Search results for: orange juice

  • On June 25, 2026, the USDA Agricultural Marketing Service (AMS) posted a final notice on its rulemaking to revise orange juice grading standards. AMS addressed comments, but stated that it will publish the changes as provided in the interim final notice, released in November, 2025.
  • As we have previously blogged, FDA released a proposed rule to lower the required minimum Brix content in August, 2025. Then-FDA Commissioner Marty Makary spoke about the rule in a video with US Secretary of Agriculture, Brooke Rollins. Makary said that “for years, we’ve been wasting beautiful American oranges simply due to an outdated regulation.”
  • Later, on November 18, 2025, USDA issued an interim final rule revising its grading system and deferring to FDA’s standard of identity (SOI) for Grade B pasteurized orange juice. The revisions took effect immediately, but USDA opened a 60-day comment period.
  • In its final notice, USDA addressed each of the five comments it received. Three expressed support for revising the Grade B Brix allowances, and one “was not responsive to the action in the interim final notice.” The fifth comment expressed concern over how revising these standards would impact the taste or nutritional quality of orange juice products. USDA responded that, according to FDA, these changes would have minimal impacts on taste or nutritional value.
  • AMS plans to publish the changes at its grades and standards webpage. Instead of providing a Brix value of its own, AMS will now direct readers to FDA’s standards in 21 C.F.R. 146.140(a).
  • Keller and Heckman will continue to monitor USDA developments.

  • On November 18, 2025, The U.S. Department of Agriculture (USDA) issued an interim final rule (IFR) revising its grading standards for pasteurized orange juice to align with the Food and Drug Administration’s (FDA) proposed modernization of the standard of identity (SOI).
  • This action follows FDA’s August 2025 proposed rule to lower the minimum Brix requirement for pastuerized orange juice from 10.5 percent to 10 percent Brix, reflecting the naturally lower sugar content of Florida oranges due to citrus greening and severe weather conditions.  In a video created by FDA and USDA, FDA Commissioner Marty Makary, emphasized the broader policy goals behind this change: “For years, we’ve been wasting beautiful American oranges simply due to an outdated regulation, while relying on a high volume of imports.”
  • As we have previously blogged, FDA’s proposed rule (90 FR 37817) recognizes that Brix levels are “subject to the vagaries of nature” and outside manufacturers’ control.
  • Accordingly, USDA removed its own minimum Brix values for Grade B pasteurized orange juice and now defers to FDA’s standard of identity, which FDA has proposed to lower from 10.5 percent to 10 percent Brix. This means grading will follow FDA’s updated approach rather than USDA’s previous fixed values.
  • USDA concluded that the revisions are non-controversial, well-supported by industry, and unlikely to draw adverse comments. Therefore, the changes are effective immediately, and AMS will later issue a final notice to confirm the revisions.
  • Keller & Heckman will continue to monitor developments related to Brix requirements and other food standards modernization efforts.
  • Florida Natural Growers, Inc., was recently sued for allegedly falsely representing its Florida’s Natural orange juice products as being exclusively made from premium Florida orange juice despite being blended with juice from other countries. The plaintiff claims that Florida Natural knew that consumers would rely on Florida representations made on the label and be willing to pay more for Florida orange juice.
  • According to the complaint, labeling on the front of the package claiming “Owned by Florida Farmers” next to an American flag, as well as language on the side panel of the package about why the company is “different,” imply that the orange juice is made exclusively from Florida oranges. Further, the American flag is claimed to be an implied “Made in the USA” claim, which is regulated by the Federal Trade Commission and only permissible where “all or virtually all ingredients . . . are made and sourced in the United States.” 16 CFR 323.2.
  • The complaint also alleges that there is a strong connection between Florida and the citrus industry such that “consumers overwhelmingly preferred Florida orange juice” and are willing to pay a premium of approximately 50% for 100% Florida orange juice.
  • However, according to the plaintiff, because of a decline in citrus groves in Florida due to plant diseases, Florida Natural began including orange juice from Mexico and Brazil in its products beginning in 2022. Thus, the plaintiff claims, the claims on the orange juice label are misleading and deceptive.
  • Keller and Heckman will continue to monitor this case and other class action lawsuits related to food labeling.
  • In response to a citizen petition filed by the Florida Citrus Processors Association Inc. and Florida Citrus Mutual Inc., FDA has issued a proposed rule (90 FR 37817) which would change the standard of identity for pasteurized orange juice in 21 CFR 146.140 by lowering the required minimum Brix content from 10.5° to 10° Brix. Brix represents the percent of soluble solids by weight of an aqueous solution (calibrated to a sucrose solution). Most of the total soluble solids in Florida oranges are sugars, and the proposed reduction in Brix corresponds to a reduction of 1 g of sugar per 8 oz serving (from 18 g to 17 g/serving).
