Certificate Type:

Landfood:  Conventional foods for human consumption are foods that are not seafood, infant formula, or dietary supplements.

Seafood:  All aquatic animal life, other than birds and mammals, that is used as food for human consumption. For example, in addition to fresh and saltwater finfish and crustaceans, this applies to echinoderms such as sea cucumbers and sea urchins; reptiles such as alligators and turtles; amphibians such as frogs; and to all mollusks, including land snails (escargot). It also applies to extracts and derivatives of fish, such as eggs (roe), oil, cartilage, and fish protein concentrate, products that are mixtures of fish and non-fish ingredients, such as tuna sandwiches and soups.

Food Additive:  This certificate type applies to any substance the intended use of which results or may reasonably be expected to result in its becoming a component or otherwise affecting the characteristic of any food.

Food Contact Substances:  This certificate type applies to any substance that is intended for use as a component of materials used in manufacturing, packing, packaging, transporting, or holding food if such use of the substance is not intended to have any technical effect in such food.

Dietary Supplements:  The term "dietary supplement" is defined in the Federal Food Drug and Cosmetic Act, as amended by the Dietary Supplement Health and Education Act of 1994, as a product (other than tobacco) intended to supplement the diet that bears or contains a vitamin, a mineral, an herb or other botanical, an amino acid, a dietary substance for use by man to supplement the diet by increasing the total dietary intake, or a concentrate, metabolite, constituent, extract, or combination of any of the above ingredients (21 U.S.C. 321(ff)(1)). Moreover, to be a dietary supplement, a product must be intended for ingestion in a form described in 21 U.S.C. 350(c)(1)(B)(i) or comply with 21 U.S.C. 350(c)(1)(B)(ii), must not be represented as conventional food or as a sole item of a meal or the diet, and must be labeled as a dietary supplement (21 U.S.C. 321(ff)(2)). The definition excludes an article that is authorized for investigation as a new drug, antibiotic, or biological for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public, which was not before such authorization marketed as a dietary supplement or as a food (21 U.S.C. 321(ff)(3)(B)(ii)).

Infant Formula:  Infant formula is defined by section 201(z) of the act, 21 USC 321(z), as "a food which purports to be or is represented for special dietary use solely as a food for infants by reason of its simulation of human milk or its suitability as a complete or partial substitute for human milk." The term "infant" is defined as "persons not more than 12 months old" (21 CFR 105.3). Toddler formulas are not considered infant formulas unless they are also intended for children of less than one year of age; in that case they will be regulated as infant formula. A medical food that is also an infant formula will be regulated as an infant formula. Human milk fortifiers are considered to be infant formula. Foods intended for infants such as juices, pureed baby food and baby cereals are regulated as foods not as infant formula.

Medical Foods:  The Orphan Drug Amendments of 1988 enacted, for the first time, a statutory definition of medical food. The term medical food means a food which is formulated to be consumed or administered enterally under the supervision of a physician and which is intended for the specific dietary management of a disease or condition for which distinctive nutritional requirements, based on recognized scientific principles, are established by medical evaluation. Medical foods are distinguished from the broader category of foods for special dietary use and from foods that make health claims by the requirement that medical foods be intended to meet distinctive nutritional requirements of a disease or condition, used under medical supervision, and intended for the specific dietary management of a disease or condition. Medical foods are not those simply recommended by a physician as part of an overall diet to manage the symptoms or reduce the risk of a disease or condition, and all foods fed to sick patients are not medical foods. Instead, medical foods are foods that are specially formulated and processed (as opposed to a naturally occurring foodstuff used in a natural state) for a patient who is seriously ill or who requires use of the product as a major component of a disease or condition's specific dietary management.FDA established criteria that clarify the statutory definition of a medical food at 21 CFR 101.9(j)(8). A food is a medical food and is exempt from the nutrition labeling requirements of 21 CFR 101.9 only if:(i) It is a specially formulated and processed product (as opposed to a naturally occurring foodstuff used in its natural state) for the partial or exclusive feeding of a patient by means of oral intake or enteral feeding by tube;(ii) It is intended for the dietary management of a patient who, because of therapeutic or chronic medical needs, has limited or impaired capacity to ingest, digest, absorb, or metabolize ordinary foodstuffs or certain nutrients, or who has other special medically determined nutrient requirements, the dietary management of which cannot be achieved by the modification of the normal diet alone; (iii) It provides nutritional support specifically modified for the management of the unique nutrient needs that result from the specific disease or condition, as determined by medical evaluation; (iv) It is intended to be used under medical supervision; and (v) It is intended only for a patient receiving active and ongoing medical supervision wherein the patient requires medical care on a recurring basis for, among other things, instructions on the use of the medical food.

Food for Special Dietary Use:  In the Federal Register of November 22, 1941 (6 FR 5921), FDA promulgated a regulation stating that the term special dietary uses'', as applied to food for man, means particular (as distinguished from general) uses of food, and that it means, among other things, uses for supplying particular dietary needs which exist by reason of a physical, physiological, pathological or other condition, including but not limited to the conditions of disease,convalescence, pregnancy, lactation, allergic hypersensitivity to food, underweight, and overweight. This part of the regulation remains unchanged in current Sec. 105.3(a)(1) (21 CFR 105.3(a)(1)). The statutory definition of special dietary use in section 411(c)(3) of the act (21 U.S.C. 350(c)(3)) was added in 1976 (Pub.L. 94-278).§ 105.3 Definitions and interpretations.The definitions and interpretations of terms contained in section 201 of the Federal Food, Drug, and Cosmetic Act (hereafter "the act") shall be applicable with the following additions:(a)(1) The term special dietary uses, as applied to food for man, means particular (as distinguished from general) uses of food, as follows: (i) Uses for supplying particular dietary needs which exist by reason of a physical, physiological, pathological or other condition, including but not limited to the conditions of diseases, convalescence, pregnancy, lactation, allergic hypersensitivity to food, underweight, and overweight;(ii) Uses for supplying particular dietary needs which exist by reason of age, including but not limited to the ages of infancy and childhood; (iii) Uses for supplementing or fortifying the ordinary or usual diet with any vitamin, mineral, or other dietary property. Any such particular use of a food is a special dietary use, regardless of whether such food also purports to be or is represented for general use.

Cosmetics:  Articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance, and articles intended for use as a component of any such articles; except that such term shall not include soap (soap is defined in the Code of Federal Regulations at 21 CFR 701.20).