UNIT 2 (240) Flashcards
(19 cards)
Legal Categories of Food Substances
Food Additives (Direct & Indirect)
Color Additives
Generally Recognized as Safe (GRAS)
Prior-Sanctioned Substance
Food Additives
Any substance added to a food - Any substance used in the production, processing, treatment, packaging, transportation or storage of food
Direct additives are substances added to foods for a specific reason
6 Main Reasons for Adding Direct Additives
Product Consistency: Emulsifiers, thickeners, anti-caking agents
Improve or maintain nutritional value: Vitamins, minerals
Maintain safety and wholesomeness of food: Preservatives (Potassium Sorbet and Sodium Benzoate) & Antioxidants (BHT and BHA)
Leavening agents: Baking powder
Control of acidity and alkalinity: Citric acid
Enhance flavor: Spices
Indirect Additives
Become part of the food in trace amounts due to its packaging, storage or often handling
Packaging substances may find their way into foods during storage
All materials that come in contact with food must be safe
Bisphenol A (BPA)
Used in the manufacturing of polycarbonate bottles (water bottles) and epoxy-based enamels coatings in cans (aluminum, tin) and can migrate from packaging into foods
Some evidence shows that BPA is associated with heart disease, diabetes, breast cancer, and obesity
BPA has been shown to have estrogenic activity
Currently, FDA recognizes that there is some concern for the potential effects of BPA on brain, behavior, and prostate gland in fetuses, infants, and children
No ban has been put in place, but FDA is supporting continued research at their Center for Toxicological Research
FDA is supporting industry actions to stop producing BPA-containing infant bottles and infant feeding cups
FDA is not recommending that families change the use of infant formula or foods, as the benefit of a stable source of good nutrition outweighs the potential risk from BPA exposure
Food Defect Action Levels
Establishes MAXIMUM levels of natural or unavoidable defects in foods for human use that present no health hazard
Color Additives
Any dye, pigment or substance that impart color when added or applied to a food, drug, or cosmetic, or to the human body
All color additives permitted for use in foods are classified as “certifiable” or “exempt from certification”
Certifiable Colors
Manmade (FD&C Yellow No. 6)
Exempt from Certification
Pigments derived from natural sources such as vegetables, minerals or animals (Beta-carotene, titanium dioxide, cochineal from beetles)
Cochineal Extract (Carmine)
Natural additive that is produced from ground up beetles
Used in both food and in cosmetics (lipstick)
New labeling law states that by January 2011 all food and cosmetic product must label carmine or cochineal extract on their label
Severe allergic reaction including anaphylaxis have been reported
Color Additives and Hyperactivity
Studies have shown increased hyperactivity in children as a result of consuming beverages with food coloring
FDA has not issues such legislation for the US with regard to color additives and hyperactivity
Generally Recognized as Safe
Substances added to foods that have been shown to be safe based on a long history of common usage in foods (e.g. salt)
Not an inherent property of a substance, but must be assessed in the context of the intended conditions of use of the substance
Purpose is to recognize the safety of basic substance without the requirement for rigorous safety testing
(Don’t generally test for safety)
Prior-Sanctioned Substance
Substances that were determined to be safe by the FDA and USDA prior to the passage of the 1958 Food Additives Amendment (Grandfathered in)
Examples: Sodium nitrate and potassium nitrate (used to preserve luncheon meats, hotdogs, bacon)
Nitrates
Used to prevent growth of C. Botulinum spores and maintain pink color of meats
Health Concerns: Meats containing nitrates that are heated at high temperatures can form nitrosamines (Burnt Bacon), which are carcinogenic
Recommended to cook these meats at a lower temperature for longer time
Nitrates can also be found at high levels in spinach, beets, radishes, cabbage, and also drinking water
Approval of New Food Substances
FDA must approve all new food additives (indirect, direct), color additives, and new GRAS substances
Approval is not required for prior approved substances and those which are already considered GRAS
Manufacturers must provide FDA with evidence that substance not only performs its intended function, but also is not harmful at expected consumption levels
FDA determines the types of foods that may contain the additive, quantities (max levels), and the way the substance is identified on labels
Foods containing non-approved additives are considered adulterated, and FDA will take action on those products
Delaney Clause
1958 amendment to Food, Drug and Cosmetic Act of 1938
Food and color additives cannot be approved if they cause cancer in humans or animals
(Animal feeding studies with extremely high doses is a method used to determine if a substance is carcinogenic
Saccharin
1977 - A study was conducted that showed that feeding rats the amount of saccharin equivalent to 800 diet sodas daily for their entire life caused bladder cancer
FDA proposed a ban on Saccharin, but after public outcry Congress used its authority to prevent the ban until fourth evidence was obtained
1991 - The proposal to ban was removed by FDA after mechanistic studies showed that the bladder cancer development is specific to rats
Dietary Supplements
Defined by Congress in the Dietary Supplement Health and Education Act (DSHEA) of 1994
Any product, taken by mouth, intended to supplement the diet
Include: Vitamins, minerals, herbs or other botanicals, amino acids, and substances such as enzymes, organ tissues, glandular, and metabolites
Dietary Supplement Regulations
Are not food additives and do not have the same regulations as food additives
Manufacturers are responsible for determining that their product is safe and that any representations or claims made about them are substantiated by adequate evidence to show that they are not false or misleading
Manufacturers of dietary supplements that were not on the market prior to 1994 are required to notify FDA 75 days before marketing
The notification must show that substance is safe - there is no wording in the legislation that FDA’s approval is required
FDA is responsible for showing that a dietary supplement is unsafe before it can take action to restrict the product’s use or remove from the marketplace
