Can Texas ban mail-order hearing aid sales?

TX AG Opinion GA-0525: Are Texas's mail-order hearing aid bans federally preempted?

Plain-English summary

The president of the state board that licenses hearing-instrument fitters asked about two Occupations Code provisions, prompted by Illinois companies selling hearing aids by mail into Texas without a Texas license. Subsection 402.451(a)(6) bars dispensing or fitting a hearing aid ordered by mail unless the dispenser holds a Texas license, which (through the definition of "fitting and dispensing") effectively requires a Texas-licensed audiological exam. Subsection 402.451(a)(7) bars selling a hearing aid by mail at all, meaning the sale must happen in person. The board asked whether these rules violate the U.S. Constitution's dormant commerce clause and whether they are preempted by the federal Food, Drug, and Cosmetic Act and FDA regulations, and whether there is a cut-off date for a state to seek an exemption from preemption.

Because courts decide constitutional questions only when they cannot resolve a case on other grounds, the Attorney General took the preemption questions first. Under the Supremacy Clause, a state law that conflicts with federal law has no effect, and Congress can preempt expressly or impliedly. Here, the federal Medical Device Amendments contain an express preemption clause (21 U.S.C. section 360k(a)) that displaces state requirements about medical devices that are different from or in addition to federal requirements and that relate to the device's safety or effectiveness. A hearing aid is a "device" under the Act.

Applying that clause, the opinion concluded both Texas provisions are preempted. On the audiological exam: the FDA rule requires a medical evaluation before sale but lets an adult waive it (a choice the FDA deliberately preserved for people with religious or personal objections or who would have trouble getting an exam), while the Texas rule requires the evaluation with no waiver, so it adds to the federal requirement. On mail order: the FDA considered banning mail-order hearing aids and expressly declined, finding no abuses, while Texas bans them outright, again a different or additional requirement. Both requirements relate to safety and effectiveness (the FDA itself has said an audiological evaluation and proper fitting bear on whether the device helps the patient). So section 360k(a) expressly preempts both subsections, and the opinion did not need to reach the dormant-commerce-clause questions.

On the last question, the opinion explained that the Medical Device Amendments let a state ask the FDA for an exemption from preemption (for a more stringent requirement, or one justified by compelling local conditions that would not put the device out of federal compliance), with procedures in 21 C.F.R. section 808.20. Neither the statute nor the regulations set a cut-off date for applying, and a state's failure to apply earlier does not preclude applying later. The opinion cautioned that the FDA has not interpreted its own rule on any cut-off date, and any reasonable FDA interpretation would receive deference over an attorney general's opinion.

Currency note

This opinion was issued in 2007. Subsequent statutory amendments, court decisions, or later AG opinions may have changed the analysis. Treat this page as historical context, not current legal advice. Verify current law before relying on any specific rule, deadline, or remedy mentioned here.

The Occupations Code hearing-instrument provisions and the federal Food, Drug, and Cosmetic Act, the Medical Device Amendments, and FDA hearing-aid regulations have all been amended since 2007, including federal changes that created a category of over-the-counter hearing aids. Do not rely on this opinion for the current status of Texas or federal hearing-aid rules; check the current statutes and regulations.

Who this opinion affected (as of 2007)

The state hearing-instrument board and Texas regulators: The opinion told them the two Occupations Code provisions were preempted by federal law and therefore unenforceable as written, while pointing to the option of seeking an FDA exemption from preemption.

Hearing-aid sellers, including out-of-state mail-order companies: The opinion meant the Texas no-waiver exam requirement and the mail-order ban could not be enforced against them, because federal law occupied that ground and allowed both mail order and a waiver of the medical evaluation.

Consumers buying hearing aids: The opinion reflected the federal framework that let an informed adult waive the medical evaluation and permitted mail-order purchase, subject to the FDA's labeling and conditions of sale.

Common questions

Could Texas legally ban mail-order hearing aid sales in 2007?
No. The opinion concluded the ban in Occupations Code subsection 402.451(a)(7) was expressly preempted by the federal Medical Device Amendments, because the FDA had considered and rejected a mail-order ban.

