The U.S. Food and Drug Administration today announced it has completed its evaluation of a variety of pineapple genetically engineered by Del Monte Fresh Produce (DMFP) to have pink flesh, concluding that there are no unresolved safety or regulatory questions about the pineapple. DMFP submitted information to the agency to demonstrate that the pink flesh pineapple is as safe and nutritious as its conventional counterparts. DMFP’s new pineapple has been genetically engineered to produce lower levels of the enzymes already in conventional pineapple that convert the pink pigment lycopene to the yellow pigment beta carotene. Lycopene is the pigment that makes tomatoes red and watermelons pink, so it is commonly and safely consumed.
In addition, after consulting with the FDA, DMPF plans to identify the food as “extra sweet pink flesh pineapple” on tags attached to the crown of the fruit. This will distinguish the pink flesh pineapple from DMFPs golden” extra sweet pineapple” which was introduced in the 1990s. Other companies interested in marketing the pink flesh pineapple are advised to consult with CFSAN’s Office of Nutrition and Food Labeling, to discuss any required or voluntary labeling, including statements relating to attributes of these pineapples or any type of claim.
DMFP participated in a voluntary consultation with FDA’s Office of Food Additive Safety about the pineapple. During that consultation, DMFP submitted information to FDA scientists regarding characteristics of the new plant variety, the nature and effect of the genetic change, potential unexpected or unintended effects that could accompany the genetic change, and the nutritional assessment. After review of that data FDA scientists concluded that there were no unresolved safety or regulatory issues under the Federal Food, Drug, and Cosmetic Act (FD&C Act) for the genetically engineered pink flesh pineapple.
A consultation is not synonymous with FDA approval. Rather, it is voluntary and helps developers of food ensure that foods derived from new plant varieties are safe and comply with the FD&C Act and FDA’s regulations.
Although DMFP will market this pineapple in the United States, they are not planning on growing it here. The company is working with the government of Costa Rica on this matter.
EF2-114, Pineapple with altered color containing lycopene and reduced ripening
The intended effects of the modifications in EF2-114 pineapple are to alter the color of the fruit to pink from yellow through accumulation of lycopene in place of β-carotene and to alter flower control. To accomplish this objective, DMFPC introduced genetic material for:
- One gene (psy) encoding the phytoene synthase (PSY) protein, which is involved in a key step in lycopene synthesis
- Two RNAi constructs (bLcy and eLcy) intended to suppress endogenous expression of two genes (lycopene β-cyclase and lycopene ε-cyclase) that convert lycopene to other carotenoids
- One RNAi construct (flACC3ʹ) intended to suppress flowering by suppressing endogenous expression of 1-aminocyclopropane-1-carboxylic acid synthase, the penultimate step in ethylene biosynthesis
Full Biotechnology Consultation File Link
Del Monte Fresh Produce Company Letter
This letter addresses Del Monte Fresh Produce Company’s (DMFPC) consultation with the Food and Drug Administration (FDA) (Center for Food Safety and Applied Nutrition (CFSAN) and Center for Veterinary Medicine (CVM)) on genetically engineered pineapple, transformation event number EF2-114 (EF2-114 pineapple). According to information DMFPC has provided, EF2-114 pineapple is genetically engineered to have altered color. To achieve the altered color, DMFPC introduced a gene encoding phytoene synthase protein, involved in lycopene synthesis and RNA interference (RNAi) constructs intended to suppress endogenous expression of lycopene β-cyclase and lycopene ε-cyclase, which both convert lycopene to other carotenoids. DMFPC also introduced an RNAi construct intended to control flowering by suppressing endogenous expression of 1-aminocyclopropane-1-carboxylic acid synthase, which leads to ethylene biosynthesis. All materials relevant to this consultation have been placed in a file designated BNF 000149. This file will be maintained in the Office of Food Additive Safety in CFSAN.
As part of bringing this consultation to closure, DMFPC submitted to FDA a summary of its safety and nutritional assessment of the genetically engineered pineapple, which FDA received on February 15, 2015. DMFPC submitted additional information, received by FDA on January 18, 2016, and August 24, 2016. These communications informed FDA of the steps taken by DMFPC to ensure that this product complies with the legal and regulatory requirements that fall within FDA’s jurisdiction. DMFPC states that the pineapples will be grown outside of the United States (in Costa Rica). DMFPC does not intend for EF2-114 pineapples to be used in food for animals in the United States. Based on the safety and nutritional assessment DMFPC has conducted, it is our understanding that DMFPC concludes that human food from EF2-114 pineapple is not materially different in composition, safety, and other relevant parameters from pineapple-derived food currently on the market except for the intended pigment changes in EF2-114 pineapple. DMFPC also concludes that genetically engineered EF2-114 pineapple does not raise issues requiring premarket review or approval by FDA.
As always, it is a producer’s or distributor’s responsibility to ensure that labeling of the foods it markets meets applicable legal requirements. You stated that you intend to identify the food as “Extra Sweet Pink Flesh Pineapple.” We agree that this name is an accurate description of the EF2-114 pineapple. Companies marketing EF2-114 pineapples are advised to consult with CFSAN’s Office of Nutrition and Food Labeling, Food Labeling and Standards Staff, to discuss any required or voluntary labeling including statements relating to attributes of these pineapples or any other type of claim.
Finally, on July 29, 2016, the National Bioengineered Food Disclosure Law (Public Law 114-216) charged the United States Department of Agriculture’s Agricultural Marketing Service with developing a national mandatory system for disclosing the presence of bioengineered material in human food. Producers, distributors, and marketers of EF2-114 pineapple are responsible for following the requirements issued by USDA relevant to the labeling of their products.
Because EF2-114 pineapples will not be grown in the United States and pineapples and pineapple by-products are not significant ingredients in animal food in the United States, CVM concluded that an in-depth evaluation for use in animal food was not warranted.. Based on the information DMFPC has presented to FDA, we have no further questions concerning human food derived from EF2-114 pineapple at this time. However, as you are aware, it is DMFPC’s continuing responsibility to ensure that foods marketed by the firm are safe, wholesome, and in compliance with all applicable legal and regulatory requirements. A copy of the text of this letter responding to BNF 000149, as well as a copy of the text of FDA’s memorandum summarizing the information in BNF 000149, is available for public review and copying at http://www.fda.gov/bioconinventory.