Both district court decisions stem from a lawsuit the NRDC, et al. filed in 2011 (see our previous post here). The groups allege in their Complaint that FDA, in violation of the Administrative Procedure Act (“APA”), failed to comply with the Agency’s statutory duty to withdraw approvals of subtherapeutic uses of penicillin and tetracyclines in animal feed as required by FDC Act § 512(e)(1) (21 U.S.C. § 360b(e)(1)) and as proposed in 1977. That statutory provision, which addresses FDA’s authority power to withdraw approval for new animal drugs, states:(1) [FDA] shall, after due notice and opportunity for hearing to the applicant, issue an order withdrawing approval of an application filed pursuant to subsection (b) of this section with respect to any new animal drug if the Secretary finds . . .(B) that new evidence not contained in such application or not available to the Secretary until after such application was approved, or tests by new methods, or tests by methods not deemed reasonably applicable when such application was approved, evaluated together with the evidence available to the Secretary when the application was approved, shows that such drug is not shown to be safe for use under the conditions of use upon the basis of which the application was approved . . . ;The Plaintiffs further contend that FDA’s failure to timely respond with final decisions to Citizen Petitions submitted to th

Alternatively, FDA asserts that even if the Court concludes that the PTE statute is ambiguous, the Court should defer to FDA’s interpretation because it is reasonable.Reviewing the district court’s grant of sumary judgment de novo, the Federal Circuit ruled that 35 U.S.C. § 156(g) is ambiguous, but that FDA’s interpretation of the PTE statute is permissible under a Chevron Step 2 analysis:Section 156(g) created a range of ambiguity by not explicitly defining the term “application,” leaving that term open to interpretation. FDA’s interpretation tracks the requirements of 21 U.S.C. § 360b(b). As explained by FDA, the administrative NADA is the first document containing or referencing all of the parts required by 21 U.S.C. § 360b(b).

Warning letter language often states that the offending product is a:“new animal drug, as defined by section 201(v) of the FD&C Act, 21 U.S.C. 321(v), because it is not generally recognized among experts qualified by scientific training and experience to evaluate the safety and effectiveness of animal drugs, as safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling. To be legally marketed, a new animal drug must have an approved new animal drug application, conditionally approved new animal drug application, or index listing under sections 512, 571, and 572 of the FD&C Act, 21 U.S.C. 360b, 360ccc, and 360ccc-l.”Companies that receive warning letters from the FDA must take “prompt” legal action to correct the identified violations, and are subsequently warned that failure to make a corrective change could result in additional legal action.

[The] products are misbranded drugs under section 502(f)(1) of the FD&C Act, 21 U.S.C. 352(f)(1).3. [The] “Bido CBD for Pets” products are unapproved new animal drugs that are unsafe under section 512(a) of the FD&C Act, 21 U.S.C. 360b(a), and adulterated under section 501(a)(5) of the FD&C Act, 21 U.S.C. 351(a)(5).The letter goes on to note that the company is marketing “unapproved new and misbranded human drug products” and making unsubstantiated medical claims about the cannabis products it sells.

The important distinction for the cannabis industry is that the FDA labeled Canna-Pet products as drugs not because they contained cannabis or cannabis extracts, but because the Canna-Pet products were, “intended to mitigate, treat, or prevent disease in animals, it is a drug.” Under 21 U.S.C. §§ 360b, 360ccc and 360ccc-1, new animal drug products must be approved pursuant to a new animal drug application, the subject of a conditionally approved new animal drug application, or an index listing, respectively. Without these approvals, the FDA will find products for animals meeting the definition of a drug to be unsafe and adulterated under the FDCA.

The court also found that compounded veterinary drugs fall within the statutory definition of “new animal drug.” It acknowledged, however, that compounded veterinary drugs are exempt from the FDA approval requirement if they meet the criteria established by the 1994 Animal Medicinal Drug Use Clarification Act (“AMDUCA”).Codified at 21 U.S.C. §360b(a)(4), (5), AMDUCA permits the compounding of veterinary drugs using FDA-approved human and animal drugs upon the order of a licensed veterinarian and subject to FDA discretion as to whether the drug poses a risk to public health.The Fifth Circuit's decision could increase the confusion over the legal status of compounding.Pharmacists in the Ninth Circuit cannot claim protection by section 503A, while pharmacists in the 5th Circuit can.The status of the law elsewhere in the country remains an open question.