                                            G R E G     A B B O T T




                                                 March 6,2007


Mr. Ronald Ensweiler, President                             Opinion No. GA-0525
State Committee of Examiners in the Fitting
   and Dispensing of Hearing Instruments                    Re: Constitutionality of provisions of the
1 100 West 49th Street                                      Occupations Code, which prohibit the fitting
Austin, Texas 78756-3 183                                   and dispensing of hearing instruments ordered
                                                            by mail by an unlicensed individual and the sale
                                                            of a hearing instrument by mail (RQ-0524-GA)

Dear Mr. Ensweiler:

         You ask several questions about two provisions in the Occupations Code governing hearing
instruments.' As background you inform us that two Illinois corporations sell "hearing instruments
through the mail in all states including Texas." Request Letter, supra note 1, at 1. You further
inform us that though licensed in Illinois, neither company is licensed in Texas to "fit and dispense
or sell hearing aids in Texas." Id. You ask:

                  1.    Whether Occupations Code[] § 402.451(a)(6) (1999), which
                        prohibits the fitting and dispensing of hearing instruments by
                        anyone without a license, violates the "dormant commerce
                        clause" of the U.S. Constitution, Art. I, 5 8, C1.3[.]

                 2.     Whether Occupations Code 5 402.45 1(a)(7) (1 999), which
                        prohibits the sale by anyone from selling hearing instruments by
                        mail, whether licensed or not, violates the "dormant commerce
                        clause" of the U.S. Constitution, Art. I, 5 8, C1. 3[.]

                  3.    Can the State of Texas justify the discrimination, both in terms
                        of the local benefits flowing from the statute and the
                        unavailability of nondiscriminatory alternatives adequate to
                        preserve the local interests at stake?




         'See Letter from Mr. Ronald Ensweiler, President, State Committee of Examiners in the Fitting and Dispensing
of Hearing Instruments, to Honorable Greg Abbott, Attorney General of Texas, at 2 (Aug. 10, 2006) (on file with the
Opinion Committee, also available at http:/lwww.oag.state.tx.us) [hereinafter Request Letter].
Mr. Ronald Ensweiler - Page 2                 (GA-0525)



               4.    Whether Occupations Code[] $ 402.45 1(a)(7) (1999)[] violates
                     the "dormant commerce clause" because it imposes burdens on
                     interstate commerce greater than the local benefits secured[.]

               5.    Whether Occupations Code $ 402.451(a)(7) (1999) is
                     arbitrary[.]

               6.    Whether the Federal Food, Drug and Cosmetic Act, 21
                     U.S.C.A. $360 (1976) and 21 C.F.R. $5 801.420 and 801.421
                     (2003)[,] pre-empts Occupations Code[] 8 402.45 1(a)(6)[,] (7)
                     (1999)L.I

               7.    Does the Federal Food, Drug and Cosmetic Act, 21 U.S.C.A.
                     $ 360 (1976) and 21 C.F.R. $8 801.420 and 801.421 (2003)[,]
                     provide for a cut-off date whereby a State can request an
                     exemption from pre-emption, and does the failure to previously
                     ask for [an exception] on the sales by mail issue preclude asking
                     for an exception now?

Id. at 2.

         The two state law provisions about which you ask are contained in section 402.451,
Occupations Code, which pertains to prohibited acts for hearing instrument fitters and dispensers.
See Request Letter, supra note 1, at 1;see also TEX.OCC.CODEANN. $ 402.45 1(a)(6)-(7) (Vernon
2004). Subsection 402.45 1(a)(6) prohibits a person from dispensing or fitting "a hearing instrument
on a person who has ordered the hearing instrument or device by mail unless the person dispensing
or fitting is a license holder under [Chapter 4021 or under Chapter 401." Id. $ 402.451(a)(6).
"Fitting and dispensing hearing instruments" is defined in relevant part to mean the "measurement
of human hearing by the use of an audiometer or other means to make selections, adaptations, or
sales of hearing instruments." Id. $ 402.001(4); 22 TEX.A     D  m  .CODE$ 141.2(15) (2006) (State
Comm. of Exam'rs in the Fitting & Dispensing of Hearing Instruments, Definitions). Through this
definition of "fitting and dispensing hearing instruments" and the statutory requirements of
subsection 402.45 1(a)(6), there is a requirement that a person licensed under Texas law perform an
audiological exam on a person who has ordered a hearing aid by mail. Subsection 402.451(a)(7)
prohibits the sale of a "hearing instrument by mail." TEX.OCC.CODEANN.$ 402.45 1(a)(7) (Vernon
2004). The "selling of a hearing instrument by mail" means "[alnytime a hearing instrument is
not sold, fitted or dispensed in person by a licensee or permit holder." 22 TEX.A       D  m  .CODE
$ 141.2(23) (2006). Thus, at issue in this request are both the requirement of an audiological
examination and the prohibition against hearing aids ordered by mail.

