Application of Biotechnology for Functional Foods

The application of biotechnology to foods expressly to improve nutritional and health characteristics holds great potential, as demonstrated by many research accomplishments. Food enhancements cover a wide range, including improved fatty acid profiles for more heart healthy food oils, improved protein content and quality for better human and animal nutrition, increased vitamin and mineral levels to overcome widespread nutrient deficiencies throughout the world, and reduction in anti-nutritional substances that diminish food quality and can be toxic. On the horizon are efforts to increase the concentration of various antioxidants and functional substances such as phytosterols and probiotic bacteria. Improvements in the digestibility of animal feed through the reduction of phytic acid, gossypol and glycoalkaloids also have potential to enhance the safety of human foods. Although biotechnology has made some advances in reducing allergenic proteins in some foods, the complexity of allergenic responses, differences in sensitivity among people, and the presence of multiple allergens in a single food make this challenge particularly daunting. It appears that food oils with improved fatty acid profiles are the closest to reaching commercialization, once regulatory clearance has been obtained.

Just what form those regulatory clearances may take is not entirely certain. There is no regulatory scheme for functional food, per se, but functional food products are clearly subject to federal regulation. If a functional food product is marketed for a therapeutic purpose (e.g., to treat a disease), it will be subject to regulation as a “drug.” If a product is subject to regulation as a “food,” it may be further classified as a conventional food, dietary supplement, food for special dietary use (including infant formula), or medical food, again depending upon its intended use and other factors.

How a product is categorized has substantial implications for how it is marketed, the safety and labeling standards it must meet, and what requirements it must address for regulatory review and clearance or approval. A conventional food may be freely marketed on the basis of taste, and enjoys some flexibility regarding certain types of claims, such as structure/function claims, which need not be presubmitted to FDA nor accompanied by a disclaimer. Conventional food, including food ingredients, however, must meet safety standards requiring a “reasonable certainty of no harm.” The safety standard for dietary supplements is less stringent, but supplements are restricted to marketing in certain forms (e.g., as a tablet or powder, and in some circumstances, as a bar or liquid), and can make structure/function claims only if such claims are submitted to FDA and accompanied by the DSHEA disclaimer.

Food for special dietary use enjoys some flexibility as to nutrient content and health claim requirements, but the extent of this flexibility, and of the special dietary use category itself, is unclear and probably very fact-specific. Medical food is entitled to the most flexibility of all, but is permitted in extremely narrow and carefully defined circumstances. Certain food products, including meat and poultry, egg products, and animal feed, including pet food, are theoretically eligible for marketing in a functional food form. Such products are, however, subject to distinct regulatory requirements and oversight that may limit functional food opportunities as a practical matter. Animal feed, in particular, has been regulated by CVM in a manner that restricts the types of ingredients and promotional claims that may be used, despite the statutory classification of animal feed as “food.” The use of modern biotechnology to enhance human and other animal food will likely not change these regulatory paradigms, but may challenge the boundaries of some of the regulatory classifications.

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