In the first part, we discussed different agencies/organizations involved in the regulation of food safety in US. Basically we found that FDA and FSIS were the primary agencies and NFMS, EPA, CDS, DHS, APHIS etc were secondary agencies in terms of the responsibilities of food safety in USA. Click here to read the Part 1 of the series.
In this post, we will try to discuss on the FDA jurisdiction and authority.
The FDA is responsible for protecting and promoting public health through the control and supervision of food safety, tobacco products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), cosmetics, animal foods & feed and veterinary products.
In general, there are 4 categories of products regulated by US FDA: food & dietary supplement, cosmetic, drug and device. The fifth category is those not regulated by FDA. This classification is the heart of all the enforcement decision. Hence, let’s try to discuss and understand this classification better in both technical and legal terms.
The legal definition of food, food additive, dietary supplement and drug are as follows:
------------------------------- you can skip these legal definition, if you are not interested ----------------
"Section 201 (f) “food”: “food” means (1) articles used for food or drink for man or other animals, (2) chewing gum, and (3) articles used for components of any such article"
"Section 201(s) “food additive”: “food additive” means any substance the intended use of which results or may reasonably be expected to result, directly or indirectly, in its becoming a component or otherwise affecting the characteristics of any food (including any substance intended for use in producing, manufacturing, packing, processing, preparing, treating, packaging, transporting, or holding food; and including any source of radiation intended for any such use), if such substance is not generally recognized, among experts qualified by scientific training and experience to evaluate its safety, as having been adequately shown through scientific procedures (or, in the case of a substance used in food prior to January 1, 1958, through either scientific procedures or experience based on common use in food) to be safe under the conditions of its intended use; except that such term does not include—(1) a pesticide chemical residue in or on a raw agricultural commodity or processed food; or(2) a pesticide chemical; or(3) a color additive; or(4) any substance used in accordance with a sanction or approval granted prior to the enactment of this paragraph 4 pursuant to this Act [enacted Sept. 6, 1958], the Poultry Products Inspection Act (21 U.S.C. 451 and the following) or the Meat Inspection Act of March 4, 1907 (34 Stat. 1260), as amended and extended (21 U.S.C. 71 and the following);(5) a new animal drug; or(6) an ingredient described in paragraph (ff) in, or intended for use in, a dietary supplement"
"Section 201 (ff) “Dietary Supplement”: “dietary supplement”—(1) means a product (other than tobacco) intended to supplement the diet that bears or contains one or more of the following dietary ingredients:(A) a vitamin;(B) a mineral;(C) an herb or other botanical;(D) an amino acid;(E) a dietary substance for use by man to supplement the diet by increasing the total dietary intake; or(F) a concentrate, metabolite, constituent, extract, or combination of any ingredient described in clause (A), (B), (C), (D), or (E);(2) means a product that—(A) (i) is intended for ingestion in a form described in section 411(c)(1)(B)(i); or(ii) complies with section 411(c)(1)(B)(ii);(B) is not represented for use as a conventional food or as a sole item of a meal or the diet; and(C) is labeled as a dietary supplement; and(3) does—(A) include an article that is approved as a new drug under section 505 or licensed as a biologic under section 351 of the Public Health Service Act (42 U.S.C. 262) and was, prior to such approval, certification, or license, marketed as a dietary supplement or as a food unless the Secretary has issued a regulation, after notice and comment, finding that the article, when used as or in a dietary supplement under the conditions of use and dosages set forth in the labeling for such dietary supplement, is unlawful under section 402(f); and(B) not include—(i) an article that is approved as a new drug under section 505, certified as an antibiotic under section 507 7, or licensed as a biologic under section 351 of the Public Health Service Act (42 U.S.C. 262), or(ii) an article 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 approval, certification, licensing, or authorization marketed as a dietary supplement or as a food unless the Secretary, in the Secretary’s discretion, has issued a regulation, after notice and comment, finding that the article would be lawful under this ActExcept for purposes of section 201(g), a dietary supplement shall be deemed to be a food within the meaning of this Act"
"Section 201(g) (1)(c) : the term ‘drug’ means … (B) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals…(C) articles (other than food) intended to affect the structure or any function of the body of man or other animals.” Also called the “food exception,” it is the most cited defense to a drug classification of a food-based product claiming some drug-like effect."