Why was the mandatory audiological exam preempted?
The opinion explained the FDA rule lets an adult waive the medical evaluation, but the Texas rule required it with no waiver, making the state rule a requirement different from or in addition to the federal one, on a matter relating to the device's safety and effectiveness.

Did the Attorney General decide the commerce clause questions?
No. Because the provisions were preempted on federal-statute grounds, the opinion said it did not need to reach the dormant-commerce-clause constitutional questions.

Can Texas still ask the FDA to let it keep these rules?
The opinion said yes in principle: the Medical Device Amendments allow a state to seek an exemption from preemption, there is no cut-off date, and not asking before does not bar asking now, though the FDA has discretion and its own interpretation would get deference.

Background and statutory framework

The two state provisions appear in Occupations Code section 402.451, which lists prohibited acts for hearing-instrument fitters and dispensers. Subsection (a)(6) bars dispensing or fitting a hearing aid ordered by mail unless the dispenser is licensed, which through the definition of "fitting and dispensing hearing instruments" requires a licensed audiological evaluation; subsection (a)(7) bars selling a hearing aid by mail, defined as any sale not made in person by a licensee (Tex. Occ. Code Ann. §§ 402.451(a)(6)-(7), 402.001(4) (Vernon 2004); 22 Tex. Admin. Code § 141.2(15), (23) (2006)).

Courts resolve cases on nonconstitutional grounds when possible, so the opinion addressed preemption before the dormant commerce clause (In re B.L.D., 113 S.W.3d 340, 349 (Tex. 2003); U.S. Const. art. I, § 8, cl. 3). Under the Supremacy Clause, conflicting state law is without effect, and preemption may be express or implied, with congressional purpose the touchstone (U.S. Const. art. VI, cl. 2; Maryland v. Louisiana, 451 U.S. 725, 746 (1981); Am. Cyanamid Co. v. Geye, 79 S.W.3d 21, 23 (Tex. 2002); Cipollone v. Liggett Group, Inc., 505 U.S. 504, 516-17 (1992); Hillsborough County, Fla. v. Automated Med. Labs., Inc., 471 U.S. 707, 713 (1985)). The Medical Device Amendments contain an express preemption clause covering state device requirements that are different from or in addition to federal requirements and that relate to safety or effectiveness, and a hearing aid is a "device" under the Act (21 U.S.C.A. §§ 360, 360k(a), 360k(a)(2), 321(h) (West 1999); Medical Device Amendments of 1976, Pub. L. No. 94-295, 90 Stat. 539 (1976); Federal Pure Food and Drugs Act of 1906, Pub. L. No. 59-384, 34 Stat. 768 (1906); Medtronic, Inc. v. Lohr, 518 U.S. 470, 484 (1996); Smith v. Pingree, 651 F.2d 1021, 1023 (5th Cir. 1981)).

The FDA's hearing-aid rule requires a medical evaluation within six months before sale but allows an adult to waive it, and the FDA expressly declined to ban mail-order sales (21 C.F.R. §§ 801.420, 801.421, 801.421(a) (2006)). Both the no-waiver exam requirement and the mail-order ban differ from or add to those federal requirements and relate to safety and effectiveness, so both are preempted under section 360k(a). On exemptions, the Medical Device Amendments and FDA regulations let a state seek an exemption from preemption, with no cut-off date, and the FDA's interpretation of its own rule would receive deference (21 U.S.C.A. § 360k(b) (West 1999); 21 C.F.R. § 808.20 (2006); Christensen v. Harris County, 529 U.S. 576, 588 (2000)).

