terms that is specifically authorized by a regulation governing a particular food, or, unless otherwise restricted by regulation, to any use of the term "diet," which clearly shows that the food is offered solely for dietary use(s) other than regulating caloric intake or body weight, e.g., "for low-sodium diets."

(3) Paragraph (e)(1) of this section shall not apply to any use of such terms on a formulated meal replacement, low calorie meal, or other food that is represented to be of special dietary use as a whole meal, pending the issuance of a regulation governing the use of such terms on such foods.

(f) Use of terms such as "sugar free," "sugarless, "no sugar," etc. (1) Consumers may reasonably be expected to regard terms that represent that the food contains no sugars or sweeteners, e.g., "sugar free," "sugarless," "no sugar," as indicating a product which is low in calories or significantly reduced in calories. Consequently, except as provided in paragraph (f)(2) of this section, a food may not be labeled with such terms unless:

(i) It is labeled "low calorie" or "reduced calorie" or bears a comparative claim of special dietary usefulness labeled in compliance with paragraph (c) or (d) of this section, or

(ii) Such term is immediately accompanied, each time it is used, by the statement "Not a reduced calorie food," "Not a low calorie food,"""Not for weight control," "Useful Only In Not Promoting Tooth Decay," or other term indicating that the sole special usefulness of the food is for a specified purpose other than weight control.

(2) Paragraph (f)(1) of this section shall not apply to a factual statement that a food is unsweetened or contains no added sweeteners in the case of a food that contains apparent substantial inherent sugar content, e.g., juices. [43 FR 43259, Sept. 22, 1978; 43 FR 52700, Nov. 14, 1978]

8 105.67 Label statement relating to food for use in the diet of diabetics.

(a) A food that purports to be represented for special dietary use because of usefulness in the diet of diabetics

shall bear nutrition labeling in compliance with § 101.9 of this chapter, unless exempt under that section, and the statement "Diabetics: This product may be useful in your diet on the advice of a physician. This food is not a reduced calorie food." If the food is useful in maintaining or reducing calorie intake or body weight and labeled in conformity with § 105.66, the last sentence may be eliminated.

(b) A food shall not be represented to be useful in the diets of diabetics if such representation is false or misleading.

(c) The term “diabetic," "for diabetics," "diabetes," or the like, shall not be included as part of the name of any food, or otherwise be included on the labeling more prominently than the statement required by paragraph (a) of this section.

(d) The term "dietetic," "diet," or the like, shall not be included in the labeling of a food solely because of its possible usefulness in the diet of diabetics.

(e) A food shall not purport to be or be represented for special dietary use because of usefulness in the diet of diabetics solely by virtue of its being a food useful in reducing or maintaining caloric intake or body weight.

[43 FR 43259, Sept. 22, 1978]

§ 105.69 Foods used to regulate sodium intake.

If a food purports to be or is represented for special dietary use by man by reason of its use as a means of regulating the intake of sodium or salt (sodium chloride), the label shall bear a statement of the number of milligrams of sodium in 100 grams of such food and a statement of the number of milligrams of sodium in a specified serving of such food. The number of milligrams of sodium shall be declared as the nearest multiple of 5 milligrams, as determined by appropriate analysis, except that, if such food contains not more than 10 milligrams of sodium in 100 grams of the food and not more than 10 milligrams of sodium in a specified serving of the food, the label shall bear a statement to that effect.

(a) The definitions contained in section 201 of the Federal Food, Drug, and Cosmetic Act are applicable to such terms when used in this part.

(b) "Commissioner" means the Commissioner of Food and Drugs.

(c) "Act" means the Federal Food, Drug, and Cosmetic Act, as amended.

(d) "Permit" means an emergency permit issued by the Commissioner pursuant to section 404 of the act for such temporary period of time as may be necessary to protect the public health.

(e) "Manufacture, processing, or packing of food in any locality” means activities conducted in a single plant or establishment, a series of plants under a single management, or all plants in an industry or region, by a manufacturer, processor, or packer.

§ 108.5 Determination of the need for a permit.

(a) Whenever the Commissioner determines after investigation that a manufacturer, processor, or packer of a food for which a regulation has been promulgated in Subpart B of this part does not meet the mandatory conditions and requirements established in such regulation, he shall issue to such manufacturer, processor, or packer an order determining that a permit shall be required before the food may be introduced or delivered for introduction into interstate commerce by that person. The order shall specify the mandatory conditions and requirements with which there is a lack of compliance.

(1) The manufacturer, processor, or packer shall have 3 working days after receipt of such order within which to file objections. Such objections may be filed by telegram, telex, or any other mode of written communication addressed to the Food and Drug Administration, Bureau of Foods, 200 C St. SW., Washington, DC 20204. If such objections are filed, the determination is stayed pending a hearing to be held within 5 working days after the filing of objections on the issues involved unless the Commissioner determines that the objections raise no genuine and substantial issue of fact to justify a hearing.

