‘You’d be surprised!’: Groceries banned overseas for health concerns still on US store shelves

DEDHAM, Mass. — If you take a look around your kitchen, you’ll likely see a variety of foods you love to eat. Many of those foods probably include chemicals that are banned in other countries due to health concerns.

Some companies even make two versions of their products—one without these additives that are sold in Europe and another with additives that are sold in the United States.

Scott Faber works with the Environmental Working Group (EWG) to track the use of food additives worldwide.

"Many of the chemicals that are in your food, if they have been reviewed by the FDA, have not been reviewed for 40 or 50 years," Faber said "As you can imagine, there's been a lot of scientific developments and changes in how we use these chemicals."

The Federal Drug Administration has not reviewed those ingredients because, in 1966, it deemed hundreds of additives as ‘Generally Recognized As Safe’ or GRAS. The "GRAS list" keeps growing and now there are about a thousand. The EWG highlighted the most common additives on the GRAS list that are banned in other countries.

Brominated vegetable oil

Propylparaben

Potassium bromate

Titanium dioxide

The Environmental Working Group has an easy search function on its website (https://www.ewg.org/foodscores/) It gives each product a rating from 1 to 10, ten being the highest concern. The number is based on nutrition, ingredients, and processing. You can click on ingredients and find the exact chemicals in the product.

When asked about this report, the FDA sent the statement below:

"Regulatory authorities across the globe have different legal authorities and regulatory programs. It is not uncommon for a substance to be approved in one jurisdiction but not in another. For example, there are color additives that are authorized for use in Europe and elsewhere but are not authorized in the U.S. We also note that other international regulatory bodies including the United Kingdom's FSA, Health Canada, and Food Standards Australia New Zealand (FSANZ) have not agreed with the European Union assessment regarding titanium dioxide. Review of titanium dioxide as a food additive (foodstandards.gov.au)

The FDA evaluates and regulates ingredients added to food to ensure that the authorized use of these ingredients is safe. Specifically, food additives and color additives require pre-market review and approval by the FDA before they can be added to food. To obtain this authorization, a manufacturer is required to supply the FDA with evidence that establishes each food or color additive is safe under its intended conditions of use. In the case of food or color additives, manufacturers submit data and information to the FDA as a petition requesting approval of the ingredient for the specific intended use(s). The submitted information includes data pertaining to the identity of the substance, its method of manufacturing, purity, intended food categories, an amount expected to be consumed (dietary exposure), and laboratory studies supporting safety. The FDA evaluates the petition and other existing data and information to determine if the data available demonstrate that the substance is safe under the intended conditions of use. If the FDA determines that the intended use of the additive is safe, the FDA publishes a regulation authorizing its use as a food additive or color additive.

The definition of food additive in the Federal Food, Drug, and Cosmetic Act includes a provision for the use of substances that are Generally Recognized as Safe (GRAS) (there is no such provision for color additive uses). For the use of a substance to be considered GRAS, all data necessary to establish safety must be publicly available and its safe use must be generally recognized by qualified experts. In addition, GRAS users must meet the same safety standard as for food additives, a reasonable certainty of no harm under the conditions of its intended use, and have the same quantity and quality of information that would support the safety of a food additive. The FDA has established a GRAS notification program to help ensure that these substances are safe under their intended use and to help the industry meet its responsibility for ensuring the GRAS status of substances they intend to use in food. Food manufacturers that have concluded that the intended uses of a substance meet the GRAS standards can submit a notice and receive a response letter from FDA on the manufacturer's safety conclusion. The FDA strongly encourages food manufacturers to contact the agency and follow the available procedures for our oversight of GRAS conclusions by participating in our GRAS Notification Program.

The FDA has evaluated more than 1,000 GRAS Notices since the beginning of the GRAS Notification Program in 1997. We may determine that the use of a substance is not generally recognized as safe and require FDA approval as a food additive.

