2 The source of protein shall be at least nutritionally equivalent to casein.

3 Retinol equivalents.

4 Required to be included in this amount only in formulas which are not milk-based.

5 Calcium to phosphorus ratio must be no less than 1.1 nor more than 2.0.

NEW DIETARY INGREDIENTS

SEC. 413. [21 U.S.C. 350b] (a) IN GENERAL.-A dietary supplement which contains a new dietary ingredient shall be deemed adulterated under section 402(f) unless it meets one of the following requirements:

(1) The dietary supplement contains only dietary ingredients which have been present in the food supply as an article used for food in a form in which the food has not been chemically altered.

(2) There is a history of use or other evidence of safety establishing that the dietary ingredient when used under the conditions recommended or suggested in the labeling of the dietary supplement will reasonably be expected to be safe and, at least 75 days before being introduced or delivered for introduction into interstate commerce, the manufacturer or distributor of the dietary ingredient or dietary supplement provides the Secretary with information, including any citation to

published articles, which is the basis on which the manute turer or distributor has concluded that a dietary supplement containing such dietary ingredient will reasonably be expected to be safe.

The Secretary shall keep confidential any information provided under paragraph (2) for 90 days following its receipt After the expiration of such 90 days, the Secretary shall place such informa tion on public display, except matters in the information which are trade secrets or otherwise confidential, commercial information

(b) PETITION.-Any person may file with the Secretary a pott tion proposing the issuance of an order prescribing the conditions under which a new dietary ingredient under its intended conditiona of use will reasonably be expected to be safe. The Secretary shall make a decision on such petition within 180 days of the date the petition is filed with the Secretary. For purposes of chapter 7 of title 5, United States Code, the decision of the Secretary shall be considered final agency action.

(c) DEFINITION.-For purposes of this section, the term "now dietary ingredient" means a dietary ingredient that was not m keted in the United States before October 15, 1994 and does not include any dietary ingredient which was marketed in the United States before October 15, 1994.

SEC. 414. [21 U.S.C. 350c] MAINTENANCE AND INSPECTION

RECORDS.

OF

(a) RECORDS INSPECTION. If the Secretary has a reemble belief that an article of food is adulterated and presents a threat of serious adverse health consequences or death to humans or am mals, each person (excluding farms and restaurantaj who manufar tures, processes, packs, distributes, receives, holds, or import such article shall, at the request of an officer or employed duly des ignated by the Secretary, permit such officer or employed, upm presentation of appropriate credentials and a wr94, il y seg person, at reasonable times and with reasonate hunde wo4 in * reasonable manner, to have auras y and oopy wil rende pobry to such article ta we werfen 'n weeld, MNAR BAAN) v GMAT mining whetter te won a wonderden ALO YIKIAME * Manan, kun rious adrene 16th, 17 M * GEA, ÎN bylab by bhk The reprezes ze te gebryst way ". recuras rezZqV TE “Arshat, was a big, by von Kr tion recent wong * **ft, & BAT AP, BB, My chodily hy a seat of sex porn my ba electroce funza vizzy MAN

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The Secretary shall take into account the size of a business in promulgating regulations under this section.

(c) PROTECTION OF SENSITIVE INFORMATION.-The Secretary shall take appropriate measures to ensure that there are in effect effective procedures to prevent the unauthorized disclosure of any trade secret or confidential information that is obtained by the Secretary pursuant to this section.

(d) LIMITATIONS.-This section shall not be construed

(1) to limit the authority of the Secretary to inspect records or to require establishment and maintenance of records under any other provision of this Act;

(2) to authorize the Secretary to impose any requirements with respect to a food to the extent that it is within the exclusive jurisdiction of the Secretary of Agriculture pursuant to the Federal Meat Inspection Act (21 U.S.C. 601 et seq.), the Poultry Products Inspection Act (21 U.S.C. 451 et seq.), or the Egg Products Inspection Act (21 U.S.C. 1031 et seq.);

(3) to have any legal effect on section 552 of title 5, United States Code, or section 1905 of title 18, United States Code; or

(4) to extend to recipes for food, financial data, pricing data, personnel data, research data, or sales data (other than shipment data regarding sales).

SEC. 415. [21 U.S.C. 350d] REGISTRATION OF FOOD FACILITIES. (a) REGISTRATION.

(1) IN GENERAL.-The Secretary shall by regulation require that any facility engaged in manufacturing, processing, packing, or holding food for consumption in the United States be registered with the Secretary. To be registered

(A) for a domestic facility, the owner, operator, or agent in charge of the facility shall submit a registration to the Secretary; and

(B) for a foreign facility, the owner, operator, or agent in charge of the facility shall submit a registration to the Secretary and shall include with the registration the name of the United States agent for the facility.

