USDA Solicits Public Comment on Labeling Meat and Poultry Products Derived from Animal Cells

 

On September 2, 2021, the U.S. Department of Agriculture’s Food Safety and Inspection Service (“FSIS”) published an advanced notice of proposed rulemaking to solicit comments from the public regarding the labeling of meat and poultry products made using cultured cells derived from animals. FSIS stated that it would use those comments to make further regulatory requirements.

FSIS also asked for economic data and consumer research to help increase its understanding of the animal cell culture technology industry and related issues regarding labeling and consumer perceptions of food made using this technology.

FSIS asked for public comment on the following fourteen questions:

1. Should the product name of a meat or poultry product comprised of or containing cultured animal cells differentiate the product from slaughtered meat or poultry by informing consumers the product was made using animal cell culture technology? If yes, what criteria should the agency consider or use to differentiate the products? If no, why not?
2. What term(s), if any, should be in the product name of a food comprised of or containing cultured animal cells to convey the nature or source of the food to consumers? (e.g., "cell-cultured" or "cell cultivated.")
   1. How do these terms inform consumers of the nature or source of the product?
   2. What are the benefits or costs to industry and consumers associated with these terms?
   3. If meat or poultry products comprised of or containing cultured animal cells were to be labeled with the term "culture" or "cultured" in their product names or standards of identity (e.g., "cell culture[d]"), would labeling differentiation be necessary to distinguish these products from other types of foods where the term "culture" or "cultured" is used (such as "cultured celery powder")?
3. If a meat or poultry product were comprised of both slaughtered meat or poultry and cultured animal cells, what unique labeling requirements, if any, should be required for such products?
4. What term(s), if used in the product name of a food comprised of or containing cultured animal cells, would be potentially false or misleading to consumers? For each term, please provide your reasoning.
5. What term(s), if used in the product name of a food comprised of or containing cultured animal cells, would potentially have a negative impact on industry or consumers? For each term, please provide your reasoning.
6. Should names for slaughtered meat and poultry products established by common usage (e.g., Pork Loin), statute or regulation be included in the names or standards of identity of such products derived from cultured animal cells?
   1. If so, is additional qualifying language necessary? What qualifying terms or phrases would be appropriate?
   2. Do these names, with or without qualifying language, clearly distinguish foods comprised of or containing cultured animal cells from slaughtered products?
7. Should terms that specify the form of meat or poultry products (such as "fillet", “patty” or "steak") be allowed to be included in or to accompany the name or standard of identity of foods comprised of or containing cultured animal cells?
   1. Under what circumstances should these terms be used?
   2. What information would these terms convey to consumers?
8. Should FSIS establish a regulatory standard of identity under its authorities in the FMIA and the PPIA (21 U.S.C. 607(c) and 457(b)) for foods comprised of or containing cultured animal cells?
   1. If so, what would be the standard and how might compliance with the standard be verified?
   2. If so, what would be the labeling terminology for products that do and do not meet a formal standard of identity? What would be the anticipated categories of use? For example, mechanically separated poultry that does not meet the standards of identity outlined in 9 CFR 381.173 may be diverted for production in broths and bases, as well as reaction flavors, i.e., flavors produced by the heating of the protein source in the presence of a reducing sugar.
   3. If so, what are the benefits and costs to industry if the standard of identity is established? Please provide quantitative and qualitative feedback in your response and explain the basis of any quantitative estimates.
   4. If so, what are the consumer benefits and costs to the standard of identity recommended?
9. What nutritional, organoleptic (e.g., appearance, odor, taste), biological, chemical or other characteristics, material to consumers’ purchasing and consumption decisions, vary between slaughtered meat or poultry products and those comprised of or containing cultured animal cells?
10. Should any of the definitions for “meat”, “meat byproduct” or “meat food product” found in 9 CFR 301.2 be amended to specifically include or exclude foods comprised of or containing cultured animal cells?
11. Should any of the definitions for “poultry product” or “poultry food product” found in 9 CFR 381.1 be amended to specifically include or exclude foods comprised of or containing cultured animal cells?
12. Should FSIS-regulated broths, bases and reaction flavors produced from cultured animal cells be required to declare the source material in the product name, ingredient sublisting or elsewhere on the label?
13. Should the presence of cultured animal cells in further processed products regulated by FSIS, such as a lasagna made with cell-cultured beef cells as an ingredient, be qualified on the product label? If so, how should this be qualified?
14. What label claims are likely to appear on FSIS-regulated products comprised of or containing cultured animal cells? Should FSIS develop new regulations or guidance on such claims to ensure they are neither false nor misleading?