  • The pasteurized orange juice standard of identity (SOI) was issued in 1963 when the average brix of Florida oranges was 11.8° and the SOI was constructed to reflect the qualities of U.S. oranges at the time. However, since 2010-11 the average brix of Florida oranges has been decreasing due to a bacterial disease called “citrus greening disease” (also known as Huanglongbing) and severe weather. In 2022-2023, the average Brix level of Florida oranges was only 9.7°.
  • In the proposed rule, FDA recognizes that the Brix level in orange juice is “subject to the vagaries of nature,” is outside of the manufacturers control, and that the SOI should be updated to encompass the qualities of present-day Florida oranges. The change would expand the lower bound of acceptable Brix and would not prohibit manufacturers from producing orange juice with higher Brix.  FDA also states that the minor decrease in minimum Brix level is unlikely to affect the taste or flavor of the juice.
  • FDA invites comment on the proposed reduction in minimum Brix from 10.5° to 10°. It also requests comment on whether the minimum Brix level should be further lowered or whether the SOI for pasteurized orange juice should be dispensed of altogether to provide manufacturers with more flexibility. It notes that many juices, including apple juice are not standardized. Furthermore, it requests comment on whether the maximum percentage of citrus reticulata or citrus reticulata hybrids permitted in orange juice should be raised from its current 10% to 15%. Citrus reticulata has a higher sugar content, and therefore higher brix content, than citrus sinensis (scientific name for Florida oranges).
  • Any comments must be submitted by November 4, 2025, to Docket No. FDA-2022-P-1668 for “Food Standards of Identity Modernization; Pasteurized Orange Juice; Proposed Rule.”

  • Yesterday, FDA announced its issuance of a request for information on a citizen petition asking the Agency to amend the standard of identity (SOI) for pasteurized orange juice (POJ) by lowering the minimum soluble solids content, known as the Brix level. The current SOI for POJ requires that the product contains not less than 10.5 percent by weight of orange juice soluble solids (also expressed as degree Brix), exclusive of the solids of any added optional sweetening ingredients, and the ratio of the Brix hydrometer reading to the grams of anhydrous citric acid per 100 milliliters of juice is not less than 10 to 1 pursuant to 21 CFR 146.140(a).
  • The citizen petition, Docket No. FDA–2022–P–1668, filed by the Florida Citrus Processors Association and Florida Citrus Mutual on July 25, 2022, asks the FDA to reduce the Brix level, or minimum soluble solids requirement, from 10.5 to 10 percent, citing that the average Brix level of Florida’s orange crop has steadily dropped over the past couple of decades due to a bacterial disease called “citrus greening” and severe weather. Lowering the minimum level of soluble solids might reduce the sweetness of the juice and the levels of certain nutrients.
  • The request for information seeks comment on several areas, including consumer acceptance and nutritional value of pasteurized orange juice with a lower minimum soluble solids content. The FDA is requesting the information to determine whether the SOI for pasteurized orange juice should be amended.
  • Comments are due by October 16, 2023 and may be submitted electronically here. Specifically, FDA requests comments, data, and information about the issues presented in the petition.
  • Keller & Heckman will continue to monitor developments regarding the SOI for POJ.
  •  FDA recently posted a March 5, 2021 Warning Letter to Panther James LLC for the manufacture of untreated juices without a Hazard Analysis and Critical Control Point (HACCP) plan and the required 5-log reduction of the pertinent microorganism that are required under the Juice HACCP regulations at 21 CFR Part 120.  The same violations were the subject of a February 1, 2019 Warning Letter involving Apple Lemon Ginger, Beet #1, Beet #2, Beet #3, Green #1, Green #2, Green #3, Green #4, Carrot Orange Beet, Ginger Shot, Turmeric Shot, Immunity Potion and other juices manufactured at the company’s Berkley, MI facility and sold onsite and at its four retail establishments in the Detroit metro area, as well as distributed wholesale, under the “DROUGHT” brand name, to non-related business entities.