        Several of your questions relate to the constitutionality of these two provisions. See Request
Letter, supra note 1, at 2. A court will usually decide a constitutional question only when it cannot
resolve the issue on nonconstitutional grounds. See In re B.L.D.,     113 S.W.3d 340,349 (Tex. 2003).
Because two of your questions are not related to the constitutionality of the Occupations Code
Mr. Ronald Ensweiler - Page 3



provisions but rather pertain to preemption issues concerning the two provisions, we will do likewise
and consider them first.

        You ask whether subsections 402.45 1(a)(6) and (a)(7) are preempted by federal legislation.
See Request Letter, supra note 1, at 2. Under the Supremacy Clause of the United States
Constitution, the laws of the United States are "the supreme Law of the Land; . . . any Thing in the
Constitution or Laws of any State to the Contrary notwithstanding." U.S. CONST.art. VI, cl. 2. It
is well settled that a state law conflicting with federal law is "without effect." Maryland v.
Louisiana, 451 U.S. 725, 746 (1981); Am. Cyanamid Co. v. Geye, 79 S.W.3d 21,23 (Tex. 2002).
"Consideration of issues arising under the Supremacy Clause 'start[s] with the assumption that the
historic police powers of the States [are] not to be superseded by . . . Federal Act unless that [is] the
clear and manifest purpose of Congress.' Accordingly, '[tlhe purpose of Congress is the ultimate
touchstone' of pre-emption analysis." Cipollone v. Liggett Group, Inc., 505 U.S. 504, 516 (1992)
(citations omitted). Congressional intent with respect to preemption may be express or implied. See
Hillsborough County, Flu. v. Automated Med. Labs., Inc., 471 U.S. 707, 713 (1985). State law is
expressly preempted when Congress uses clear preemptive language in the federal statute or
regulation. See id. (recognizing state laws can be preempted by federal regulations as well as by
federal legislation). Absent express preemptive language, a federal statute or regulation impliedly
preempts state law when the language indicates a Congressional intent to exclusively and completely
occupy a legislative field. See Cipollone, 505 U.S. at 516. State law is also impliedly preempted
when it actually conflicts with the federal law in such a way that "compliance with both federal and
state regulations is a physical impossibility." Hillsborough County, Flu., 471 U.S. at 713.

        We need here consider only express preemption because there is an express preemption
provision in the federal statute. See 21 U.S.C.A. 5 360k(a) (West 1999); see also Cipollone, 505
U.S. at 517 ("When Congress has considered the issue of pre-emption and has included in the
enacted legislation a provision explicitly addressing that issue, and when that provision provides a
'reliable indicium of congressional intent with respect to state authority'. . . 'there is no need to infer
congressional intent to pre-empt state laws from the substantive provisions' of the legislation.")
(citations omitted). In the Medical Device Amendment (the "MDA"), which gives the Food and
Drug Administration (the "FDA") jurisdiction over medical devices, Congress preempted state laws
that pertain to medical devices intended for human use and that impose any requirement:

                (1) which is different from, or in addition to, any requirement
                applicable under this chapter to the device, and

                (2) which relates to the safety or effectiveness of the device or to any
                other matter included in a requirement applicable to the device under
                this chapter.