See also: https://www.usda.gov/media/press-releases/2021/09/02/usda-seeks-comments-labeling-meat-and-poultry-products-derived

"Progresa en América Latina la Regulación del uso industrial de Cáñamo (Cannabis) en alimentos y suplementos"

 

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Introducción

Luego de 60 años de rechazo, de tres años de revisión científica de la OMS y de dos años de discusiones diplomáticas, el 2 de diciembre 2020, la ONU reconoció las propiedades terapéuticas de la flor de cannabis. Por decisión del organismo multilateral, el cannabis para uso medicinal fue retirado de la lista IV de la Convención sobre drogas de 1961.

Este avance ha permitido su despenalización para su uso terapéutico en varios países de Latinoamérica y, paralelamente, se ha identificado la extraordinaria versatilidad industrial del cáñamo no psicoactivo que consiste en aceites, resinas, tinturas, extractos crudos u otras innovaciones producto del desarrollo tecnológico, obtenidas del cannabis no psicoactivo o cáñamo, con un contenido de THC inferior al 1%, incluyendo, cannabinoides, isómeros, ácidos, terpenos, sales y sales de isómeros, obtenido del material vegetal como tallos, semillas, cáscaras de semillas, material leñoso, u otro material foliar como biomasa.

En la actualidad de es de gran interés el uso de los derivados  como materia prima en la industria alimentaria (ver Figura 1), una vez que se ha comprobado que las semillas de cáñamo y sus derivados (como el aceite, y la harina) presentan un contenido en: Ácidos grasos poliinsaturados (PUFAs) con bajas concentraciones de ácidos grasos saturados; Proteínas con un contenido excepcional de aminoácidos que contienen azufre, es decir, metionina, cisteína y arginina, además de su contenido de vitaminas y minerales, lo que le confiere un gran valor nutricional utilidad en la industria de alimentos. 

El reconocimiento de sus potencialidades para su uso en alimentos y suplementos es un tema que está actualmente en discusión, considerando que al ser productos destinados al consumo humano son de interés sanitario para las autoridades sanitarias nacionales y debe ser regulado. En este sentido, Latinoamérica presenta avances importantes en esta materia, países como Colombia, Ecuador, Uruguay, Chile o Paraguay han desarrollado con diferentes grados progresos o están desarrollando como Argentina, normativas que autorizan el uso industrial de cáñamo en alimentos, bebidas y suplementos alimenticios.

Ver artículo íntegro en:

https://www.academia.edu/50970297/Progresa_en_Am%C3%A9rica_Latina_la_Regulaci%C3%B3n_del_uso_industrial_de_C%C3%A1%C3%B1amo_Cannabis_en_alimentos_y_suplementos

Artículo seleccionado por:

Asociación Iberoamericana para el Derecho Alimentario

⚓ 7 de octubre de 2021 - Encuentro de Mejora: ¿CÓMO EXPORTAR ALIMENTOS A LA UNIÓN EUROPEA?

INSCRIPCIÓN:

https://docs.google.com/forms/d/e/1FAIpQLSeiIH5QihwSvbnKyMOYe8rveqBmbSJ0JumNx5bQmieuZBGORQ/viewform

proyectos@gwcertified.com - operaciones@gwcertified.com

 

✔️ 19 de octubre de 2021 - VIIº SEMINARIO INTERNACIONAL ALIMENTOS Y SALUD - UNA MIRADA AL FUTURO: SOSTENIBILIDAD, REGULACIONES Y TENDENCIAS

 

Fecha: 19 de octubre

Hora: 15:00 horas

Modalidad: Virtual

En el marco de la conmemoración de los 30 años de la Universidad ISALUD, la Maestría en Gestión de la Seguridad Alimentaria (MAGESA) lo invita a participar del VII° Seminario Internacional Alimentos y Salud “Una mirada al futuro: sostenibilidad, regulaciones y tendencias, una visión internacional”, que se desarrollará el martes 19 de octubre, 15 hs, en modalidad virtual.