In addition to our GRAS Notification Program, we also proactively support efforts to aid the industry in complying with the law (the FD&C Act). For example, we recently published a final guidance document (Guidance for Industry: Best Practices for Convening a GRAS Panel | FDA). This document provides guidance to industry on best practices to follow when convening a panel of experts to evaluate whether a substance is "generally recognized as safe" (GRAS) under the conditions of its intended use and addresses topics such as identifying appropriate experts, reducing the risk of bias, and how to ensure that all data and information provided to the panel are publicly available. We also have issued numerous other guidance documents to clarify the regulations for GRAS.

Although the FDA monitors, evaluates, and regulates ingredients added to food to ensure that the authorized use of these ingredients is safe, it's important to underscore that food manufacturers are responsible for marketing safe foods. The food industry has a legal responsibility to ensure the safety of the ingredients they use in foods before they go to market. The safety of food additives must be supported by science that demonstrates its use meets the FDA's safety standards. The same safety standards and required evidence apply to uses of ingredients that are considered generally recognized as safe.

The FDA assists the food industry to meet its legal obligation to market safe foods through our regulations, guidance documents, and regulatory programs. When a substance added to food is not GRAS (and is not otherwise excepted from the definition of a "food additive") and is not approved as a food additive under the conditions of its intended use, the FDA can take various actions, including issuing a warning letter (which we make public on our web site, fda.gov) to companies that manufacture or distribute the food additive and/or food containing the food additive; issuing a public alert; and taking enforcement action to stop distribution

of the food substance and foods containing it on the grounds that such foods are or contain an unlawful food additive.

Titanium dioxide is regulated by the FDA as a color additive. The FDA has several authorizing color additive regulations for titanium dioxide, for use in food, drugs, cosmetics, and medical devices. The regulations are here: CFR – Code of Federal Regulations Title 21 (fda.gov), CFR – Code of Federal Regulations Title 21 (fda.gov), CFR - Code of Federal Regulations Title 21 (fda.gov), and here: CFR - Code of Federal Regulations Title 21 (fda.gov). The FDA is aware of recent actions taken by the European Union regarding use of titanium dioxide as a color additive. We note that other international regulatory bodies including the United Kingdom's FSA, Health Canada, and FSANZ have not agreed with the European Union assessment. Review of titanium dioxide as a food additive (foodstandards.gov.au)

Potassium bromate has been used as a bread dough conditioner since 1916, as permitted by the FDA's standards of identity for bromated flour used for various types of bread, rolls, and buns. When food manufacturers use potassium bromate properly, potassium bromate converts to harmless potassium bromide in the finished food product. The FDA has worked with the American Baker's Association (ABA) to help the industry improve baking technology and testing so that the ingredient is used in a way that results in no or minimal detectable residual bromate. ABA has indicated that normal control measures can ensure that bromate residues are well below 20 ppm. In addition, we note that recent label surveys indicate that the ingredient is no longer widely used by the baking industry.

Brominated vegetable oil (BVO) is regulated as a food additive. Based on early toxicological data, the FDA took action in 1970 to limit consumer exposure by removing BVO from the list of codified GRAS substances and allowing for only one use in food—as a stabilizer for flavoring oils in fruit-flavored beverages at levels not to exceed 15 parts per million in the finished beverage (CFR - Code of Federal Regulations Title 21 (fda.gov)). For more information, see Brominated Vegetable Oil (BVO) | FDA.

Propylparaben is also known as propyl p-hydroxybenzoate. Propylparaben is regulated as a food additive for use as a flavoring agent (CFR - Code of Federal Regulations Title 21 (fda.gov)) and as a substance affirmed as generally recognized as safe for use as an antimicrobial agent (CFR - Code of Federal Regulations Title 21 (fda.gov)).

We also make regulatory information about these substances available to the public in our inventories of food ingredients in the U.S. food supply: Food Ingredient and Packaging Inventories | FDA, including the public Search Food Ingredient and Packaging Inventories (fda.gov)."

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