(ii) If none of the natural flavor used in the food is derived from the product whose flavor is simulated, the food in which the flavor is used shall be labeled either with the flavor of the product from which the flavor is derived or as "artificially flavored.". It’s no secret to those in the food manufacturing industry that the FDA is pretty particular—especially when it comes to nutrition facts labels. (2) An incidental additive in a food, originating in a spice or flavor used in the manufacture of the food, need not be declared in the statement of ingredients if it meets the requirements of § 501.100(a)(3). For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR). Continue reading to learn about what is required on your food product label. Your product must comply with the following labeling requirements under FDA regulations: the intended use statement (21 CFR 809.10(a)(2), (b)(2)); adequate directions for use (21 U.S.C. (b) A food which is subject to the requirements of section 403(k) of the act shall bear labeling, even though such food is not in package form. The intent of this handout is to provide the basic requirements and guidance for food labeling. Labeling regulations pertaining to medical devices are found in the following Parts of Title 21 of the Code of Federal Regulations (CFR). The term "piece" is used as a generic description of a discrete unit. In cases where the flavor contains a solely artificial flavor(s), the flavor shall be so labeled, e.g., "artificial strawberry flavor". No representation may be made, either directly or implied, that a food flavored with pyroligneous acid or other artificial smoke flavor has been smoked or has a true smoked flavor, or that a seasoning sauce or similar product containing pyroligneous acid or other artificial smoke flavor and used to season or flavor other foods will result in a smoked product or one having a true smoked flavor. While FDA food labeling regulations can seem overwhelming and confusing, using online nutrition analysis software can save you a lot of time you’d otherwise spend scrolling through lengthy government documents. Bottling and packaging requirements for spice blends - posted in Food Safety Talk: Hello, I have been an avid home cook for some 15 years. The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled "Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers." For more information, refer to 21 CFR § 101.72 101.83, the . 303.757.1333. (2) The term spice means any aromatic vegetable substance in the whole, broken, or ground form, except for those substances which have been traditionally regarded as foods, such as onions, garlic and celery; whose significant function in food is seasoning rather than nutritional; that is true to name; and from which no portion of any volatile oil or other flavoring principle has been removed. The FDA regulates most packaged foods sold in the United States and has specific requirements for what elements a package must include such as a Nutrition Facts panel and manufacturer information. Natural flavors include the natural essence or extractives obtained from plants listed in §§ 182.10, 182.20, 182.40, and 182.50 and part 184 of this chapter, and the substances listed in § 172.510 of this chapter. Home; Food; Drugs; Medical Devices; Radiation-Emitting Products; Vaccines, Blood & Biologics; Animal & Veterinary; Cosmetics; Tobacco Products . General Labeling Provisions. The examination conducted by the Secretary's representative shall be limited to inspection and review of inventories and ingredient records for those certifications which are to be verified. The defenses provided under section 303(c)(2) of the act shall be applicable to the certifications provided for in this section. All such certifications shall be retained by the certifying party throughout the period in which the flavor is supplied and for a minimum of three years thereafter, and shall be subject to the following conditions: (i) The certifying party shall make such certifications available upon request at all reasonable hours to any duly authorized office or employee of the Food and Drug Administration or any other employee acting on behalf of the Secretary of Health and Human Services.