(2) REGISTRATION.-An entity (referred to in this section as the "registrant") shall submit a registration under paragraph (1) to the Secretary containing information necessary to notify the Secretary of the name and address of each facility at which, and all trade names under which, the registrant conducts business and, when determined necessary by the Secretary through guidance, the general food category (as identified under section 170.3 of title 21, Code of Federal Regulations) of any food manufactured, processed, packed, or held at such facility. The registrant shall notify the Secretary in a timely manner of changes to such information.

(3) PROCEDURE.-Upon receipt of a completed registration described in paragraph (1), the Secretary shall notify the registrant of the receipt of such registration and assign a registration number to each registered facility.

(4) LIST.-The Secretary shall compile and maintain an up-to-date list of facilities that are registered under this section. Such list and any registration documents submitted pur

suant to this subsection shall not be subject to disclosure under section 552 of title 5, United States Code. Information derived from such list or registration documents shall not be subject to disclosure under section 552 of title 5, United States Code, to the extent that it discloses the identity or location of a specific registered person.

(b) FACILITY.-For purposes of this section:

(1) The term "facility" includes any factory, warehouse, or establishment (including a factory, warehouse, or establishment of an importer) that manufactures, processes, packs, or holds food. Such term does not include farms; restaurants; other retail food establishments; nonprofit food establishments in which food is prepared for or served directly to the consumer; or fishing vessels (except such vessels engaged in processing as defined in section 123.3(k) of title 21, Code of Federal Regulations).

(2) The term "domestic facility" means a facility located in any of the States or Territories.

(3)(A) The term "foreign facility" means a facility that manufacturers, processes, packs, or holds food, but only if food from such facility is exported to the United States without further processing or packaging outside the United States.

(B) A food may not be considered to have undergone further processing or packaging for purposes of subparagraph (A) solely on the basis that labeling was added or that any similar activity of a de minimis nature was carried out with respect to the food.

(c) RULE OF CONSTRUCTION.-Nothing in this section shall be construed to authorize the Secretary to require an application, review, or licensing process.

CHAPTER V-DRUGS AND DEVICES

SUBCHAPTER A-DRUGS AND DEVICES

ADULTERATED DRUGS AND DEVICES

SEC. 501. [21 U.S.C. 351] A drug or device shall be deemed to be adulterated-1

(a)(1) If it consists in whole or in part of any filthy, putrid, or decomposed substance; or (2)(A) if it has been prepared, packed, or held under insanitary conditions whereby it may have been contaminated with filth, or whereby it may have been rendered injurious to health; or (B) if it is a drug and the methods used in, or the facilities or controls used for, its manufacture, processing, packing, or holding do not conform to or are not operated or administered in conformity with current good manufacturing practice to assure that such drug meets the requirements of this Act as to safety and has the identity and strength, and meets the quality and purity characteristics, which it purports or is represented to possess; or (C) if it is a compounded positron emission tomography drug and the methods used in, or the facilities and controls used for, its compounding, processing, packing, or holding do not conform to or are not operated or administered in conformity with the positron emission tomography compounding standards and the official monographs of the United States Pharmacopoeia to assure that such drug meets the requirements of this Act as to safety and has the identity and strength, and meets the quality and purity characteristics, that it purports or is represented to possess; or (3) if its container is composed, in whole or in part, of any poisonous or deleterious substance which may render the contents injurious to health; or (4) if (A) it bears or contains, for purposes of coloring only, a color additive which is unsafe within the meaning of section 721(a), or (B) it is a color additive the intended use of which in or on drugs or devices is for purposes of coloring only and is unsafe within the meaning of section 721(a); or (5) if it is a new animal drug which is unsafe within the meaning of section 512; or (6) if it is an animal feed bearing or containing a new animal drug, and such animal feed is unsafe within the meaning of section 512.

(b) If it purports to be or is represented as a drug the name of which is recognized in an official compendium, and its strength differs from, or its quality or purity falls below, the standards set forth in such compendium. Such determination as to strength, quality, or purity shall be made in accordance with the tests or methods of assay set forth in such compendium, except that whenever tests or methods of assay have not been prescribed in such compendium, or such tests or methods of assay as are prescribed

etc.

1 See footnote for section 403(h)(3) regarding the stylistic use of a list consisting of “(a)”, “(b)”,