   OFFICE   OF THE   ATTORNEY   GENERAL   . STATE    OF   TEXAS

   JOHN     CORNYN




                                                    December 20,200l



The Honorable David Cain                                          Opinion No. JC-0445
Chairman
Senate Committee on Administration                            Re: Whether the Texas Department of Health has
Texas State Senate                                            exceeded its authority in adopting a rule requiring
P.O. Box 12068                                                certain dietary supplements sold in Texas to bear a
Austin, Texas 78711                                           label with a United States Food and Drug
                                                              Administration    toll-free telephone number for
                                                              reporting adverse events (RQ-04 14-JC)


Dear Senator Cain:

        You ask whether the Texas Department of Health (“TDH”) has exceeded its authority in
adopting a rule requiring certain dietary supplements sold in Texas to bear a label with a United
States Food and Drug Administration (“FDA”) toll-free telephone number for reporting adverse
events. Specifically, in your letter to this office, you pose the following question:

                 Does the Texas Department of Health exceed its statutory and
                 regulatory authority in mandating the use of a federal reporting
                 system, which system was not operationally designed or intended by
                 [the] United States Congress or the Texas Legislature for use by or
                 for state agencies, state purposes or state consumers?’

The rule you are concerned about requires the product labels of dietary supplements containing
ephedrine to include the toll-free number of the FDA’s MedWatch medical product reporting
program. See 25 TEX. ADMIN. CODE 0 229.462(f) (2001). For the reasons explained below, we
conclude that the rule does not exceed the agency’s statutory authority.

          We begin with a brief review of the statutory framework. At the federal level, the safety of
 food and drugs is regulated by the FDA under the Federal Food, Drug, and Cosmetic Act, 21 U.S.C.
 4 8 301-397 (1994 & Supp. V 1999). Congress has not entirely foreclosed state regulation of food and
drug safety: “Regulation of the sale and labelling of food and drugs is a field traditionally occupied
jointly by the states and the federal government.” Kellogg Co. v. Mattox, 763 F. Supp. 1369, 1379



         ‘Letter from Honorable David Cain, Chair, Senate Committee on Administration,       Texas State Senate, to
Honorable John Comyn, Texas Attorney General (Aug. 14, 2001) (on file with Opinion          Committee) [hereinafter
Request Letter].
The Honorable David Cain - Page 2              (JC-0445)




(N.D. Tex. 1991). Within the State of Texas, TDH regulates food and drug safety under the Texas
Food, Drug, and Cosmetic Act, TEX. HEALTH& SAFETYCODEANN. ch. 43 1 (Vernon 2001).

         The rule at issue governs dietary supplements containing ephedrine, an alkaloid derived from
the ephedra plant, also known as ma huang. See STEDMAN’SMEDICALDICTIONARY58 1,1054 (26th
ed. 1995) (defining “ephedrine,” “ma huang”). Dietary supplements are regulated as food under
federal and state law rather than as drugs. Under federal law prior to 1994, in order to make claims
regarding a dietary supplement’s health benefits, the manufacturer had to obtain pre-market approval
from the FDA by showing that the product was safe and effective. Compare 21 U.S.C. $5 321,343
(1993) (prior to 1994 amendments), with 21 U.S.C. $5 321,343 (1994 & Supp. V 1999). In 1994,
Congress enacted the Dietary Supplement Health and Education Act (“DSHEA”), 103 Pub. L. No.
417,108 Stat. 4325 (1994) (codified throughout 21 U.S.C.), to increase the public’s access to dietary
supplements.     See generally DSHEA, 9 2, 21 U.S.C. 8 32 1 note (1994) (Congressional Findings
Relating to Pub. L. 103-417). The new law stripped the FDA of its authority to approve most dietary
supplements before they are marketed.        See 21 U.S.C. 9 321(g)(l) (1994) (exempting “dietary
supplement” from definition of “drug”), (s)(6) (1994) ( exempting “dietary supplement” from
definition of “food additive”), (ff) (1994 & Supp. V 1999) (defining “dietary supplement”); id. $6
33 1(u) (1994); 342(f), (g) (1994); 343(r) (1994 & Supp. V 1999) (health claims regarding dietary
supplements); 343(s) (1994); 343-2 (1994) (dietary supplement labeling exemptions); 350b (1994)
(exception for dietary supplements containing new dietary ingredients). Furthermore, under the new
law, once a product is marketed, the FDA has the burden of proving that a dietary supplement is
unsafe before it can take action to restrict the product’s use or to remove the product from the
marketplace, see 21 U.S.C. 4 342(f) (1994). As the FDA has explained,

               Under DSHEA, a firm is responsible for determining that the dietary
               supplements it manufactures or distributes are safe and that any
               representations   or claims made about them are substantiated by
               adequate evidence to show that they are not false or misleading. This
               means that dietary supplements do not need approval from FDA
               before they are marketed.       Except in the case of a new dietary
               ingredient, where pre-market review for safety data and other
               information is required by law, a firm does not have to provide FDA
               with the evidence it relies on to substantiate safety or effectiveness
               before or after it markets its products. . . .