(2) If the Commissioner finds that there is an imminent hazard to health, the order shall contain this finding and the reasons therefor, and shall state that the determination of the need for a permit is effective immediately pending an expedited hearing.

(b) A hearing under this section shall be conducted by the Commissioner or his designee at a location agreed upon by the objector and the Commissioner or, if such agreement cannot be reached, at a location designated by the Commissioner. The manufacturer,

processor, or packer shall have the right to cross-examine the Food and Drug Administration's witnesses and to present witnesses on his own behalf.

(c) Within 5 working days after the hearing, and based on the evidence presented at the hearing, the Commissioner shall determine whether a permit is required and shall so inform the manufacturer, processor, or packer in writing, with the reasons for his deEcision.

1

(d) The Commissioner's determina#tion of the need for a permit constitutes final agency action from which appeal lies to the courts. The Commis#sioner will not stay a determination of the need for a permit pending court appeal except in unusual circumstances, but will participate in expediting any such appeal.

§ 108.6 Revocation of determination of need for permit.

(a) A permit shall be required only during such temporary period as is necessary to protect the public health.

(b) Whenever the Commissioner has reason to believe that a permit holder is in compliance with the mandatory requirements and conditions established in Subpart B of this part and is likely to remain in compliance, he shall, on his own initiative or on the application of the permit holder, revoke both the determination of need for a permit and the permit that had been issued. If denied, the applicant shall, upon request, be afforded a hearing conducted in accordance with § 108.5 (b) and (c) as soon as practicable. Such revocation is without prejudice to the initiation of further permit proceedings with respect to the same manufacturer, processor, or packer should later information again show the need for a permit.

§ 108.7 Issuance or denial of permit.

(a) After a determination and notification by the Commissioner in accordance with the provisions of 108.5 that a manufacturer, processor, or packer requires a permit, such manufacturer, processor, or packer may not thereafter introduce or deliver for introduction into interstate commerce any such food manufactured, processed, or packed by him unless he

holds a permit issued by the Commissioner or obtains advance written approval of the Food and Drug Administration pursuant to § 108.12(a).

(b) Any manufacturer, processor, or packer for whom the Commissioner has made a determination that a permit is necessary may apply to the Commissioner for the issuance of such a permit. The application shall contain such data and information as is necessary to show that all mandatory requirements and conditions for the manufacturer, processing or packing of a food for which regulations are established in Subpart B of this part are met and, in particular, shall show that the deviations specified in the Commissioner's determination of the need for a permit have been corrected or suitable interim measures established. Within 10 working days after receipt of such application, (except that the Commissioner may extend such time an additional 10 working days where necessary), the Commissioner shall issue a permit, deny the permit, or offer the applicant a hearing conducted in accordance with § 108.5 (b) and (c) as to whether the permit should be issued. The Commissioner shall issue such a permit to which shall be attached, in addition to the mandatory requirements and conditions of Subpart B of this part, any additional requirements or conditions which may be necessary to protect the public health if he finds that all mandatory requirements and conditions of Subpart B of this part are met or suitable interim measures are established.

(c) Denial of a permit constitutes final agency action from which appeal lies to the courts. The Commissioner will not stay such denial pending court appeal except in unusual circumstances, but will participate in expediting any such appeal.

8 108.10 Suspension and reinstatement of permit.

(a) Whenever the Commissioner finds that a permit holder is not in compliance with the mandatory requirements and conditions established by the permit, he shall immediately suspend the permit and so inform the

permit holder, with the reasons for the suspension.

(b) Upon application for reinstatement of a permit, the Commissioner shall, within 10 working days, reinstate the permit if he finds that the person is in compliance with the mandatory requirements and conditions established by the permit or deny the application.

(c) Any person whose permit has been suspended or whose application for reinstatement has been denied may request a hearing. The hearing shall be conducted by the Commissioner or his designee within 5 working days of receipt of the request at a location agreed upon by the objector and the Commissioner or, if an agreement cannot be reached, at a location designated by the Commissioner. permit holder shall have the right to present witnesses on his own behalf and to cross-examine the Food and Drug Administration's witnesses.

The

(d) Within 5 working days after the hearing, and based on the evidence presented at the hearing, the Commissioner shall determine whether the permit shall be reinstated and shall so inform the permit holder, with the reasons for his decision.

(e) Denial of an application for reinstatement of a permit constitutes final agency action from which appeal lies to the courts. The Commisioner will not stay such denial pending court unusual appeal except in circumstances, but will participate in expediting any such appeal.

§ 108.12 Manufacturing,

processing, or packing without a permit, or in violation of a permit.

