Although typically less than 3% of a finished product’s volume, flavors play a significant role in delivering complete and accurate on-package communication. Getting flavor labeling right is essential for food and beverage manufacturers to meet FDA guidelines for safety and fulfill consumer needs for transparency. Regulatory teams know they must address flavor labeling complexities to reduce the risk of FDA enforcement or consumer litigation if labeling is incorrect.
Some of the flavor labeling challenges that food and beverage manufacturers and foodservice providers faced in 2020 have extended into 2021. And, as consumer demand for safe food expands, new food and flavor labeling regulations are on the horizon. Fortunately, insights about upcoming changes can make it easier to navigate the labeling landscape.
Temporary Labeling Changes Due to COVID-19
Pandemic-driven supply chain disruptions led FDA to provide interim guidance for relief to manufacturers at the end of May 2020. This allowance of temporary flexibility will cease with the discontinuation of COVID-19’s status as a national emergency. While the vaccine for COVID-19 has already started to roll out, supply chain obstacles may affect the immunization timetable needed for manufacturers to return to pre-pandemic operations.
Under the interim guidance, food manufacturers can use their existing labels when applying minor changes to their formulas, which would otherwise cause mandatory label changes. FDA provided the following details about appropriate changes to formulas that fall under the guidance scope. Use of existing labels is possible when the ingredient is minor and is present at less than 2% of the formula, the ingredient is not a significant ingredient (characterizing) or a source for a label claim, or the ingredient does not affect the finished product in function or nutrition.
The temporary changes apply to flavors if manufacturers want to replace them with appropriate substitutes meeting the same common name. For example, manufacturers must replace a natural flavor with a natural substitute and must replace an artificial flavor with an artificial alternative.
FDA gave additional clarification about flavor changes that fall outside the guidance and would require applicable label changes, including situations when the change affects a characterizing flavor, such as chocolate, and when it’s a primary, recognizable flavor in the food or beverage, such as chocolate milk; the source of an identity claim for a finished product for flavors with widely known taste profiles such as strawberry, banana, or watermelon; and when it is associated with a standard of identity which, in the world of flavors, only includes vanilla flavorings.
FDA also reminded manufacturers about the Food Allergen Labeling and Consumer Protection Act (FALCPA), which states that any ingredient change affecting allergen or sensitive ingredient presence in a product requires a modification to a manufacturer’s label.
Organic Certified Flavors
A 2018 ruling from the National Organic Program (NOP) went into effect at the end of 2019, requiring manufacturers to use certified organic flavors whenever commercially available. The ruling is a response to a 2014 petition from the Organic Trade Association (OTA) that pointed to the growing availability of certified organic flavors due to use of technologies by flavor providers that increase production efficiency of organic options, more monitoring by USDA that helps flavor manufacturers find and source ingredients from certified organic producers, and detailed guidance about the documentation flavor houses must obtain to verify flavor ingredient authenticity.
Flavors that make organic claims must meet the same standard as the end-product. The flavor must contain 95% or more organic ingredients and 5% or less non-organic ingredients.
The material list in the organic standard provides manufacturers with guidelines for flavor ingredients and identifies substances that don’t comply. An ingredient such as an amino acid, for example, would meet requirements for a natural flavor, but it doesn’t fit within the rules for certified organic flavors.
Labeling for organic flavors is more rigorous than for natural flavors. An organic flavor manufacturer must create and affix a lot number to bulk or non-retail packaging, just as with any other flavor. It must also share any non-organic natural flavors that are part of the formula with the certifier and use the word “organic” properly as a modifier. For example, a CPG manufacturer using a blueberry-type flavor with no organic blueberry derivatives in the formula could label it “organic flavor,” but not “organic blueberry flavor.”
When searching for certified organic flavor manufacturers, USDA’s NOP Organic Integrity Database, which lists certified organic operators, is a useful resource. A robust vetting process for flavor manufactures includes asking whether an operator has accurate and accessible documentation with evidence about the identity, purity, strength, and composition of flavor ingredients. Certificates of analysis, environmental certificates, and any import documents are also essential. Gathering insights into the supply chain used for organic flavor ingredients is also important. Supply-chain stability and expertise with logistics will help manufacturers manage any substitutions needed to meet launch schedules. It’s also important to conduct or review onsite inspection results. Whether CPG manufacturers rely on a third party or use their own experienced inspector, verification of compliance with certified organic requirements adds assurance to the flavor company’s NOP listing or website. Finally, you’ll want to assess the availability of R&D teams and organic suppliers for custom flavors and ingredients that meet regulatory requirements.
Certified organic flavor suppliers must meet the same requirements as other organic products. The NOP understands the transition from natural flavors to certified organic flavors is continuous but expects flavor manufacturers to demonstrate their process for finding organic replacements for non-organic natural flavors used in organic products and to show that they’re actively looking for organic alternatives to natural flavor ingredients.
National Bioengineered Food Disclosure Standard
In early July 2020, USDA’s Agricultural Marketing Service (AMS) issued four documents informing manufacturers about the National Bioengineered Food Disclosure Standard (NBFDS). The guidance offers manufacturers insights about the validation and test methods related to refinement procedures and detection of modified genetic materials in foods and beverages. Food and beverage manufacturers have until the end of 2021 to align labeling with the new ruling.
The documentation includes information about the proper determination of test methods, clarifications for limits of detection, terms definitions, and general steps to validate if a genetic modification is undetectable in an ingredient or finished product.
In addition to offering validation guidance, the AMS clarified that the NBFDS is solely for educational purposes and removed sections of the standard that explicitly referenced food safety. Importantly, “regulatory oversight by USDA and other federal government agencies ensures that food produced through bioengineering meets all relevant federal health, safety, and environmental standards.”
USDA defines a bioengineered (BE) food as one that “contains genetic material that has been modified through in vitro rDNA techniques and for which the modification could not otherwise be obtained through conventional breeding or found in nature.”
Notable points of the NBFDS include:
- Disclosure of highly refined foods and ingredients derived from BE crops, such as soy sauce or corn syrup, isn’t required;
- Incidental additives such as enzymes or yeast are exempt from BE disclosure and align with the ingredient declaration requirements under applicable FDA regulations;
- Manufacturers with sales lower than $2.5 million annually and food service providers are exempt;
- Foods certified under the NOP are exempt because the organic certification process already requires manufacturers to prove they aren’t using BE ingredients;
- Foods from animals that consumed bioengineered feed are not considered bioengineered food products;
- Food companies may use one of four options for disclosure on food labels: Text using the words “bioengineered food” or “bioengineered food ingredients”; a symbol with accompanying words; the use of electronic disclosures, such as a hyperlink or QR code, along with a telephone number to call for more food information; or a statement offering a phone number where consumers can send a text message to get the disclosure. Small packages and food sold in bulk receive special exemptions;
- The final BE rule establishes a threshold for the inadvertent or technically unavoidable presence of BE substances of up to 5% for each ingredient; there’s no threshold allowance for any BE presence that is intentional; and
- The compliance date set by USDA for BE disclosure is January 1, 2022.
Consumers use on-package information to understand the health implications of the food and beverages they purchase and eat. Federal law requires the ingredient statement and nutrition facts panel to include essential details about nutritional content, ingredients, and known allergens. Continuing to monitor the regulatory landscape and adhere to flavor and food labeling guidelines will help manufactures maintain consumer trust and build brand loyalty in 2021.
Buffinga is a regulatory manager at FlavorSum. Reach her at firstname.lastname@example.org.