Opinion ID: 2572676
Heading Depth: 1
Heading Rank: 3

Heading: is there a direct conflict between the warning required by proposition 65 and the orders of the fda?

Text: The language required by the FDA's August 17, 2001, letter is not necessarily inconsistent with a Proposition 65 warning to consumers that defendants' products contain nicotine, a chemical known to cause reproductive harm. The apparent conflict arises from the FDA's insistence that defendants must use the warning it has promulgated unless they have data to support a different warning. The FDA has rejected plaintiff's claim that his data justify a different warning, and defendants do not claim to have any additional data. Thus, if a defendant were to add a warning to its label advising that nicotine can cause fetal harm, it would violate the FDA's determination and would risk legal sanctions. Plaintiff contends, however, that the FDA action is not sufficiently definite and authoritative to create a conflict with state law. Before August 17, 2001, the FDA had regularly sent letters instructing defendants not to add any additional warnings to the FDA-approved warning, and cautioning them that adding such additional warnings might render the product misbranded. Some letters advised the recipient that the matter was still under consideration. But amicus curiae United States Attorney General, on behalf of the FDA, acknowledges: Before its disposition of Dowhal's citizen petition [by the August 17, 2001, letter], FDA had not issued definitive advice concerning whether use of Dowhal's proposed warning labeling would render Defendants' products misbranded under the FDCA. The FDA takes the position that its August 17 letter was the first definitive ruling on the subject. The FDA's August 17 letter specifically rejected plaintiff's proposed can harm your baby warning. (Aug. 17, 2001, letter, p. 8.) It did not expressly reject all possible Proposition 65 warnings. It announced, however, that the FDA had developed a uniform warning that manufacturers ... will be requested to implement. ( Id. at p. 5.) Rejecting all earlier warnings, including both the fetal heart rate warning used by defendants and the can harm your baby warning used on Habitrol, the FDA said that the label should instead tell the buyer to consult her health care provider for advice. Manufacturers were requested to submit a supplement changing their warning to conform to the warning in the August 17 letter. ( Id. at pp. 7-8.) Plaintiff argues that the FDA's August 17 letter did not establish a required federal warning, but merely requested defendants to submit supplements. But the term requested appears to be simply a matter of courtesy; it is apparent from the tenor of the letter that it imposes a duty on defendants. A company cannot use warnings the FDA considers misleading simply because it chooses not to comply with an FDA request to submit the forms required to change its warnings to the one adopted by the FDA. Plaintiff and his amici curiae point to language in the FDA's August 17 letter stating that [a]ny other warnings proposed by the sponsor must be supported by data, as showing that defendants are not required to use warnings identical to the FDA warning. But this is standard language that appears, or is implied, in all FDA labeling decisions. A company is always free to change its label, after notifying the FDA, if it has new data showing the former warning was inappropriate. (See 21 C.F.R. § 314.70 (2003).) The possibility that new data may justify a change in the warning does not invalidate the approval of the existing warning; that warning continues to be binding until the new data emerge and a change is requested. Plaintiff and his amici curiae point out that the FDA's August 17 letter has not been published in the Federal Register. There is no requirement, however, that it be so published to be effective. Congress was undoubtedly aware that one common means of FDA regulation is to publish rulings through letters to the parties requesting the rulings. When Congress granted preemptive effect to FDA regulation as to all state regulation except Proposition 65 regulation, it probably had in mind regulation through FDA advisory letters. In Geier, supra, 529 U.S. 861, 120 S.Ct. 1913, the United States Supreme Court gave preemptive effect to a federal policy expressed in less formal manner than the FDA policy here. Rejecting a contention that formal notice-and-comment rulemaking should be required before an agency's action has preemptive force, the high court found federal policy to be sufficiently definite as to create a conflict when that policy was set out only in comments of the Department of Transportation accompanying its revision of the airbag rules and in statements in the Solicitor General's brief submitted on the agency's behalf. ( Id. at pp. 883-884, 120 S.Ct. 1913.) Plaintiff here contends that although the FDA has rejected several proposed labels based on Proposition 65, defendants cannot prevail on their motion for summary judgment unless all possible Proposition 65 labels would conflict with the FDA's determination. (See Dental Amalgam Mfrs. & Distributors v. Stratton (9th Cir.1996) 92 F.3d 807, 810; Chemical Specialties Mfrs. Ass'n, Inc. v. Allenby (9th Cir.1992) 958 F.2d 941, 943; People ex rel. Lungren v. Cotter & Co. (1997) 53 Cal.App.4th 1373, 1393, 62 Cal.Rptr.2d 368.) The FDA seeks to prohibit any warning not identical to its own, but the absence of identical language is not enough to justify preemption, since the savings clause specifically allows state regulations that are different from ... [or] otherwise not identical to FDA requirements. (21 U.S.C. § 379r(a)(2).) In this case, however, any warning that conformed in substance to the FDA's warning would not comply with Health and Safety Code section 25249.6 because it would not provide clear and reasonable warning to the consumer that the product contained a chemical known ... to cause ... reproductive toxicity. Thus, the FDA determination has effectively barred all warnings on labels that comply with Proposition 65. Finally, plaintiff and his amici curiae point out that Proposition 65 warnings need not appear on labels; warnings can also be conveyed through point-of-sale notices or public advertising. (Cal.Code Regs., tit. 22, § 12601.) Because the FDA regulates only product labeling, they contend that a Proposition 65 warning conveyed through other means cannot be preempted. The FDA's ruling, however, reflects the concern that Proposition 65 warnings on product labels might lead pregnant women to believe that NRT products were as dangerous as smoking, or nearly so, and thus discourage the women from stopping smoking. Warnings through point-of-sale posters or public advertising could have the same effect of frustrating the purpose of the federal policy. Conflict preemption does not require a direct contradiction between state and federal law; the state law is preempted if state law `stands as an obstacle to the accomplishment and execution of the full purposes and objectives of Congress.' ( English v. General Electric Co., supra, 496 U.S. at p. 79, 110 S.Ct. 2270.) We conclude that the FDA's August 17, 2001, letter established a federal policy prohibiting defendants from giving consumers any warning other than the one approved by the FDA in that letter, and that the use of a Proposition 65 warning would conflict with that policy.