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COMPLIANCE POLICY GUIDE (CPG)

CPG Sec 555.100 Alcohol; Use of Synthetic Alcohol in Foods February 1989

Final
Issued by:
Guidance Issuing Office
Center for Food Safety and Applied Nutrition
Office of Regulatory Affairs

BACKGROUND:

Increasing quantities of alcohol (ethyl alcohol) have been made synthetically from natural gas and petroleum derivatives.

Questions about the suitability of synthetic alcohol for use in manufacturing vinegar arose as early as l948. By Administration Information Letter No. 90, dated January 28, l949, the districts were advised that we seriously doubted that a product made from synthetic alcohol could be appropriately regarded as a type of vinegar.

Early in l957 the Director, Alcohol and Tobacco Tax division, Internal Revenue Service asked for comment on the suitability of synthetic alcohol for use in foods and drugs. Our comments in a letter dated February 5, l957, signed by Mr. M. R. Stephens, who was then Director, Bureau of Enforcement, included the following paragraphs:

"Ethyl alcohol is recognized in the U.S. Pharmacopeia, one of the official drug compendiums under the Federal Food, Drug, and Cosmetic Act; consequently, ethyl alcohol intended for drug use must comply with the standards and tests laid down in the Pharmacopeia. Since the Pharmacopeia does not place any restrictions as to the method of manufacturing ethyl alcohol, synthetic alcohol which complies with the standards and tests set forth in the official monograph may legally be distributed for drug use.

"We consider that the situation with respect to foods is different. We believe that consumers generally expect the alcohol in food products to have been produced from fermented food substances, such as grains, fruit, etc., and that they do not expect their foods to contain 'alcohol' produced from petroleum gas.

"For this reason, we have advised inquirers that we do not regard this synthetic alcohol as a suitable food ingredient. This position, however, has not been the subject of any court review.

In reply to many letters from industry and from members of Congress, we consistently advised that we considered synthetic alcohol unsuitable for food use.

Questions have been raised as to whether we can or should continue to consider synthetic alcohol unsuitable for food use. In order to secure more information, we wrote to the Alcohol, Tobacco and Firearms Division, Internal Revenue Service. Their reply included the following paragraphs:

"Presently, we authorize the manufacture of vinegar from ethyl alcohol synthesized from natural gas or petroleum derivatives. It is our opinion that most of the distilled spirits used in the production of vinegar are derived from natural gas and petroleum. When such alcohol is used in the production of vinegar, we would consider any reference to 'grain alcohol' or 'neutral grain spirits' would be misleading for the alcohol and also the name 'grain vinegar' would be misleading, except for connoting strength, e.g., 40-grains.

"When alcohol is used in the production of beverage products, our regulations require that the source of the alcohol be shown on the label except for cordials and liqueurs. Incidentally, I might add that most of the alcohol used in the production of medicinal preparations and flavors is synthetic."

Practically and scientifically, pure ethyl alcohol synthesized from natural gas or petroleum products does not differ from that obtained by fermentation with subsequent distillation. Furthermore, foods in which one is used cannot be distinguished objectively from those in which the other is used.

POLICY:

Synthetic ethyl alcohol may be used as a food ingredient or in the manufacturing of vinegar or other chemicals for food use, within limitations imposed by the Federal Food, Drug, and Cosmetic Act, the Alcohol Administration Act, and regulations promulgated under these acts.

Any labeling reference to synthetic alcohol as "grain alcohol" or "neutral grain spirits" is considered false and misleading.

Issued: 7/25/69
Reissued: 12/3/73, 10/1/80
Revised: 2/1/89


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Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)

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