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There were multiple incidences of ambiguity in the classification of product as food, food supplement and drug. There were multiple disputes between FDA and manufacturer in the product classification and for deciding the regulatory requirements. Such issues were challenged in the US court.
This confusion and ambiguity exists even in US where a single Food and Drug Administration (FDA) exist. In number of cases, the federal court reached a conclusion that the definitions are overlapping and the determination of classification of product only based on definition is very difficult without taking into account the “intended use” concept. It means, if a product is making "drug-like claims (such as prevention or cure of disease)" on labeling, we can slide the classification from food towards drug, while with "nutrition and health claims within the domain of food" can be considered as a food product. For example, honey can appropriately be classified as food, as it is often eaten plain or added as a sweetener to other foods. However, if the label states therapeutic/ disease claims (prevention or treatment of disease) such as “calming an upset stomach”, it falls under the drug definition of section 201(g)(1)(c)(B). On other hand, if the label states “nutrition claims or structure-function claim” such as “honey slows the absorption of trans fats”, it is considered in the food category. Therefore, a food supplement with nutrition and health claims cannot be classified in a drug category, however, those having drug-like claims (such as prevention or cure of disease) will clearly fall in the drug category for regulation. The court also mentioned that no product normally used as a food can be classified as a drug. Classification is the most critical issue as it determines the appropriate regulatory burden in the product as shown in the figure. The regulatory requirement for drug and medical device is significantly more burdensome than for other classes of products.
From the discussion on this part, we should be clear that the ambiguity of food, food supplement and drug cannot be removed just by merging the food and drug control agencies into a single FDA system. In fact, it is more important that specific definition, condition or criteria are set for a clear classification of food, drug and dietary supplement. The concept of “intended use” and the label claims by the manufacture are the important criteria for classification. Food and drug are two different domains of health, having different regulatory requirements. They can be independently run by different organizations, or can also be run by a single FDA like organization.
……………….end of part 2
I will try to continue this series. Keep in touch and follow this blog.
References
M. C. Sanchez, Food Law and Regulation for Non-Lawyers, Food Science Text Series, DOI 10.1007/978-3-319-12472-8_2, © Springer International Publishing Switzerland 2015
In this post, we will try to discuss on the FDA jurisdiction and authority.
The FDA is responsible for protecting and promoting public health through the control and supervision of food safety, tobacco products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), cosmetics, animal foods & feed and veterinary products.
In general, there are 4 categories of products regulated by US FDA: food & dietary supplement, cosmetic, drug and device. The fifth category is those not regulated by FDA. This classification is the heart of all the enforcement decision. Hence, let’s try to discuss and understand this classification better in both technical and legal terms.
The legal definition of food, food additive, dietary supplement and drug are as follows:
------------------------------- you can skip these legal definition, if you are not interested ----------------
"Section 201 (f) “food”: “food” means (1) articles used for food or drink for man or other animals, (2) chewing gum, and (3) articles used for components of any such article"
"Section 201(s) “food additive”: “food additive” means any substance the intended use of which results or may reasonably be expected to result, directly or indirectly, in its becoming a component or otherwise affecting the characteristics of any food (including any substance intended for use in producing, manufacturing, packing, processing, preparing, treating, packaging, transporting, or holding food; and including any source of radiation intended for any such use), if such substance is not generally recognized, among experts qualified by scientific training and experience to evaluate its safety, as having been adequately shown through scientific procedures (or, in the case of a substance used in food prior to January 1, 1958, through either scientific procedures or experience based on common use in food) to be safe under the conditions of its intended use; except that such term does not include—(1) a pesticide chemical residue in or on a raw agricultural commodity or processed food; or(2) a pesticide chemical; or(3) a color additive; or(4) any substance used in accordance with a sanction or approval granted prior to the enactment of this paragraph 4 pursuant to this Act [enacted Sept. 6, 1958], the Poultry Products Inspection Act (21 U.S.C. 451 and the following) or the Meat Inspection Act of March 4, 1907 (34 Stat. 1260), as amended and extended (21 U.S.C. 71 and the following);(5) a new animal drug; or(6) an ingredient described in paragraph (ff) in, or intended for use in, a dietary supplement"