2 1 U.S.C.A. 5 360k(a) (West 1999);see also Medical Device Amendments of 1976, Pub. L. No. 94-
295, 90 Stat. 539 (1976) (codified as amended at 21 U.S.C. $5 301-91); Federal Pure Food and
Drugs Act of 1906, Pub. L. No. 59-384,34 Stat. 768 (1906). A hearing aid is a "device" under the
Federal Food, Drug, and Cosmetic Act. See 21 U.S.C.A. 5 321(h) (West 1999). Thus, we must
Mr. Ronald Ensweiler - Page 4                  (GA-0525)



consider the scope of the express exemption in section 360k(a) and determine whether subsections
402.45 1(a)(6) and (a)(7) fall within the scope of that preemption. See Medtronic, Inc. v. Lohr, 5 18
U.S. 470, 484 (1996) ("While the pre-emptive language of 8 360k(a) means that we need not go
beyond that language to determine whether Congress intended the MDA to pre-empt at least some
state law, we must nonetheless 'identify the domain expressly pre-empted' by that language.")
(citation omitted); cJ: Smith v. Pingree, 65 1 F.2d 1021, 1023 (5th Cir. 1981) (setting out method of
analyzing state hearing-aid regulation).

        The first prong of the preemption analysis inquires whether the two subsections impose
requirements that are different from, or in addition to, requirements imposed under the MDA. In its
hearing aid regulation adopted under the MDA, the FDA established "uniform professional and
patient labeling requirements and conditions for sale of hearing aid devices." 42 Fed. Reg. 9286
(Feb. 15,1977). The FDA rule contains a provision governing medical evaluations, which provides

               (1) General. Except as provided in paragraph (a)(2) of this section,
               a hearing aid dispenser shall not sell a hearing aid unless the
               prospective user has presented to the hearing aid dispenser a written
               statement signed by a licensed physician that states that the patient's
               hearing loss has been medically evaluated and the patient may be
               considered a candidate for a hearing aid. The medical evaluation
               must have taken place within the preceding 6 months.

               (2) Waiver to the medical evaluation requirements. If the
               prospective hearing aid user is 18 years of age or older, the hearing
               aid dispenser may afford the prospective user an opportunity to waive
               the medical evaluation requirement of paragraph (a)(l ) of this section
               provided that the hearing aid dispenser [provides certain information
               and the specified waiver form].

2 1 C.F.R. 5 801.421(a) (2006). The regulation restricts the sale of a hearing aid to an individual who
has undergone a medical evaluation in the past six months, but allows a fully informed adult to
waive the evaluation. In fact, the FDA entertained comments about the necessity of the waiver
provision and determined that a waiver opportunity was necessary to protect the freedom of those
who have religious or personal beliefs against a medical examination and for the circumstances
where an individual would have great difficulty obtaining a medical examination. See 42 Fed. Reg.
9286, 9292-93 (Feb. 15, 1977). The FDA expressly decided to make the medical evaluation
optional under the MDA. In contrast, subsection 402.451(a)(6) requires an evaluation but does
not contain any provision authorizing a waiver of the evaluation. See TEX. OCC. CODEANN.
5 402.45 1(a)(6) (Vernon 2004). Under subsection 402.45 1(a)(6), the audiological evaluation is not
optional. The state provision imposes a requirement that is different from, or in addition to, a
requirement in the MDA.

        Similarly, the federal hearing aid regulation does not contain a prohibition against the sale
of hearing aids through the mail. See 21 C.F.R. 5 801.421 (2006). And as it did with the medical
Mr. Ronald Ensweiler - Page 5                   (GA-0525)



evaluation requirement, the FDA considered imposing a prohibition against mail ordered hearing
aids but expressly rejected the idea. See 42 Fed. Reg. 9286, 9293 (Feb. 15, 1977) ("The
Commissioner is not aware of any abuses in mail order sales of hearing aids . . . . The Commissioner
has determined not to prohibit mail order sales provided that all the requirements of the regulation
have been met."). On the other hand, subsection 402.45 1(a)(7) prohibits the sale of hearing aids by
mail. Such a prohibition is a requirement that is different from or in addition to the requirements of
the MDA.

          The second prong of the preemption analysis requires consideration of the safety and
effectiveness of the device. See 21 U.S.C.A. 5 360k(a)(2) (West 1999). With respect to the
audiological examination required by subsection 402.45 1(a)(6), the FDA has concluded that a state
requirement of "audiological evaluation relates to the safety or effectiveness of hearing aids because
it is intended to ensure that the purchaser is fitted properly with a hearing aid." 45 Fed. Reg. 67326,
67327 (Oct. 10,1980) (final rule codified at 21 C.F.R. pt. 808). The FDA stated that an audiological
exam aids in determining "the cause of, and pathology associated with, a patient's hearing loss" and
is "based upon the recognition that an unnecessary or partially effective hearing aid device may be
substituted for primary medical or surgical treatment, thus depriving the hearing impaired patient of
benefit of appropriate medical diagnosis and care and resulting in a detriment to health." 42 Fed.
Reg. 9286, 9287-88 (Feb. 15, 1977). Such considerations clearly pertain to the safety and
effectiveness of a hearing aid.

