5759. Action to enjoin and restrain interstate shipments of Mrs. Price's Com¬ pound, Mrs. Price's Specially Prepared Package of Boric Acid, and Price's No Ice. U. S. v. Metta T* Price (Price Compound Co.). Permanent injunc- tion granted. (Inj. No. 57.) On June 21, 1943, the United States attorney for the District of Minnesota filed a complaint for the purpose of enjoining Meta T. Price, doing business as the Price Compound Co., Minneapolis, Minn., from the sale and distribution of the above-named products offered for use in home canning and food preservation. The principal allegations of the complaint were substantially sustained by the findings of fact and conclusions of law set forth hereinafter. < On June 28, 1943, based on the written-stipulation of the defendant, the court entered the following findings of fact and conclusions of law: FINDINGS OF FACT "Plaintiff brings this action for the purpose of enjoining the defendant from violating the provisions of Section 301 (a) of the Federal Food, Drug and Cosmetic Act (Act June 25, 1938, c. 675, 50 Stat. 1040; Title 21 U. S. C, Section 301 et seq.) hereinafter called 'The Act.' II "The defendant, Metta T. Price, resides in the City of Minneapolis, County of Hennepin, State of Minnesota, and within the jurisdiction of this Court, and at all times since about 1937 has been the sole owner and operator of a place of business in said City of Minneapolis, aforesaid, where she is engaged and has been engaged under the name and style of Price Compound Company in the sale and distribution of chemieal preservatives offered for use in home canning and food preservation. Ill "Since about the year 1937, defendant has been engaged in the sale and distribu- tion in the channels of interstate commerce of products hereinafter mentioned, upon the labels of Which appear, among other things, these inscriptions: 'Mrs. Price's Specially Prepared Package of Boric Acid', 'Mrs. Price's Compound', and 'Price's No Ice'. Said products, have been shipped by defendant from her place of business in the said City of Minneapolis, aforesaid, to, into, and through states other than the State of Minnesota. IV "The said product, labeled in part, 'Mrs. Price's Specially Prepared Package of Boric Acid', is a white powder consisting of 100 percent boric acid. Said products, labeled in part, 'Mrs. Price's Compound' and 'Price's No Ice' are white powders each consisting of approximately 95 percent boric acid and approximately 5 percent sodium chloride (salt). V "The said products, labeled in part, 'Mrs. Price's Specially Prepared Package of Boric Acid' and 'Mrs. Price's Compound' are offered for sale and recommended for use in the home canning of vegetables, fruits, pickles and preserves. Said product, labeled in part, 'Price's No Ice', is offered for sale and recommended for use in the preservation of freshly killed fish and game and to prevent milk and cream from souring. VI "Accompanying said products labeled in part, 'Mrs. Price's Compound' and 'Mrs. Price's Specially Prepared Package of Boric Acid' are booklets entitled, 'Mrs. Price's Complete Directions for Canning Vegetables and Fruits, Pickling, etc.', published in several editions. Such booklets contain recommendations and instructions as to the use of said products as preservatives in the home canning of vegetables, fruits, pickles and preserves. Also included upon the labels of the packages containing said products, and the product labeled in part, 'Price's No Ice,' is printed matter prescribing and recommending the manner and means of using said products as home preservatives and in the preservation of freshly killed game and fish and to prevent milk and cream from souring. VI "Commencing on or about September 23, 1942, and again about the middle of May, 1943, said product, labeled in part, 'Mrs. Price's Compound', and said product, labeled in part, 'Mrs. Price's Specially Prepared Package of Boric Acid', have been and now are the subject of numerous libel or seizure actions commenced \>y the United States of America in various federal judicial districts throughout the United States seeking the condemnation of the quantities seized as mis- branded under the Act. In at least two instances, decrees in favor of the United States of America, as libelant, have been entered condemning, forfeiting and ordering the destruction of such quantities of the said products as were involved in those proceedings. About ten libel proceedings against various shipments of said products are presently pending. "The printed matter distributed with the products labeled in part, 'Mrs. Price's Specially Prepared Package of Boric Acid' and 'Mrs. Price's Compound', and the printed matter appearing upon the packages containing said products represent and suggest that the said 'Mrs. Price's Specially Prepared Package of Boric Acid' and 'Mrs. Price's Compound', when used as directed, in the canning of vegetables, fruits, pickles and preserves, is safe and appropriate for such uses and will effect proper sterilization, conservation and preservation of home canned foods? * * * The printed matter appearing upon the packages con- taining the product labeled in part, 'Price's No Ice', represent and suggest that the use therof will prevent milk and cream from souring and will keep and preserve freshly killed game and fish. * * * Y "The use of the products labeled in part, 'Mrs. Price's Compound' and 'Mrs. Price's Specially Prepared Package of Boric Acid', by virtue of being composed largely of boric acid is potentially dangerous to the health of the consumer. The directions recommended in the printed matter * * * do not adequately insure the proper sterilization of the utensils used in the canning procedure, nor do they adequately insure the destruction of heat resistant spore forming bacteria capable of producing spoilage and toxins dangerous to health. "The use of the product labeled in part, 'Price's No Ice' in accordance with the directions