the safety of its key ingredient to the FDA.

The GRAS Pathway for Soy Leghemoglobin

Impossible Foods first pursued the GRAS determination for soy leghemoglobin in 2014, with a panel of experts affirming its safety. However, the initial notification was withdrawn after the FDA requested more data. Impossible Foods responded by submitting a new notification in 2017 with additional testing results, including animal studies.

The 'No Questions' Letter

In July 2018, the FDA issued a "no questions" letter for the GRAS notification, indicating that based on the provided information, the agency did not question the company's conclusion that soy leghemoglobin is safe for its intended use. This letter acknowledges the company's safety assessment but is not a formal FDA approval.

Color Additive Approval for Raw Product

Selling the raw Impossible patty required an additional step due to federal regulations concerning ingredients that impart color to food. Since soy leghemoglobin provides the product's red color, it needed to be approved as a color additive.

In July 2019, the FDA approved soy leghemoglobin as a color additive, enabling the retail sale of uncooked Impossible products. This separate approval further confirmed the ingredient's safety.

The FDA and Legal Challenges

Legal challenges have been brought against the FDA regarding its review of heme. However, in May 2021, a federal appeals court upheld the FDA's decision, stating that the agency had substantial evidence to support its safety finding. This legal outcome reinforces the FDA's rigorous process.

Comparison: FDA vs. Other Regulatory Bodies

Various international regulatory bodies have also reviewed the safety of Impossible Foods' ingredients. The European Union's review process differs from the FDA's GRAS pathway and color additive approval, and as of late 2023, it had not yet granted authorization for soy leghemoglobin. For a detailed comparison of regulatory bodies, {Link: see the Impossible Foods blog https://impossiblefoods.com/blog/setting-the-record-straight-regarding-the-center-for-food-safety-impossible-foods-long-standing-track-record-of-safety-and-transparency}.

Conclusion

While there isn't a single "FDA approval" document in the traditional sense, Impossible Foods has successfully navigated the US regulatory process through the GRAS notification for soy leghemoglobin. The FDA issued a "no questions" letter for GRAS and approved it as a color additive, allowing retail sales. Safety testing, favorable legal outcomes, and international regulatory confirmations support the safety of Impossible meat. For further details on the FDA's regulatory framework for food ingredients, you can visit the official FDA website.

Frequently Asked Questions

Did Impossible Foods get a formal FDA approval for its meat?

No, Impossible Foods did not seek a traditional pre-market FDA 'approval' for its main ingredient, soy leghemoglobin. Instead, it went through the Generally Recognized as Safe (GRAS) process, which resulted in a "no questions" letter from the FDA, signifying the agency's acceptance of the company's safety conclusion.

What is the key ingredient in Impossible meat that was reviewed by the FDA?

The key ingredient is soy leghemoglobin, a protein responsible for the product's meaty flavor and appearance, often referred to as 'heme' by Impossible Foods.

Why did the FDA need to approve Impossible Foods as a color additive?

The FDA required a separate color additive approval because soy leghemoglobin gives the uncooked Impossible patty its red, meat-like color. This approval was necessary to sell the product raw in grocery stores.

What does the FDA's 'no questions' letter mean for Impossible meat?

A "no questions" letter from the FDA indicates that the agency has no further questions challenging the company's own conclusion that its ingredient, soy leghemoglobin, is safe for consumption under its intended use.

Were there any safety concerns raised about Impossible meat?

Yes, some groups raised safety concerns regarding the novelty of soy leghemoglobin and challenged the FDA's review. However, the FDA's position was upheld in a federal appeals court, which found substantial evidence for the ingredient's safety.

Is Impossible meat approved for sale in other countries?

Yes, regulatory agencies in several other countries, including Singapore, Canada, Australia, and New Zealand, have also confirmed the safety of soy leghemoglobin, allowing for the sale of Impossible products.

How did Impossible Foods prove the safety of soy leghemoglobin?

Impossible Foods conducted and submitted extensive safety tests, including rat feeding studies and allergen analysis. This data formed the basis for their GRAS conclusion, which the FDA accepted.