Market Entry and GRAS Modernization

In the U.S., many novel ingredients enter the market via the “Generally Recognized as Safe” (GRAS) pathway. This decades-old system allows a company’s expert panel to deem an ingredient safe based on scientific consensus, thus exempting it from formal food additive approval. Historically, GRAS determinations could be made independently without FDA notification, which let companies introduce new plant extracts, fibers, or upcycled ingredients relatively quickly. However, amid growing scrutiny, the FDA is moving to strengthen this framework. Regulators have announced plans to require mandatory FDA submission and review of all new GRAS conclusions, replacing the current voluntary notification program. In practice, this would mean companies must formally notify the FDA and publicly disclose safety data for any novel ingredient they consider GRAS, closing the loophole of “secret” self-affirmed GRAS uses. Such a reform, expected to be proposed by 2026, marks the biggest update to U.S. food-additive oversight in decades. It reflects FDA’s aim to align GRAS with modern science – ensuring that new ingredients from technologies like fermentation, synthetic biology, or upcycled sources meet current safety benchmarks. For innovators, mandatory GRAS review could modestly extend time-to-market due to added regulatory steps, yet it promises greater transparency and consumer trust in novel foods. Companies may need to invest more in toxicology studies and documentation upfront, but in return they gain a clearer path to regulatory acceptance. For example, the almond industry has been preparing a GRAS notice for almond hull powder (an upcycled fiber ingredient), following FDA-reviewed toxicity studies showing the hull flour is safe at relevant doses. FDA officials expect to complete the necessary safety assessments and notifications for such upcycled ingredients, indicating that novel by-products can achieve GRAS status when backed by solid evidence.

Labelling Guidance for Plant-Based Alternatives: Alongside safety, U.S. regulators are updating labelling standards to keep pace with plant-based product innovation. The FDA has issued new guidance on the naming and labelling of plant-based alternatives to traditional animal-derived foods, aiming to prevent consumer confusion. In early 2023, FDA released a draft guidance specific to plant-based milk alternatives (such as almond, oat, or soy “milk”). This guidance affirms that these products may be labeled with terms like “milk” (reflecting common usage), but it recommends voluntary nutrient statements to clarify nutritional differences from cow’s milk. For instance, a carton of almond milk might state “Contains lower protein than dairy milk” on the label. The goal is to ensure labels are truthful and help consumers make informed choices about novel foods’ nutritional profiles. Building on that, in January 2025 the FDA proposed draft guidance for labelling a broader range of plant-based alternatives – including meat, egg, and seafood substitutes (excluding the already-addressed milks). This draft, once finalized, will recommend best practices in naming (so that a plant-based burger or cultured “seafood” is named in a way that conveys its true nature) and in emphasizing distinctions from the conventional foods they emulate. For companies, these evolving labelling rules mean product development must go hand-in-hand with clear marketing. A creative name alone is not enough – firms must be prepared to describe their novel ingredient (e.g. an almond-protein “flour” or mushroom-based meat analog) in terms that meet legal standards and educate consumers. In some cases, businesses might adjust formulations (for example, fortifying plant milks) to address nutritional gaps highlighted by required disclosure, thereby spurring improvements in the products themselves. We explore reformulations here.

FDA Oversight and Innovation Climate: The FDA has also taken steps to re-organize and sharpen its overall food oversight, which benefits regulation of novel ingredients. The agency’s foods program is being unified and elevated, with a new emphasis on food chemical safety and innovative ingredients. FDA leadership has outlined a vision of food serving as a vehicle for wellness, prompting initiatives to update decades-old regulations that may hinder innovation. One such initiative is a sweeping review of outdated Standards of Identity – the rules that rigidly define certain staple foods (from bread and jam to milk and peanut butter) by their ingredients and processing. In mid-2025, FDA announced plans to revoke or revise dozens of these standards that were deemed obsolete and unnecessarily restrictive. For example, certain definitions of milk, cheeses, breads, and canned foods are slated for removal to give manufacturers more flexibility in reformulating or using new ingredients. The agency’s intent is to eliminate rules “that no longer serve the interests of American families” and permit innovation in how traditional products can be made. More flexibility in standards could, for instance, allow a high-fiber upcycled flour to be used in standardized bakery products or enable plant-based components in foods that previously had fixed compositions. This deregulatory push, coupled with FDA’s increased focus on chemical risks and nutrition, creates a regulatory environment more welcoming to novel food technology provided that safety and honesty are assured. FDA’s Human Foods Program has signaled it will “ensure chemicals in food are safe… and effectively regulate food ingredient innovation”. That includes not only pre-market review (like the GRAS reforms) but also post-market vigilance: the FDA is initiating systematic re-assessments of certain additives that gained approval decades ago, and accelerating reviews of new, naturally derived ingredients (e.g. color additives from fruits and vegetables to replace synthetic dyes). For an innovator, this means the path to market may involve more interaction with regulators and a need for strong scientific substantiation, but ultimately those novel ingredients that clear the bar could face fewer legacy barriers (such as restrictive definitions or unlabelled safety concerns). In sum, U.S. regulatory changes are trending toward greater oversight in the front-end (safety and labelling) while loosening rigid rules in legacy standards – a combination that encourages creative food solutions but insists they be introduced responsibly.

At RE-NUT®, we’ve already paved the regulatory path for in-shell almond ingredients: our almond milk and almond flour have achieved Self-GRAS status and the “no questions” letter from the U.S. FDA is due next year, confirming their safety for commercial use. In the EU, we are now in the final stages of the novel food approval process. Our patented technology – which processes the whole nut, including the shell – is applicable beyond almonds to peanuts and all nut types, enabling high-fiber, clean-label innovation across nut butters, milks, and flours. This regulatory readiness empowers brands to formulate boldly, without delays.