El Seminario se desarrolla en el marco del convenio de cooperación entre la Universidad Católica San Antonio de Murcia (UCAM) de España y la Universidad ISALUD de Argentina, y forma parte del Ciclo de Seminarios “Alimentos y Salud” premiado por la Fundación ArgenINTA en la categoría “Campañas de difusión y educación que promuevan los hábitos saludables, la innovación y sustentabilidad agroalimentaria”.

 

                                                Inscripción: 

https://www.isalud.edu.ar/inscripcion-a-actividad/seminario_internaciona_alimentos_salud

Información: 

https://www.isalud.edu.ar/actividad/seminario_internaciona_alimentos_salud

🔴 USA - FDA Refuses to Approve CBD As a Food Ingredient or Supplement

The federal Food & Drug Administration (“FDA”) has refused to consider an application by Charlotte’s Web Holdings, Inc. (“Charlotte’s Web”) for a CBD product to be sold as a dietary ingredient. Instead of clarifying the uncertain legal environment around of the sale of CBD products intended for human and animal ingestion, the FDA’s inaction maintains the uncertainty.

The federal Food, Dug, and Cosmetic Act (the “FD&C Act”) requires that manufacturers and distributors who wish to market dietary supplements that contain “new dietary ingredients” (“NDI”) notify the FDA about these ingredients at least 75 days before the NDI or the product containing the NDI is sold in interstate commerce. The notification also must include information and evidence on which the manufacturer or distributor has based its conclusion that a dietary supplement containing the NDI will reasonably be expected to be safe under the conditions of use recommended or suggested in the labeling. Under the FD&C Act, the supplement containing the NDI is deemed to be “adulterated” unless there is a history of use or other evidence that the NDI, if used as recommended or suggested in the labeling, will reasonably be expected to be safe.

Charlotte’s Web submitted a notification to the FDA that it intended to market a NDI, namely a full-spectrum hemp extract in a dietary supplement tincture. Under the FDA rules, Charlotte’s Web also submitted information regarding the conditions of use, reports of safety studies, and other information that led them to conclude that the dietary supplement containing the tincture was reasonably expected to be safe.

The FDA responded that the hemp extract cannot be used in dietary supplements because the term “dietary supplement” excludes items or ingredients that have been approved as a new drug under the FDA regulations, and also excludes items or ingredients authorized for investigation as a new drug for which substantial clinical investigations have been instituted and made public, in both cases unless the item was marketed as a dietary supplement or a food before such approval. The FDA advised Charlotte’s Web that its proposed product was excluded from the definition of “dietary supplement” on both counts. CBD is the active ingredient in the drug Epidiolex, which has been approved for certain epilepsy treatments. In addition, the existence of substantial clinical investigations involving CBD has been made public. The FDA further determined that CBD was not marketed as a dietary supplement or conventional food before it was authorized for investigation as a new drug. As a result, the FDA concluded that Charlotte’s Web’s product could not be marketed as or in a “dietary supplement”.

The FDA response went on to advise Charlotte’s Web that, even if the product were not excluded from the definition of a “dietary supplement,” the FDA had questions about the evidence Charlotte’s Web had submitted. In particular, the response expressed concerns about the evidence of history of use, the adequacy of underlying data contained in other studies cited by Charlotte’s Web, and the lack of evidence on hepatotoxicity and reproductive toxicity.

The FDA’s continued refusal to take action to regulate CBD products for human and animal consumption leaves the entire industry in a legal grey area and continues to cause confusion in the marketplace as to the legal status of CBD products. There is legislation pending in Congress that would instruct the FDA to regulate hemp-derived CBD like all other new dietary ingredients, foods, and beverages.

