On October 19, Toby McAdam sued FDA to restrain FDA from further action until FDA puts in place criteria for a dietary supplement labels and clarify what constitutes a medical or drug claim on FDA's website, holding all dietary supplements to the same standards. McAdam also requested to be compensated for lost revenues by FDA preventing him from selling his formula of "black salve" for $8,000 per month since November 5, 2010 and to reimbursed for his expenses to hire a "label expert" for $3,600.
McAdam appears to have filed the Complaint himself, alleging that FDA's actions "puts the health of the general public at risk." According to the complaint, McAdams believes that he was treated differently that other similarly-situated parties that manufacture dietary supplements.
Starting in May 2007 until present, the complaint states, FDA notified McAdams that the dietary supplements that McAdams's company manufactures contain "medical claims." McAdams asserts that he "attempted to comply with every request and has submitted labels and wording that are similar and even more compliant than those companies similarly situated." McAdams' complaint continues that he can provide web sites, labels, and other documents to substantiate these facts "beyond any reasonable doubt that he is in fact being treated and prosecuted differently than those similarly situated." Later in the complaint, McAdams indicates that he recorded communications with FDA representatives after so informing the officials, which McAdams appears to include as part of his evidence of unequal treatment.
The complaint explains that the November 5, 2010 date is critical, because on or about this date, "Plaintiff was coerced to enter into a consent decree with Defendants. Plaintiff had not choice as to the issue and agreed under protest, also at the time of signing the decree Mr. McAdam was under pain management medication." The complaint then appears to explain that the consent decree included a requirement for McAdams to retain a dietary supplement labeling expert to come into compliance, which cost him $3,600. McAdams believes that if FDA had "model or sample acceptable label that they could have recommended to Plaintiff the supposed label expert issue could have been avoided." When McAdams was "forced" to remove certain language from his products that "stated intended purpose or use", he was "at risk for product liability where other companies similarly situated are allowed," the complaint further alleges.
While the complaint does not list all of the products at issue, it does mention a product "black salves" and that McAdams was prohibited from selling external products that contain "bloodroot" or "graviola" but may sell these herbs if taken internally. McAdams asserts that other companies can sell external products with bloodroot and graviola or have been selling black salves on the Internet, "thus holding and subjecting Plaintiff to a higher standard than those similarly situated." McAdams also alleges that FDA has prevented him from including information about the ingredients in his products and possible warnings or contraindications, noting how this differs from how FDA treats the prescription drug warfarin.
At this point, no other documents appear to be in the docket. A quick search of FDA's warning letters reveals the following Warning Letter to Ms. Great Armstrong, Risingsun Health Alternatives and Herbs, Division of McAdam Health Enterprises, which is based in Livingston, Montana, as is Mr. McAdam. This Warning Letter was issued on April 6, 2006, earlier than the dates in McAdams's Complaint, but also concerns various black salve formulations that contain bloodroot and graviola. To the extent this letter was not directed to the same Toby McAdams in the complaint, it does appear to provide FDA's opinion on these types of products. According to FDA's Warning Letter, these products are sold as topical and oral treatments for various forms of cancer, heart disease, high blood pressure, diabetes, and other life-threatening diseases. Some of the products are also indicated for pets. FDA's Warning Letter explains that the intended uses to treat these various diseases are "drug" claims as defined by 21 U.S.C. ยง 321(g) that are being marketed with out approval as new drugs or new animal drugs. The Letter continues that the topical products cannot be considered dietary supplements because the ingredients are not ingested but "both disease and structure/function claims cause them to be new drugs." The ingested products, the Letter adds, are misbranded, because they fail to bear adequate direction for use and require new drug approval to be marketed for their intended uses.
To McAdams's claims that other companies were treated differently, FDA does include other warning letters to manufactures of black salve products, e.g., to Generation's Black Salve in May 2008, to Can-X Products in December 2004, and some of these and other manufactures of similar products in FDA's website, 187 Fake Cancer "Cures" Consumers Should Avoid.
So while McAdams does not appear to stand alone in FDA's enforcement actions on black salve products or similar products with claims deemed to be "drug" claims, perhaps one idea McAdams had is worth monitoring: whether FDA will post additional information to differentiate drug claims from dietary supplement or products intended for external use, such as cosmetics, in a new or updated website or guidance dedicated to this issue.