set forth in the printed matter * •* * will not be effective to prevent milk and cream from souring and in preserving freshly killed game and fish. Such directions do hot assure adequate removal of the boric acid used in the preservation process, and thus do not protect a consumer against the hazards to health implicit in the consumption of boric acid. XI "The use of boric acid as a preservative either for canned foods or fresh foods is specifically recognized as dangerous to health in that the consumption of as little as one-half gram of boric acid per day over long periods of time is dele- terious to health in that serious chronic poisoning will result. Use of the products labeled in part, 'Mrs. Price's Compound' and 'Mrs. Price's Specially Prepared Package of Boric Acid', in accordance with the directions contained in the printed matter * * * can result in the consumption by an average family of five, receiving five servings to a quart of home canned food, of as much as 1.24 grams of boric acid daily for each quart used. XII ''Specifically, the Court finds that the use of the products labeled in part, 'Mrs. Price's Compound' and 'Mrs. Price's Specially Prepared Package of Boric Acid'; in accordance with the directions set forth in the printed matter * * * does not protect against the bacteria known as Clostridium botulinum, which is the organism that produces the toxin which has caused fatalities following a consumption of home canned food." CONCLUSIONS OF LAW "The Court is authorized by Section 302 (a) of the Federal Food, Drug and Cosmetic Act to restrain the introduction or delivery for introduction, or the causing of introduction or delivery for introtluction into interstate commerce of any food or drug which is misbranded. n "Cause has been shown justifying the issuance of a Permanent Injunction. Ill "The said product labeled in part, 'Mrs. Price's Specially Prepared Package of Boric Acid' is both a food within the meaning of Section 201 (f) (3) and a drug within the meaning of Section 201 (g) (1) of the Act. The said products labeled in part, 'Mrs. Price's Compound' and Trice's No Ice', are foods within the meaning of Section 201 (f) (3) of the Act. IV " ' . ' "The written, printed and graphic matter accompanying and appearing upon the packages containing the products labeled in part, 'Mrs. Price's Compound', 'Mrs. Price's Specially Prepared Package of Boric Acid' and 'Price's No Ice', constitute labeling within the meaning of Section 201 (m) of the Act. within the meaning of Section 403 (a) of the Act in that the statements in Exhibits A, B, C, and D are misleading since such Exhibits, when read in their respective entirety, represent and" suggest, and engender the impression in the minds of readers, that said 'Mrs. Price's Compound', when used as directed in its labeling in the canning of vegetables, fruits, pickles and preserves, is safe and. appropriate for such uses, and will effect proper sterilization, conservation and preservation of. home canned foods; whereas, use of said 'Mrs. Price's Compound', as directed, is potentially dangerous to the health of the consumer, and will not insure proper sterilization, conservation and preservation of home canned foods. ~ ' VI. "The article of food and drug, labeled in part, 'Mrs. Price's Specially Prepared Package of Boric Acid' is misbranded within the meaning of Sections 403 (a) and 502 (a) of the Act in that the statements in Exhibits A and B are misleading since such Exhibits, when read in their respective entirety, represent and suggest, and engender the impression in the minds of readers, that said 'Mrs. Price's Specially Prepared Package of Boric Acid', when used as directed in Exhibits A and B in the canning of vegetables, fruits, pickles and preserves is safe and appropriate for such uses, and will effect proper sterilization, conservation and preservation of home canned foods, whereas, use of said 'Mrs. Price's Specially Prepared Package of Boric Acid', as directed, is potentially dangerous to the health of the consumer, and will not insure proper sterilization, conservation and preservation of home canned foods. VIT "The' article of food, labeled in part, 'Price!s No Ice', is misbranded within the meaning of Section 403 (a) of the Act in that the following statements appearing in Exhibits E and F, to wit, '* '* * can. be used in milk or cream to prevent souring', and 'It keeps the fish or "game sweet and .wholesome for days after being killed, even in the warmest weather, when directions are followed, and is removed by rinsing in cold water', * * '* and the statement, 'It keeps the fish or game sweet and wholesome for several days after being killed, even in the warmest weather, when directions are followed, and is removed by rinsing in cold water,' ? * * is false and misleading since the article when so used will not have such effects and will not be removed by rinsing in cold water. VIII "During all the times since the enactment of the Federal Food, Drug and Cosmetic Act shipments in interstate commerce of the products labeled in part, 'Mrs. Price's Compound', 'Mrs. Price's Specially Prepared Package of Boric Acid' and 'Price's No Ice' have been and now are in violation of Section 301 (a) of the Act." On June 28, 1943, judgment was entered enjoining the defendant, her employ- ees, agents, distributors, attorneys, assigns, and any and all persons acting in con- cert with her, from Introducing or delivering for introduction, or causing the in- troduction or delivery for introduction into interstate commerce of Mrs. Price's Compound, Price's No Ice, and Mrs. Price's Specially Prepared Package of Boric Acid, or any similar articles containing boric acid for any purposes whatsoever, in violation of the Federal Food, Drug, and Cosmetic Act. The complaint alleged further that the product, "Mrs. Price's Specially Prepared Package of Boric Acid," was a drug, as reported in notices of judgment on drugs and devices.