
[Federal Register Volume 76, Number 193 (Wednesday, October 5, 2011)]
[Rules and Regulations]
[Pages 61565-61566]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-25479]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Chapter I

[Docket No. FDA-2011-N-0527]


Preemption Review

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification of preemption review.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that it 
has determined, after conducting a review of its existing regulations 
issued within the past 10 years that contain statements in regulatory 
preambles or codified provisions intended by the Agency to preempt 
State law, that three FDA regulatory preambles contain or refer to 
statements about preemption that are not legally justified. FDA 
conducted this review in response to the President's May 20, 2009, 
``Memorandum for the Heads of Executive Departments and Agencies,'' 
which outlined the Administration's policy on preemption, in keeping 
with the principles in Executive Order 13132 on Federalism. The 
President's memorandum included a directive that such a review be 
conducted. FDA is also taking this opportunity to clarify certain 
preamble statements related to preemption resulting from express 
preemption provisions in the Federal Food, Drug, and Cosmetic Act (FD&C 
Act) concerning nonprescription drugs and food labeling.

DATES: Effective October 5, 2011.

FOR FURTHER INFORMATION CONTACT: Catherine Lorraine, Office of Policy, 
Office of the Commissioner, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 32, Rm. 4258, Silver Spring, MD 20993, 301-796-
4830.

SUPPLEMENTARY INFORMATION: On January 24, 2006 (71 FR 3922), FDA 
published a final rule entitled ``Requirements on Content and Format of 
Labeling for Human Prescription Drug and Biological Products'' 
(physician labeling rule). In the preamble to the physician labeling 
rule, FDA discussed its views on the preemptive effect of both the 
regulation's codified provisions and, more generally, the FD&C Act. In 
addition, FDA subsequently published two final rules with preambles 
that referenced the preemption discussion in the physician labeling 
rule. See ``Exceptions or Alternatives to Labeling Requirements for 
Products Held by the Strategic National Stockpile'' (72 FR 73589, 
73595, December 28, 2007); ``Supplemental Applications Proposing 
Labeling Changes for Approved Drugs, Biologics, and Medical Devices'' 
(73 FR 49603, 49605-49606, August 22, 2008).
    In its decision in Wyeth v. Levine, the Supreme Court addressed the 
preamble to the physician labeling rule and provided additional 
guidance in evaluating the preemptive effect of the FD&C Act and FDA 
regulations. 129 S. Ct. 1187 (2009). In this case, the Court upheld a 
State tort claim that was based on the manufacturer's failure to 
provide adequate warnings on the labeling of one of its prescription 
drug products. The Court held that the State claim was not preempted by 
the FD&C Act or FDA's labeling requirements, despite the Agency's 
position in the preamble to the physician labeling rule that such 
claims frustrate its statutory mandate.
    According to the Court, FDA's position ``does not merit 
deference,'' in part, because it is ``at odds with what evidence we 
have of Congress' purposes.'' Id. at 1201. The Court found that 
Congress's ``silence on the [preemption] issue, coupled with its 
certain awareness of the prevalence of state tort litigation, is 
powerful evidence that Congress did not intend FDA oversight to be the 
exclusive means of ensuring drug safety and effectiveness.'' Id. at 
1200. While the Court acknowledged that ``some state-law claims might 
well frustrate the achievement of congressional objectives,'' it found 
that ``failure-to-warn claims'' such as the one at issue do not 
``obstruct the federal regulation of drug labeling.'' Id. at 1204. The 
Court also noted that the manufacturer did not avail itself of FDA 
regulations that permit changes to a drug's labeling. Id. at 1996-97. 
And ``absent clear evidence that the FDA would not have approved'' the 
type of warning deemed necessary by the State claim, the Court was not 
willing to ``conclude that it was impossible'' for the manufacturer 
``to comply with both federal and state requirements.'' Id. at 1198.
    In light of the Supreme Court's decision in Wyeth, FDA has 
concluded that the position on preemption articulated in the preamble 
to the physician labeling rule, and subsequently referred to in the 
preambles of the other two rules cited previously in this document, 
cannot be justified under legal principles governing preemption. The 
codified provisions in these rules, however, do not include any 
statements about preemption and would not preempt State law beyond 
governing principles of preemption. FDA's conclusion about the 
regulatory preambles, therefore, does not affect the validity or 
operation of the codified provisions in these three final rules.
    FDA also would like to clarify past preamble statements related to 
preemption resulting from certain express preemption provisions in the 
FD&C Act concerning nonprescription drugs and food labeling. Some 
preamble statements in regulations on nonprescription drugs contain the 
following language: ``Currently, [Section 751(a) of the FD&C Act (21 
U.S.C. 379r(a))] operates to preempt States from imposing requirements 
related to the regulation of nonprescription drug products (See section 
751(b) through (e) of the act for the scope of the express preemption 
provision, the exemption procedures, and the exceptions to the 
provision) * * *. Although this final rule would have a preemptive 
effect, in that it would preclude States from issuing requirements 
related to these OTC * * * drug products that are different from or in 
addition to, or not otherwise identical with a requirement in the final 
rule, this preemptive effect is consistent with what Congress set forth 
in section 751 of the act. Section 751(a) of the act displaces both 
State legislative requirements and State common law duties * * *.''

(See, e.g., 74 FR 9759, March 6, 2009; 73 FR 6015, February 1, 2008; 72 
FR 71769, December 19, 2007; 72 FR 14669, March 29, 2007; 72 FR 9849, 
March 6, 2007; 71 FR 43358, August 1, 2006). This language could be 
read to suggest that FDA does not read section 751 of the FD&C Act as a 
whole and gives more significance to some provisions, e.g., subsection 
751(a), than others, e.g., subsection 751(e) (which makes clear that 
section 751 does not affect any action under a state's product 
liability law). FDA now clarifies that it does read section 751 of the 
FD&C Act as a whole, in that each subsection must be read together with 
the other subsections.

    In addition, FDA is now clarifying preamble statements in 
regulations on food labeling that contain the following language: 
``Although this rule has a pre-emptive effect, in that it would 
preclude states from issuing any * * * requirements * * * that are not 
identical to those required by the final rule, this pre-emptive effect 
is consistent with what Congress set forth in Section 403A of the Act 
[21 U.S.C. 343-1].'' (See, e.g., 74 FR 2443, January 15, 2009). 
Although this language reflects the statutory language in section 403A 
of the FD&C Act, as codified at 21 U.S.C. 343-1, it does not 
acknowledge

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the applicability limitation set forth in section 6(c)(2) of the 
Nutrition Labeling and Education Act (NLEA), which was not codified. 
Section 6(c)(2) of the NLEA provided that section 403A of the FD&C Act 
``shall not be construed to apply to any requirement respecting a 
statement on the labeling of food that provides for a warning 
concerning the safety of the food or component of the food'' (Pub. L. 
101-535, section 6, 104 Stat. 2353 (1990)). FDA clarifies that its past 
discussions of section 403A of the FD&C Act should have included the 
language of section 6(c)(2) of the NLEA.

    Dated: September 28, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-25479 Filed 10-4-11; 8:45 am]
BILLING CODE 4160-01-P