WRITTEN BY: 

ARGENTINA: New resolution on geographical indications and appellations of origin

 

Existing regulations

Law 25,163 and Law 25,380 govern the following matters, respectively:

• geographical indications and appellations of origin for wines and wine-based spirits; and
• geographical indications and appellations of origin for agricultural and food products.

Law 25,380 sets out the two categories (ie, geographical indications and appellations of origin) as follows.

Section 1: The Geographical Indications and Appellations of Origin used for commercializing agricultural or food products either in their natural state, or conditioned or processed, shall be governed by the present law. Wines and wine-based spirits are excluded from this law and are regulated by a special regime.

Section 2: For the purposes of this law, the definitions shall be as follows:

a) Geographical Indication: The geographical name of a country, region, province, department, town, or area within its territory, which is known as place of extraction, production, or manufacturing of an agricultural or food product.

b) Appellation of Origin: The name of a region, province, department, district, town, or area within the national territory that is duly registered and is used for designating a product originating therein, and whose properties or characteristics are exclusively or essentially due to the geographical environment, which comprises natural and human factors.

Section 23 of Decree 274/2019 (related to unfair competition) provides as follows:

Prohibition of use: notwithstanding the provision of Laws Nos. 22,362 and its amendments, 24.425, 25,163, 25,380 and its amendment, and 26,355, a national or foreign appellation of origin shall not be used for identifying a product or service, if this product or service does not come from the respective zone. For this purpose, appellation of origin shall be understood as the geographical designation of a country, of a region or a specific place, which serves for designating a product or service originating therein, and whose particular properties or characteristics are due –exclusively or essentially- to the geographical environment, including both natural and human factors.

New resolution

In January 2021 the Secretariat for Food, Bioeconomy and Regional Development of the Ministry of Agriculture, Livestock and Fisheries issued Resolution 13/2021. This resolution updates the requirements for the recognition of geographical indications and appellations of origin of agricultural and food products, the registry in charge and the functions thereof. The resolution also includes a glossary of terms, which expressly states that geographical indications and appellations of origin of wines and wine-based spirits are governed by Law 25,163 and are therefore excluded from the new resolution.

For further information on this topic please contact Daniel R Zuccherino at Obligado & Cia by telephone (+54 11 4114 1100) or email (dzuccherino@obligado.com.ar). The Obligado & Cia website can be accessed at www.obligado.com.

Reminder: Opportunity to comment on draft “healthy” symbols for FDA’s planned consumer research

 The U.S. Food and Drug Administration (FDA) has released draft options for a new voluntary “healthy” symbol for packaged foods to depict the nutrient content claim.

Draft “healthy” symbols for planned consumer research

As previously noted, on 7 May 2021 the FDA issued a notice that it intends to conduct preliminary consumer research on symbols that could be used voluntarily to convey that the nutrient content of a packaged food is “healthy.”[1] One of the appendices to the notice includes draft “healthy” symbols for this planned testing, which are copied below.  

In addition to the colored symbols pictured above, the FDA also plans to test black and white versions. The FDA also intends to test a “no information” condition where no explanation of the symbol is provided, as well as a Uniform Resource Locator (URL) condition, in which a URL is tested alongside the symbol, presumably to provide additional information explaining the meaning of the symbol.

These symbols would be included voluntarily on packaged foods that meet the “healthy” criteria that the FDA is in the process of updating as part of the agency’s Nutrition Innovation Strategy. Although the notice itself is a fairly standard procedural notice, it provides a good opportunity to comment on the draft symbols as well as the limited details the FDA has released regarding the planned consumer research. Comments are due Tuesday, 6 July 2021.

Next steps    

We will continue to monitor developments related to nutrient content claims, the voluntary “healthy” symbols, and the Nutrition Innovation Strategy.

References 

1    Hogan Lovells, FDA to test voluntary “healthy” symbols through consumer research (7 May 2021) available at: https://www.engage.hoganlovells.com/knowledgeservices/news/fda-to-test-voluntary-healthy-symbols-through-consumer-research.

WRITTEN BY:

Hogan Lovells

[View source.]

Anneke Baran Altieri

Veronica Colas

Martin Hahn

Joseph Levitt