Monday, April 15, 2024

Imported Honey Still a Concern for Economically Motivated Adulteration

US FDA released results of economic adulteration of imported honey.   Between April 2022 and July 2023, FDA collected 107 samples of imported honey and found 3 samples (3%) to be violative. In 2021-2022, the agency collected and tested 144 imported honey samples, and found 10% of those samples to be violative. The two assignments were not designed for statistical comparison of violation rates.  The countries with violative samples - Dominican Republic (1), Mexico (1), and Yemen (1).

"“Honey” commonly refers to the thick, sweet, syrupy substance that bees make from the nectar of plants or their secretions and store in honeycombs (see FDA’s Proper Labeling of Honey and Honey Products: Guidance for Industry). Economically motivated adulteration occurs when products labeled as “honey” contains undeclared sweeteners that are less expensive than honey, such as syrups derived from cane, corn, rice, or sugar beets."

"The FDA used Stable Carbon Isotope Ratio Analysis (SCIRA) to analyze the organic composition of each honey sample. When the agency found a subsample to have carbon isotope values atypical to those of authentic honey, the agency classified the associated sample as violative/noncompliant."

https://www.fda.gov/food/cfsan-constituent-updates/fda-releases-report-economically-motivated-adulteration-honey
FDA Releases Report on Economically Motivated Adulteration in Honey
Constituent Update
April 8, 2024
The U.S Food & Drug Administration (FDA) is releasing data from a sampling assignment carried out in 2022 and 2023 to test imported honey for economically motivated adulteration (EMA). EMA occurs, for example, when a valuable ingredient or part of a food is intentionally left out, taken out, or is substituted or when a substance is added to a food to make it appear better or of greater value. The sampling was designed to identify products that contained undeclared sweeteners that are less expensive than honey, such as syrups from cane and corn. This assignment follows a previous EMA in honey assignment in 2021-2022 and was intended to identify whether there continues to be issues with EMA for imported honey.

As part of the assignment, conducted between April 2022 and July 2023, the agency collected 107 samples of imported honey and found 3 samples (3%) to be violative. In 2021-2022, the agency collected and tested 144 imported honey samples, and found 10% of those samples to be violative. The two assignments were not designed for statistical comparison of violation rates. When a sample was found to be violative, the FDA took swift action, including refusing entry into the U.S. and placing the associated company and product on Import Alert (IA). The agency also continues to develop methods to further improve the detection of undeclared sweeteners in honey to protect consumers.

The results of this assignment underscore the susceptibility of honey to EMA, reaffirming the FDA's commitment to testing and ensuring consumers receive fair value for their purchases. The FDA will continue to test honey for EMA under the agency’s import sampling and risk-based import entry screening program. Violative samples are subject to compliance actions, and in certain cases, the FDA may consider criminal investigations.

Additionally, the FDA continues to collaborate with our domestic and international regulatory partners to combat economically motivated adulteration of food products, including honey.

https://www.fda.gov/food/economically-motivated-adulteration-food-fraud/fy2223-sample-collection-and-analysis-imported-honey-economically-motivated-adulteration
FY22/23 Sample Collection and Analysis of Imported Honey for Economically Motivated Adulteration

As part of FDA’s continued effort to combat economically motivated adulteration, the Food and Drug Administration (FDA) conducted an assignment in 2022-23 to collect and test imported honey. Economically motivated adulterations are the substitution or addition of a substance in a product for the purpose of increasing the apparent value of the product or reducing the cost of its production, i.e., for economic gain. This assignment was preceded by a similar effort in 2021-22 also focused on imported honey. Previously, of the 144 import samples collected and tested, 14 (10%) were found to be violative due to economically motivated adulteration, a term used by the FDA for food fraud.

The FDA recognizes that the term “honey” commonly refers to the thick, sweet, syrupy substance that bees make from the nectar of plants or their secretions and store in honeycombs (see FDA’s Proper Labeling of Honey and Honey Products: Guidance for Industry). Economically motivated adulteration occurs when products labeled as “honey” contains undeclared sweeteners that are less expensive than honey, such as syrups derived from cane, corn, rice, or sugar beets.