(a) A manufacturer, processor, or packer may continue at his own risk to manufacture, process, or pack without a permit a food for which the Commissioner has determined that a permit is required. All food so manufactured, processed, or packed during such period without a permit shall be retained by the manufacturer, processor, or packer and may not be introduced or delivered for introduction into interstate commerce without the advance written approval of the Food and Drug Administration. Such approval may be granted only upon an

adequate showing that such food is free from microorganisms of public health significance. The manufactur er, processor, or packer may provide to the Commissioner, for his considera tion in making any such determina tion, an evaluation of the potential public health significance of such food by a competent authority in accordance with procedures recognized as being adequate to detect any potential hazard to public health. Within 20 working days after receipt of a written request for such written approval the Food and Drug Administration shall either issue such written approval or deny the request. If the request is denied, the applicant shall, upon request, be afforded a prompt hearing conducted in accordance with § 108.5 (b) and (c).

(b) Except as provided in paragraph (a) of this section, no manufacturer, processor, or packer may introduce or deliver for introduction into interstate commerce without a permit or in violation of a permit a food for which the Commissioner has determined that a permit is required. Where a manufac turer, processor, or packer utilizes a consolidation warehouse or other storage facility under his control, interstate shipment of any such food from the point of production to that warehouse or storage facility shall not violate this paragraph, provided that no further introduction or delivery for introduction into interstate commerce is made from that consolidated warehouse or storage facility except as provided in paragraph (a) of this section.

§ 108.19 Establishment of requirements for exemption from section 404 of the act.

(a) Whenever the Commissioner finds after investigation that the distribution in interstate commerce of any class of food may, by reason of contamination with microorganisms during the manufacture, processing, or packing thereof in any locality, be injurious to health, and that such injurious nature cannot be adequately determined after such articles have entered interstate commerce, he shall promulgate regulations in Subpart B of this part establishing requirements

and conditions governing the manufacture, processing, or packing of the food necessary to protect the public health. Such regulations may be proposed by the Commissioner on his own initiative or in response to a petition from any interested person pursuant to Part 10 of this chapter.

(b) A manufacturer, processor, or packer of a food for which a regulation has been promulgated in Subpart B of this part shall be exempt from the requirement for a permit only if he meets all of the mandatory requirements and conditions established in that regulation.

[42 FR 14334, Mar. 15, 1977, as amended at 42 FR 15673, Mar. 22, 1977]

§ 108.25 Acidified foods.

(a) Inadequate or improper manufacture, processing, or packing of acidified foods may result in the distribution in interstate commerce of processed foods that may be injurious to health. The harmful nature of such foods cannot be adequately determined after these foods have entered into interstate commerce. The Commissioner of Food and Drugs therefore finds that, to protect the public health, it may be necessary to require any commericial processor, in any establishment engaged in the manufacture, processing, or packing of acidified foods, to obtain and hold a temporary emergency permit provided for under section 404 of the Federal Food, Drug, and Cosmetic Act. Such permit may be required whenever the Commissioner finds, after investigation, that the commercial processor has failed to fulfill all the requirements of this section, including registration and filing of process information, and the mandatory portions of §§ 114.10, 114.80(a) (1) and (2), and (b), 114.83, 114.89, and 114.100 (b), (c), and (d) of this chapter as they relate to acidified foods. These requirements are intended to ensure safe manufacturing, processing, and packing processes and to permit the Food and Drug

a

Administration to verify that these processes are being followed. Failure to meet these requirements shall constitute a prima facie basis for the immediate application of the emergency permit control provisions of section 404 of the act to that establishment, under the procedures established in Subpart A of this part.

(b) The definitions in § 114.3 of this chapter are applicable when those terms are used in this section.

(c) (1) Registration. A commercial processor, when first engaging in the manufacture, processing, or packing of acidified foods in any State, as defined in section 201(a)(1) of the act, shall, not later than 10 days after first so engaging, register and file with the Food and Drug Administration on Form FD-2541 (food canning establishment registration) information including, but not limited to, the name of the establishment, principal place of business, the location of each establishment in which that processing is carried on, the processing method in terms of acidity and pH control, and a list of foods so processed in each establishment. These forms are available from the Food and Drug Administration, Bureau of Foods, Industry Guidance Branch (HFF-342), 200 C St. SW., Washington, DC 20204, or at any Food and Drug Administration district office. The completed form shall be submitted to the Food and Drug Administration, Bureau of Foods, Industry Guidance Branch (HFF-342), 200 C St. SW., Washington, DC 20204. Commercial processors presently so engaged shall register within 120 days after the effective date of this regulation. Foreign processors shall register within 120 days after the effective date of this regulation or before any offering of foods for import into the United States, whichever is later. Commercial processors duly registered under this section shall notify the Food and Drug Administration not later than 90 days after the commercial processor ceases or discontinues the manufacture, processing, or packing of the foods in any establishment, except that this notification shall not be required for temporary cessations due to the seasonal character of an establishment's production or by tempo