Food additive petition

FDA Quality Standards. Although standards for many dmgs and biologicals are included in the USP—NF, and for many food additives in the FCC, the FDA also estabhshes some specifications of its own. In the dmg field, specifications and testing methods for antibiotics and biologicals are set by the FDA. Also, specifications and testing methods are prescribed for colorants. Many food-additive petitions are granted with the requirement that certain specifications are met. 

Countries that use a positive Hst, eg, Japan, Switzerland, the former Soviet Union, and the United States, Hst ak substances akowable in flavor and foods any material not Hsted is not akowable. Any material included on a positive Hst is considered safe for its intended use. This system works wek only if there is a specific procedure to akow for the addition of new materials. In the United States there is the Food Additive Petition and the GRAS route. No new material can be used in flavor or foods unless it undergoes one of these two procedures. This assures that any new technology can be added and used after it is reviewed for safety. 

Sucrose polyesters, which are made by esterilying sucrose with long-chain fatty acids, have the physical properties of fat, but are resistant to digestive enzymes (40). Olestra, a sucrose polyester developed by Procter Gamble, was submitted for regulatory approval in May 1987. In order to faciUtate the approval process, Procter Gamble has since narrowed the scope of its food additive petition to include olestra s use only in savory and extmded snacks. 

Abbott Laboratories, which has conducted additional toxicity and carcinogenicity studies with cyclamate, a 10 1 mixture of cyclamate—saccharin, and cyclohexylamine, claimed to be unable to confirm the 1969 findings. Abbott then filed a food additive petition for cyclamate in 1973, which was denied by the FDA in 1980. In 1982, the Calorie Control Council and Abbott Laboratories filed a second food additive petition containing the results of additional safety studies (73). That petition was stiU pending as of 1996. Cyclamate is, however, allowed for use in any or all three categories, ie, food, beverage, and tabletop, in about 50 countries. Sweet n Low, known in the United States as a saccharin-based table-top sweetener, contains exclusively cyclamate in Canada. 

Stevioside and rebaudioside A are diterpene glycosides. The sweetness is tainted with a bitter and undesirable aftertaste. The time—intensity profile is characteristic of naturally occurring sweeteners slow onset but lingering. The aglycone moiety, steviol [471 -80-7] (10), which is the principal metaboHte, has been reported to be mutagenic (79). Wide use of stevia ia Japan for over 20 years did not produce any known deleterious side effects. However, because no food additive petition has been presented to the FDA, stevioside and related materials caimot be used ia the United States. An import alert against stevia was issued by the FDA ia 1991. In 1995, however, the FDA revised this import alert to allow the importation and use of stevia as a diet supplement (80), but not as a sweetener or an ingredient for foods. Several comprehensive reviews of stevia are available (81,82). 

Sucralose. Sucralose [56038-13-2] is a trichlorodisaccharide sweetener developed by the British sugar company Tate Lyle during the 1970s (87—89). It was Hcensed to McNeil Specialty Products Company (a Johnson Johnson subsidiary) in the United States. A food additive petition was filed with the FDA in 1987 (90). As of December, 1996, the petition was still pending. Sucralose was approved for use as a sweetener by Canada in 1991, by Austraha, Mexico, and Russia in 1993, by Romania in 1994, and by New Zealand in 1996. 

Section 409(b)(2) of the Act describes the statutory requirements for food additive petitions. Briefly, these encompass five general areas of information ... 

CFR 171.1(c) describes in greater detail the data requirements for food additive petitions, including the five basic areas of information and scientific data noted above, as well as other administrative information and environmental assessment requirements. This document addresses chemistry-related issues only. As described in 21 CFR 171.1(h), certain data and information contained in food additive petitions are available for public disclosure, while other data are not. Questions in this regard should be directed to the Office of Premarket Approval. 

Recommendations for chemistry data for indirect food additive petitions, June, 1995... 

These recommendations are intended to amplify and explain the statutory chemistry requirements for indirect food additive petitions. The science and technology of food-packaging and food-contact articles as well as the scientific basis for evaluating exposure to indirect food additives are continually evolving. Therefore, for the most current information go directly to http // vm.cfsan.fda. gov/ drns/opa-cg5. html... 

Alitame. A new group of aspartyl-dipeptide sweeteners became known to the public in 1983 (95). Alitame [80863-62-3 ], l- as p a rtyl- d - alanine A -(2,2,4,4-tetramethylthietan-3-yl)armde (16), was selected for commercial development. In 1986 Pfizer filed a food additive petition with the FDA. As of December, 1996, it was still pending. Alitame was approved for use as a sweetener by Australia in 1993, by China, Mexico, and New Zealand in 1994, by Indonesia in 1995, and by Colombia in 1996. 

The evaluation of the safety of a new excipient as a food additive could be accomplished by the submission of a food additive petition to the United Nations expert panel operating under the auspices of the FAO and the World Health Organization known as the JECFA. A JECFA review could serve as a separate independent safety review to support the new excipient for potential use in drug products. Alternatively, the safety of a new excipient could be evaluated through the food additive petition processes, as currently in practice both in the United States and the EU, assuming that the new excipient can be demonstrated to have a technological function as a food additive. 

The use of food additive petitions and GRAS procedures to evaluate the safety of a proposed new excipient would apply to the oral route of administration for the excipient and would not generally apply to other routes of administration. Some routes of administration (e.g., inhalation) result in unique toxicological requirements, and data would have to be developed for the specific route of administration. While toxicological data from systemic studies are important for excipients used for nonoral applications, separate data would be needed for the specific route of administration. Nevertheless, the amount of safety data, specifications, and intake information required for a food additive review is extensive, and therefore could provide a firm basis of safety for a new excipient. 

Therefore, a food additive is a substance that is intentionally added to foods and does not include substances that are GRAS. A food additive petition must be filed in order to obtain an authorization from FDA specifying the conditions under which a food additive may be safely used. The FDA conducts a very comprehensive review of the safety of a food additive when a petition is submitted. 

The Act describes the information that a food additive petition must contain for the chemistry, safety, and functionality of the additive. Food additive petitions are submitted to the FDA under the provisions of section 409(b) of the Act and must include the following information ... 

The FDA must act upon a food additive petition within 180 days. It can take many years to obtain an approval for a new food additive due to the lengthy review process and the interaction with the petitioner. When approved, FDA issues a specific regulation for the food additive, which specifies the amount of the food additive that may safely be used and the conditions of use for the additive. The conditions of use may be related to levels of use, types of foods, and application of use. 

Information and data from toxicological tests are essential requirements of the food additive petition. The Redbook 2000 Toxicology Principles for the Safety Assessment of Food Ingredients (16) provides guidance to industry concerning the appropriate tests for the determination of safety. The Redbook discusses concern levels as a method to determine recommended toxicology tests for food and color additives. A level of concern can be assigned based on the potential health risk of the food additive. 

Recommendations for chemistry data for indirect food additive petitions. Center for Food Safety and Applied Nutrition, FDA, Washington, D.C. September 1988 v. 1.1... 

Table 2.2 Regulatory options relevant to food contact materials with regard to the food additive petition (petition), food contact notification (FCN) and threshold of regulation (TOR) exemption processes...

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