The purpose of the 2022-2023 assignment was to identify imported honey products that are violative in that they contain undeclared added sweeteners and prevent them from being distributed in the U.S. market.

Methodology

The agency collected and tested 107 samples of imported honey from April 2022 to July 2023 to determine whether they contained certain undeclared added sweeteners. Each sample was made up of three subsamples, with each subsample containing at least 240 milliliters or 8 oz of honey (about a cup). FDA field personnel collected either bulk or retail samples labeled as “honey.” Retail samples consisted of individual jars or other containers intended for retail sale. Bulk shipment samples were collected typically from barrels or drums, with the use of appropriate collection equipment and procedures.

The honey samples evaluated were imported from 25 foreign countries. The FDA collected all the imported samples in import status, which refers to products collected at ports of entry or other locations where they are held prior to being released into domestic commerce.

The FDA used Stable Carbon Isotope Ratio Analysis (SCIRA) to analyze the organic composition of each honey sample. When the agency found a subsample to have carbon isotope values atypical to those of authentic honey, the agency classified the associated sample as violative/noncompliant.

Findings

Of the 107 import samples collected and tested, the FDA found 3 import samples (3%) to be violative. While the number of violative samples represents a slight decrease from the 2021-2022 imported honey assignment, the two assignments were not designed for statistical comparison. View full, published dataset.

A breakdown of the findings by country of origin is provided in the Table below (Table 1). The agency cautions against making inferences or comparisons among countries based solely on the Table 1 data in view of the small sample sizes and the fact that the agency did not design the assignment for such purposes.

Table 1. Number of samples collected and found violative by country of origin.
Declared country of origin Collected samples Violative samples
Argentina 5
Australia 1
Brazil 7
Canada 4
Chile 1
China 1
Dominican Republic (the) 5      1 violative sample
France 1
Germany 1
India 16
Italy 3
Mexico 20                     1 violative sample
New Zealand 6
Pakistan 3
Poland 6
Portugal 1
Romania 1
Saudi Arabia 2
Spain 1
Taiwan 1
Turkey 9
Ukraine 2
Uruguay 1
Vietnam 7
Yemen 2                         1 violative sample

TOTAL 107 3

Follow-Up Actions

When the FDA found a sample to be violative, the agency took follow-up action to prevent further distribution of that violative honey shipment into the US market. All violative samples resulted in refusal of entry for that shipment into the U.S. In addition, the FDA increased screening and surveillance sampling or placed the associated company and product on Import Alert (IA) 99-47. Products listed on the Import Alert are subject to Detention without Physical Examination. For those products to be admitted into the U.S., the company is required to provide evidence to the FDA to overcome the appearance of a violation, such as the test results of a third-party laboratory, verifying that the product does not contain added sweeteners.

Discussion

The results of this assignment show honey continues to be a commodity susceptible to economically motivated adulteration. The results reaffirm the need for the agency to continue to test honey for economically motivated adulteration to ensure consumers are not deceived and they get fair value for their purchase. Violative samples are subject to compliance actions, consistent with the FDA’s mission to ensure that food is safe, wholesome, and properly labeled. When appropriate, the agency may consider pursuing criminal investigations. The FDA also collaborates with international counterparts to detect and combat economically motivated adulteration related to imported products, including imported honey.

Honey can be adulterated with less expensive sweeteners derived from various plant sources including cane, corn, rice, and sugar beets. Different methods are needed to detect undeclared sweeteners from these various sources. The current method used by the FDA detects a subset of undeclared sweeteners. FDA continues to develop additional methods for the detection of undeclared sweeteners to protect consumers.

Companies that import honey, or that use honey as an ingredient in their food manufacturing, can help protect consumers by ensuring the authenticity of the honey. When other sweeteners are added to honey, the Federal Food, Drug & Cosmetic (FD&C) Act requires that the resulting product be labeled as a “blend,” and not as “honey,” and have an ingredient statement. Labeling on packaged food in interstate commerce is required to be truthful and not misleading, according to the FD&C Act.

For additional information on the FDA’s work to combat food fraud, please visit the agency’s Economically Motivated Adulteration (Food Fraud) page.

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