        The prohibition against mail-ordered hearing aids contained in subsection 402.45 1(a)(7)
similarly relates to the safety and effectiveness of a hearing aid. The prohibition essentially requires
the sale of hearing aids in person. See 22 TEX.ADMIN.CODE5 141.2(23) (2006) (defining "selling
of hearing instrument by mail" as "not sold, fitted or dispensed in person"). In our opinion, a
requirement that the sale of hearing aids be in person is a requirement designed to improve the
effectiveness of the hearing aid and thus pertains to the safety and effectiveness of the hearing aid.

        Because both subsections impose requirements that are different from, or in addition to, the
federal requirements and because both relate to the effectiveness and safety of a hearing aid device,
we believe the two subsections are expressly preempted by section 360k(a). Accordingly, we need
not consider your questions pertaining to the constitutionality of these two sections. See supra at
2-3.

        Your remaining question inquires whether the MDA and its regulations "provide for a cut-off
date whereby a State can request an exemption from pre-emption, and [whether] the failure to
previously ask for [an exception] on the sales by mail issue preclude[s] asking for an exception
now." Request Letter, supra note 1, at 2. The MDA authorizes a state or political subdivision to
seek an exemption from preemption. See 21 U.S.C.A. 5 360k(b) (West 1999). The FDA by
regulation, after notice and hearing, may exempt from preemption an applicable state requirement
if

                (1) the requirement is more stringent than a requirement under this
                chapter which would be applicable to the device if an exemption were
                not in effect under this subsection; or
Mr. Ronald Ensweiler - Page 6



               (2) the requirement -

                      (A) is required by compelling local conditions, and

                      (B) compliance with the requirement would not cause the
               device to be in violation of any applicable requirement under this
               chapter.

Id. The FDA regulations provide the procedures by which a state may seek an exemption. See 21
C.F.R. 5 808.20 (2006). Neither the statute nor the regulations provide a cut-off date by which a
state must apply for an exemption. See 21 U.S.C.A. 5 360k(b) (West 1999); 21 C.F.R. 5 808.20
(2006). While the FDA has not engaged in a formal rulemaking process on hearing aids recently,
we see no express indication that a state could not now apply for an exemption. In the last
rulemaking process, states were even encouraged to "remain active in regulating the hearing aid
industry." 45 Fed. Reg. 67326, 67326 (Oct. 10, 1980). Moreover, the statute and the regulations
have not been deleted or repealed for being unnecessary as would be expected if states were no
longer permitted to apply for an exemption. For these reasons, we believe that there is no cut-off
date by which a state or political subdivision must apply for an exemption. For the same reasons,
we also believe that a state's failure to previously request an exemption does not preclude it from
doing so now or in the future. We must point out, however, that the FDA has not construed the
meaning of its own rule with respect to a cut-off date by which to seek an exemption. See 43 Fed.
Reg. 18661 (May 2, 1978). Any reasonable interpretation of the rule by the FDA would, of course,
be given deference over a state attorney general's opinion. See Christensen v. Harris County, 529
U.S. 576, 588 (2000) ("an agency's interpretation of its own regulation is entitled to deference").
Mr. Ronald Ensweiler - Page 7



                                     S U M M A R Y

                      Subsections 402.45 1(a)(6) and 402.45 1(a)(7), Occupations
              Code, are preempted by the federal statutes and regulations governing
              hearing aid devices. However, no federal law or regulation imposes
              a cut-off date on a state's ability to request an exemption from
              preemption from the Food and Drug Administration (the "FDA"),
              although the extent to which such request receives consideration is
              subject to the FDA's discretion.

                                    Very truly yours,




                                    ~ t t o r n e w n e r aof
                                                           l Texas


KENT C. SULLIVAN
First Assistant Attorney General

ELLEN L. WITT
Deputy Attorney General for Legal Counsel

NANCY S. FULLER
Chair, Opinion Committee

Charlotte M. Harper
Assistant Attorney General, Opinion Committee