Citations

Constitution, statutes, and regulations:

• U.S. Const. art. I, § 8, cl. 3; art. VI, cl. 2
• 21 U.S.C.A. §§ 321(h), 360, 360k(a), 360k(a)(2), 360k(b) (West 1999)
• 21 C.F.R. §§ 801.420, 801.421, 801.421(a), 808.20 (2006)
• Medical Device Amendments of 1976, Pub. L. No. 94-295, 90 Stat. 539 (1976)
• Federal Pure Food and Drugs Act of 1906, Pub. L. No. 59-384, 34 Stat. 768 (1906)
• Tex. Occ. Code Ann. §§ 402.001(4), 402.451(a)(6)-(7) (Vernon 2004)
• 22 Tex. Admin. Code § 141.2(15), (23) (2006)

Cases:

• In re B.L.D., 113 S.W.3d 340, 349 (Tex. 2003)
• Maryland v. Louisiana, 451 U.S. 725, 746 (1981)
• Am. Cyanamid Co. v. Geye, 79 S.W.3d 21, 23 (Tex. 2002)
• Cipollone v. Liggett Group, Inc., 505 U.S. 504, 516 (1992)
• Hillsborough County, Fla. v. Automated Med. Labs., Inc., 471 U.S. 707, 713 (1985)
• Medtronic, Inc. v. Lohr, 518 U.S. 470, 484 (1996)
• Smith v. Pingree, 651 F.2d 1021, 1023 (5th Cir. 1981)
• Christensen v. Harris County, 529 U.S. 576, 588 (2000)

Source

• Landing page: https://www.texasattorneygeneral.gov/opinions/greg-abbott/ga-0525
• Original PDF: https://www.texasattorneygeneral.gov/sites/default/files/opinion-files/opinion/2007/ga0525.pdf

Original opinion text

Best-effort transcription from a scanned PDF. Minor errors may remain - the linked PDF is authoritative.

GREG ABBOTT

March 6, 2007

Mr. Ronald Ensweiler, President
State Committee of Examiners in the Fitting and Dispensing of Hearing Instruments
1100 West 49th Street
Austin, Texas 78756-3183

Opinion No. GA-0525

Re: Constitutionality of provisions of the Occupations Code, which prohibit the fitting 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, § 8, Cl. 3[.]

2. Whether Occupations Code § 402.451(a)(7) (1999), 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, § 8, Cl. 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?

4. Whether Occupations Code § 402.451(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. §§ 801.420 and 801.421 (2003)[,] pre-empts Occupations Code § 402.451(a)(6)[,] (7) (1999)[.]

7. Does the Federal Food, Drug and Cosmetic Act, 21 U.S.C.A. § 360 (1976) and 21 C.F.R. §§ 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. CODE ANN. § 402.451(a)(6)-(7) (Vernon 2004). Subsection 402.451(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 402] 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. ADMIN. 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 402.451(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. CODE ANN. § 402.451(a)(7) (Vernon 2004). The "selling of a hearing instrument by mail" means "[a]nytime a hearing instrument is not sold, fitted or dispensed in person by a licensee or permit holder." 22 TEX. ADMIN. 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 provisions but rather pertain to preemption issues concerning the two provisions, we will do likewise and consider them first.

You ask whether subsections 402.451(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, '[t]he 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, Fla. 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, Fla., 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. § 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.

21 U.S.C.A. § 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. §§ 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. § 321(h) (West 1999). Thus, we must consider the scope of the express exemption in section 360k(a) and determine whether subsections 402.451(a)(6) and (a)(7) fall within the scope of that preemption. See Medtronic, Inc. v. Lohr, 518 U.S. 470, 484 (1996) ("While the pre-emptive language of § 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); cf. Smith v. Pingree, 651 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)(1) of this section provided that the hearing aid dispenser [provides certain information and the specified waiver form].

21 C.F.R. § 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. CODE ANN. § 402.451(a)(6) (Vernon 2004). Under subsection 402.451(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. § 801.421 (2006). And as it did with the medical 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 402.451(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. § 360k(a)(2) (West 1999). With respect to the audiological examination required by subsection 402.451(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 402.451(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. CODE § 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. § 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

(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. § 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. § 360k(b) (West 1999); 21 C.F.R. § 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").

SUMMARY

Subsections 402.451(a)(6) and 402.451(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,

GREG ABBOTT
Attorney General of 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

Footnotes

[1] 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://www.oag.state.tx.us) [hereinafter Request Letter].