  • While noting that the exemption from Juice HACCP for a “retail establishment” does not apply here because juice from Panther James’ Berkley facility is sold to other business entities, FDA explains that if it was exempt from Part 120 and not also exempt from registering as a food facility, it would be subject to the preventive control requirements of 21 CFR Part 117, which would require essentially the same food safety plan and hazard control measures as Juice HACCP.  Additionally, FDA’s letter explains how the different definition of “retail food establishment” under Part 117, as compared to “retail establishment” under the Juice HACCP regulations, means that the Berkley facility would not fall within the retail food establishment exemption from the requirement to register, even if sales to outside businesses were eliminated.
  • FDA’s recent action highlights how the Agency’s regulations allow only very limited exemptions from the requirement for a 5-log reduction of the pertinent microorganism in juices.  Although it is difficult to gauge the likelihood of further FDA enforcement action against DROUGHT juices, where no illnesses have been reported and no pathogens have been detected, any products that FDA has determined are not prepared, packed, or held in compliance with Juice HACCP, are presumed by law to be unsafe (adulterated per se).
  • On July 3, 2026, the White House’s Office of Information and Regulatory Affairs (OIRA) released its 2026 Regulatory Agenda, listing agencies’ projected regulatory actions and the timelines for them (although the actions and timelines are subject to change).
  • A closely watched item on the Regulatory Agenda is a proposed rule (which we previously blogged about) that would amend FDA’s regulations at 21 CFR parts 170 and 570 to require the submission of a generally recognized as safe (GRAS) notice for the use of a human or animal food substance that is purported to be GRAS under the conditions of its intended use (0910-AJ02). Under the proposed rule, FDA would maintain and update a GRAS notice inventory for all substances subject to the mandatory notification requirement and would clarify the process by which the agency determines that a substance’s use is not GRAS. The proposed rule is tentatively scheduled to be published in December 2026.
  • Other proposed rules include: (1) updating nutrient content claims for added sugars (0910-AJ20); (2) revoking standards of identity for (a) certain canned fruits and vegetables for foods no longer sold in the United States (0910-AJ21); (b) certain bakery products and cereal flours (0910-AJ22); (c) frozen peas and definitions associated with them (0910-AJ23); and (3) establishing conditions under which a specific ingredient would not be excluded from the dietary supplement definition, allowing products containing the ingredient to be lawfully marketed as dietary supplements, assuming they otherwise meet the dietary supplement definition (0910-AI91).
  • The Regulatory Agenda also includes plans to finalize rules to: (1) permit the use of fluid ultrafiltered milk, fluid ultrafiltered nonfat milk, fluid microfiltered milk, and fluid microfiltered nonfat milk in the manufacture of standardized cheeses and related cheese products (0910-AI42); (2) require the display of front-of-package (FOP) nutrition labeling for food products (0910-AI80); (3) permit the use of salt substitutes in standardized foods in which salt is a required or optional ingredient (0910-AI72); and (4) reduce the minimum soluble solids requirement for pasteurized orange juice (exclusive of the solids from any added optional sweetening ingredients) (0910-AI98).
  • Keller and Heckman will continue to monitor food related regulations in the Federal Register.
  • In an April 29, 2022 order, the U.S. District Court for the Northern District of California rejected Defendant BA Sports Nutrition, LLC’s motion for summary judgment as to Plaintiffs’ claims that the labeling of BodyArmor (a sports drink sold by BA Sports Nutrition) deceptively enticed them to buy BodyArmor by suggesting that it contained real fruit and/or fruit juice, when in fact it only contained natural flavors. BodyArmor sports drinks were named with fruit names (e.g., BodyArmor Orange Mango) and were labeled with pictures of fruits.
  • In doing so, the Court rejected BA Sports Nutrition’s argument that the labeling claims were nutrient content claims that were preempted by FDA’s regulation at 21 CFR 101.13 because it found no evidence that the claims were express or implied claims regarding nutrient levels.
  • Interestingly, the Court found that the flavor labeling regulation (21 CFR 101.22) was not relevant to the proceedings because sports drinks are “not commonly expected to contain a characterizing food ingredient.” See 21 CFR 101.22(i)(1)(i).
  • However, the Court did grant summary judgment in favor of BA Sports Nutrition as to Plaintiffs’ claims that they were induced into purchasing BodyArmor based on labeling claims that falsely stated that BodyArmor offered superior hydration and health benefits. The Court found that Plaintiffs’ claims were belied by their own deposition testimony which indicated that they were aware that: (1) hydration was not an objective measurable attribute, (2) BodyArmor had a high sugar content, and (3) sugar can be unhealthy.
  • The case serves as a reminder that, in addition to challenging an action on the grounds that a “reasonable consumer” would not be misled by the labeling/advertising in question, Defendants can also challenge that the Plaintiffs in the particular action were misled.