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The U.S. Food and Drug Administration (FDA) recently evaluated two types of Okanagan Specialty Fruits, Inc.’s genetically engineered apples and six types of J. R. Simplot Company’s genetically engineered potatoes. Okanagan reduced the levels of enzymes in its apples that cause browning associated with cuts and bruises.  J.R. Simplot reduced enzymes in its potatoes to help resist black bruise spots, as well as engineered the potatoes to produce less acrylamide, a chemical found to be carcinogenic in rodents.  On March 20, 2015, FDA announced that it had “concluded that these foods are as safe and nutritious as their conventional counterparts.”

Genetic engineering, also known as biotechnology, refers to methods used by scientists to modify the traits or characteristics of an organism.  According to FDA, genetically engineered plants have been part of our food supply since the 1990s. Genetically engineered food and food ingredients must comply with the same FDA regulations and safety standards as other food.  FDA offers a voluntary biotechnology consultation process to help manufacturers ensure their genetically modified foods are safe and compliant.  According to Dennis Keefe, director of FDA’s Office of Food Additive Safety, “the consultation process includes a review of information provided by a company about the nature of the molecular changes and the nutritional composition of the food compared to traditionally bred varieties.”

FDA has completed approximately 166 biotechnology consultations to date.  FDA has found that, when compared to foods derived from traditionally bred plants, genetically engineered foods are generally equally nutritious and do not pose a greater risk for allergic or toxic reactions.

Currently, there is no FDA requirement for food manufacturers to indicate whether food has been genetically engineered on product labels.  FDA is in the process of reviewing two citizen petitions requesting that the agency change its labeling requirements for genetically engineered foods.  For the time being, food manufacturers can voluntarily include this information on labels.

In 2001, FDA published a voluntary labeling guidance to assist manufacturers of genetically engineered food in determining what information is required and what information is optional.  The guidance states that under section 201(n) of the Food, Drug, and Cosmetic Act (FD&C Act), FDA requires food labels to disclose all material facts about the food and thus:

  • If a bioengineered food is significantly different from its traditional counterpart such that the common or usual name no longer adequately describes the new food, the name must be changed to describe the difference.
  • If an issue exists for the food or a constituent of the food regarding how the food is used or consequences of its use, a statement must be made on the label to describe the issue.
  • If a bioengineered food has a significantly different nutritional property, its label must reflect the difference.
  • If a new food includes an allergen that consumers would not expect to be present based on the name of the food, the presence of that allergen must be disclosed on the label.

The guidance also helps manufacturers determine proper language for labeling their products as being genetically engineered as to not be misleading.  FDA has found that consumers prefer the term “biotechnology” over “genetic modification” or “genetic engineering”, and they prefer to know why genetic engineering was used on the product (increased nutrition, resistance to discoloration, etc.).  So, a preferable statement to identify a genetically engineered food could be: “This product contains corn developed using biotechnology to increase resistance to insects.”

FDA warns that the amount of a genetically engineered ingredient within a food item can determine whether a statement is misleading.  For example, FDA may consider it misleading to state that a food includes nutritionally improved soybeans if the soybeans make up only a small portion of the ingredients.

Registrar Corp helps food and beverage manufacturers comply with U.S. FDA regulations.  Registrar Corp’s Label and Ingredient Review Specialists can review food labels for FDA compliance, including identifying statements that could be considered misleading to consumers.  For assistance with labeling or any other FDA regulations for food and beverage companies, contact Registrar Corp at +1-757-224-0177 or speak to a Regulatory Advisor 24 hours a day at www.registrarcorp.com/LiveHelp.

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Registrar Corp assists businesses with U.S. FDA compliance. Certificates of Registration issued by Registrar Corp provide confirmation to industry that you are fulfilling U.S. FDA registration requirements. U.S. FDA does not issue or recognize Certificates of Registration. Registrar Corp is not affiliated with the U.S. Food and Drug Administration.

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