James Harry Covington founded the law firm Covington & Burling
"The proof of intention in the criminal law," he said "does not mean the metaphysical reading of a man's mind. Specific proof of intent is not necessary; it may be established by evidence of attending facts and circumstances, and therefore the Government can easily show that a false statement on a label regarding a drug is one from which fraudulent intent may be implied. Conviction in all proper cases will be consequently comparatively sure."------ James Harry Covington
The misbranding section of the law did not explicitly refer to curative promises. A food or drug article was misbranded, the law stated, "the package or label of which shall bear any statement, design, or device regarding such article, or the ingredients or substances contained therein which shall be false or misleading in any particular." Wiley and Kebler, in their initial regulations, had aimed this general clause directly at unwarranted assertions that promised relief or cure. At the time questions were raised about the Bureau's interpretation. In view of the differences of opinion prevailing over matters therapeutical, a drug editor suggested, "it will be interesting to know who is to be judge of the truth or falsity of the therapeutical claims which may be made."  Certainly among medical practitioners an ancient therapeutic debate had reached a new and bitter stage. In the American Medical Association's effort to improve standards, Association spokesmen were condemning the healing practices of various sects and cults . These groups fought back with vigor, defending their therapies and opposing the AMA's effort to enforce therapeutic monopoly. While such a debate was going on, could Wiley and Kebler, perusing nostrum labels, find firm scientific grounds on which to approve or reject? They themselves took this for granted and, during the first years of the law, so did the trade. Many manufacturers toned down their therapeutic claims. Others did not, but when hauled into court admitted Wiley's view of the law's applicability by pleading guilty .
Out in Kansas City an eclectic physician named Johnson decided on a different legal course. He had been vending an assortment of tablets and liquids as "Dr. Johnson's Mild Combination Treatment for Cancer." For this purpose, of course, the concoctions were worthless. Johnson fulfilled the law's requirements as to the accurate labeling of his ingredients. It was solely against his false curative promises that the government brought its suit. The medicine man's lawyers moved to quash the indictment, pleading that Congress had not intended the law to forbid such practices. When the case had run its course, the Supreme Court had agreed. Oliver Wendell Holmes delivered the decision, a tortuous exploration of grammatical construction that could find no proper link between the prohibition of false labeling and assertions of healing potency. Congress was not apt to legislate, Holmes argued, in the debatable realm of what could cure and what could not. This would "distort the uses of its constitutional power to establishing criteria in regions where opinions are far apart." 
Charles Evans Hughes wrote a vigorous dissent. His study of the grammar of the law revealed the connection Holmes could not see. He cited the act's legislative history to show that Congress had indeed intended a prohibition of therapeutic nonsense on nostrum labels. Even the makers of medicines had generally assumed the law to be so written, Hughes pointed out, since so many had promptly entered pleas of guilt. Holmes had "impressively described," the dissenting justice said, the conflict that did indeed exist between schools of medicine and the difficulty of legislating in such an uncertain area. "But granting the wide domain of opinion," he added, "and allowing the broadest range to the conflict of medical views, there still remains a field in which statements as to the curative properties are downright falsehoods and in no sense expressions of judgment. This field I believe this statute covers." This type of downright falsehood was what Johnson had placed on the labels of his cancer cure.
But Holmes had the majority with him. The decision, wrote an incensed George Creel, was "first aid to fraud and murder," leaving the nostrum provisions of the law with "as much bite as a canton flannel dog." Wiley was angry. Maybe Holmes understood his opinion, the chief chemist said. I don't. All I can make out is that it gives anyone the right to lie about drugs whenever he feels like it." Wiley preferred to stand with Hughes. "He disagreed," the chemist added bitterly, "probably, because he had not been on the bench long enough to know better." 
The decision in the Johnson case, said President Taft, meant that over 150 cases of the same type pending in the courts, "involving some of the rankest frauds by which the American people were ever deceived," would have to be dismissed. He urged the Congress promptly to pass a law to plug the hole. Holmes had made clear—and Hughes had agreed—that "any attempt to legislate against mere expressions of opinion would be abortive." Thus the new law should proscribe only "knowingly false misstatements of fact as to the effect of the preparations." Such a measure, the President was persuaded, would control "the greater part of the evil." 
Congressman Swagar Sherley of Kentucky introduced a bill, and it was passed by Congress "without any blare of trumpets." The amendment to the food and drug law declared an article misbranded "if its package or label shall bear or contain any statement, design, or device regarding the curative or therapeutic effect of such article or any of the ingredients or substances contained therein, which is false and fraudulent." 
In view of the Johnson decision, "false and fraudulent" was as strong a phrase as Congress could very well enact. But would proving fraud be such an impossible task as to offer quackery an open road? Congressman Sherley acknowledged this hazard: "very frequently," he said, the government would have difficulty "in convicting the guilty man." A fellow Congressman, James Covington of Maryland, foresaw no untoward danger. "The proof of intention in the criminal law," he said "does not mean the metaphysical reading of a man's mind. Specific proof of intent is not necessary; it may be established by evidence of attending facts and circumstances, and therefore the Government can easily show that a false statement on a label regarding a drug is one from which fraudulent intent may be implied. Conviction in all proper cases will be consequently comparatively sure." 
Wiley was less cheerful. The dangers Congressman Sherley saw as likely, Wiley viewed as certain. The word "fraudulent" in the amendment, he said, was a "joker" which would nullify the law's intent. Congress had "given the manufacturers of fake cure-alls another lease on life and enabled the roots of fraud and corruption to sink deeper into the soil of protective legislation-protective to vested interests, not to public welfare." But enforcing the Sherley Amendment was not to be Harvey Washington Wiley's responsibility. Five months before Taft signed the law, Wiley had resigned his post as chief of the Bureau of Chemistry. The decision had been, perhaps, impending since 1906. The talents required for crusading in behalf of a law are not the same talents required for enforcing it. The measure was a pioneering one, and weaknesses in drafting became apparent, especially a lack of clarity as to enforcement responsibilities. Wiley's categorical stand against food preservatives antagonized industries with great political power, and this power they brought to bear. President Roosevelt, becoming unsure of Wiley's science, created checks upon his single-banded action within the Bureau which hamstrung the chief chemist. Bitter internecine warfare developed which, in Taft's administration, led to a charge of malfeasance against Wiley. Although he was vindicated by the President, Wiley felt that Taft should then have proceeded to oust his enemies and restore his authority. This the President did not do. Embittered, tired of fruitless fighting, and anxious to increase his income because of his recent marriage, Wiley quit .
In the whole protracted struggle, patent medicines played almost no part at all. One of Wiley's opponents within the Department of Agriculture had chided the chemist for working up weak food cases when so many strong cases might be developed against vicious nostrums sold within "the shadow of the National Capitol." Granted that the complaint possessed some merit, it has all the earmarks of a blow aimed at embarrassing Wiley in the continuing battle. At any rate, the Johnson case had already been decided against the government in the District Court