"Section 201 (ff) “Dietary Supplement”: “dietary supplement”—(1) means a product (other than tobacco) intended to supplement the diet that bears or contains one or more of the following dietary ingredients:(A) a vitamin;(B) a mineral;(C) an herb or other botanical;(D) an amino acid;(E) a dietary substance for use by man to supplement the diet by increasing the total dietary intake; or(F) a concentrate, metabolite, constituent, extract, or combination of any ingredient described in clause (A), (B), (C), (D), or (E);(2) means a product that—(A) (i) is intended for ingestion in a form described in section 411(c)(1)(B)(i); or(ii) complies with section 411(c)(1)(B)(ii);(B) is not represented for use as a conventional food or as a sole item of a meal or the diet; and(C) is labeled as a dietary supplement; and(3) does—(A) include an article that is approved as a new drug under section 505 or licensed as a biologic under section 351 of the Public Health Service Act (42 U.S.C. 262) and was, prior to such approval, certification, or license, marketed as a dietary supplement or as a food unless the Secretary has issued a regulation, after notice and comment, finding that the article, when used as or in a dietary supplement under the conditions of use and dosages set forth in the labeling for such dietary supplement, is unlawful under section 402(f); and(B) not include—(i) an article that is approved as a new drug under section 505, certified as an antibiotic under section 507 7, or licensed as a biologic under section 351 of the Public Health Service Act (42 U.S.C. 262), or(ii) an article 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 approval, certification, licensing, or authorization marketed as a dietary supplement or as a food unless the Secretary, in the Secretary’s discretion, has issued a regulation, after notice and comment, finding that the article would be lawful under this ActExcept for purposes of section 201(g), a dietary supplement shall be deemed to be a food within the meaning of this Act"
"Section 201(g) (1)(c) : the term ‘drug’ means … (B) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals…(C) articles (other than food) intended to affect the structure or any function of the body of man or other animals.” Also called the “food exception,” it is the most cited defense to a drug classification of a food-based product claiming some drug-like effect."
-----------------------------------------------------------------------------------------------------------
There were multiple incidences of ambiguity in the classification of product as food, food supplement and drug. There were multiple disputes between FDA and manufacturer in the product classification and for deciding the regulatory requirements. Such issues were challenged in the US court.
This confusion and ambiguity exists even in US where a single Food and Drug Administration (FDA) exist. In number of cases, the federal court reached a conclusion that the definitions are overlapping and the determination of classification of product only based on definition is very difficult without taking into account the “intended use” concept. It means, if a product is making "drug-like claims (such as prevention or cure of disease)" on labeling, we can slide the classification from food towards drug, while with "nutrition and health claims within the domain of food" can be considered as a food product. For example, honey can appropriately be classified as food, as it is often eaten plain or added as a sweetener to other foods. However, if the label states therapeutic/ disease claims (prevention or treatment of disease) such as “calming an upset stomach”, it falls under the drug definition of section 201(g)(1)(c)(B). On other hand, if the label states “nutrition claims or structure-function claim” such as “honey slows the absorption of trans fats”, it is considered in the food category. Therefore, a food supplement with nutrition and health claims cannot be classified in a drug category, however, those having drug-like claims (such as prevention or cure of disease) will clearly fall in the drug category for regulation. The court also mentioned that no product normally used as a food can be classified as a drug. Classification is the most critical issue as it determines the appropriate regulatory burden in the product as shown in the figure. The regulatory requirement for drug and medical device is significantly more burdensome than for other classes of products.
From the discussion on this part, we should be clear that the ambiguity of food, food supplement and drug cannot be removed just by merging the food and drug control agencies into a single FDA system. In fact, it is more important that specific definition, condition or criteria are set for a clear classification of food, drug and dietary supplement. The concept of “intended use” and the label claims by the manufacture are the important criteria for classification. Food and drug are two different domains of health, having different regulatory requirements. They can be independently run by different organizations, or can also be run by a single FDA like organization.
……………….end of part 2
Continue reading the part 3 series below
Related post to read
US Food Law and Regulation Series: Part 1
US Food Law and Regulation Series: Part 2
US Food Law and Regulation Series: Part 1
US Food Law and Regulation Series: Part 2
I will try to continue this series. Keep in touch and follow this blog.
References
M. C. Sanchez, Food Law and Regulation for Non-Lawyers, Food Science Text Series, DOI 10.1007/978-3-319-12472-8_2, © Springer International Publishing Switzerland 2015
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