               Under DSHEA, once the product is marketed, FDA has the
               responsibility   for showing that a dietary supplement is “unsafe,”
               before it can take action to restrict the product’s use or removal from
               the marketplace.

CTR. FOR FOOD SAFETY AND APPLIED NUTRITION,U.S. FOOD & DRUG ADMIN., OVERVIEW OF
DIETARY SUPPLEMENTS(2001), available at www.cfsan.fda.nov/-dmslds-oview.html.
The Honorable   David Cain - Page 3             (JC-0445)




        In 1999, citing concerns regarding “the misuse of certain products containing ephedrine and
marketed as stimulants, appetite suppressants, and muscle enhancers,“2 the Texas Legislature
amended the Texas Food, Drug and Cosmetic Act to prohibit the sale of products containing
ephedrine to persons 17 years of age or younger. See TEX.HEALTH& SAFETYCODEANN. 8 43 1.022
(Vernon 2001). This statute also requires that products containing ephedrine “must be labeled in
accordance with rules adopted by the Texas Department of Health to indicate that sale to persons 17
years of age or younger is prohibited.” Id. 8 43 1.022(c). In 1999 and 2000, TDH promulgated
several rules regulating dietary supplements containing ephedrine. See 25 TEX. ADMIN. CODE §§
229.461, .462, .463, .464 (2001). Section 229.462 of title 25 of the Texas Administrative Code
contains various labeling requirements for dietary supplements containing ephedrine, including a
warning statement that indicates the sale to persons 17 years of age or younger is prohibited. See id.
5 229.462(h).                                                                                              .

        Section 229.462 also contains the labeling requirement    at issue in your request in subsection



                         After September 1, 2001, the product label must include a
                toll-free number to permit consumers to report adverse effects. This
                toll-free number shall be l-800-332-1 088, which is the Food and Drug
                Administration’s MedWatch medical product reporting program.

Id. 5 229.462(f). Subsection (f) was adopted in July 2000, but TDH delayed its effective date until
September 1,2001, to give manufacturers time to comply. See 25 Tex. Reg. 673 (2000), adopted
25 Tex. REG. 65 14,65 15 (2000) (codified as an amendment to 25 TEX. ADMIN. CODE 8 229.462).

         Again, you ask whether TDH has exceeded its authority in adopting this rule. In reviewing
the rule, we are guided by the maxim that “[a]n agency can adopt only such rules as are authorized
by and consistent with its statutory authority.” R.R. Comm ‘n v. Arco Oil & Gas Co., 876 S.W.2d 473,
481 (Tex. App.-Austin       1994, writ denied).     The critical factor in determining whether an
administrative agency has exceeded its rule-making authority is whether the rule’s provisions are in
harmony with the general objectives ofthe statute involved. See Edgewoodlndep. Sch. Dist. v. Meno,
917 S.W.2d 717,750 (Tex. 1995); R.R. Comm ‘n v. Lone Star Gas Co., 844 S.W.2d 679,685 (Tex.
 1992). An agency rule may not impose additional burdens, conditions, or restrictions in excess of or
inconsistent with the relevant statutory provisions. See R.R. Comm ‘n, 876 S.W.2d at 48 1. Applying
this standard, we conclude that the TDH rule does not exceed the agency’s statutory authority.

         TDH and the Texas Board of Health, its governing body, “are established to better protect and
promote the health of the people of this state.” TEX.HEALTH& SAFETYCODEANN. 5 11.002 (Vernon
2001). The board “has general supervision and control over all matters relating to the health of the
citizens of this state,” id. 8 12.001(a), and is vested with general rule-making authority, see id. 0




       *SENATE COMM. ON HEALTH SERVICES, BILL ANALYSIS, Tex. S.B. 656,76th   Leg., R.S. (1999).
The Honorable David Cain - Page 4                     (JC-0445)




12.001 (b)( 1) (the board shall “adopt rules . . . for the performance         of each duty imposed by law on
the board, the department”).

         The Texas Food, Drug, and Cosmetic Act, chapter 431 of the Health and Safety Code,
provides for extensive state regulation of foods and drugs by the Texas Department of Health.
Chapter 43 1 expressly authorizes TDH to enact rules “for the efficient enforcement of this chapter,”
id. 5 43 1.24 1(a), and provides that a violation of a rule adopted under chapter 43 1 “is a violation of
this chapter,” id. 8 43 1.046. The chapter expressly references and incorporates certain provisions of
the Federal Food, Drug and Cosmetic Act and federal rules adopted under that Act and, in addition,
grants TDH the general authority to conform its rules with federal rules and to adopt, reject, or modify
others, see, e.g., id. $0 431.241(b), (c), (d), .244, .245.

        TDH regulates dietary supplements, such as those containing ephedrine, as food.3 Provisions
of chapter 43 1 clearly contemplate that TDH may promulgate state food labeling rules under the
chapter. For example, section 43 1.021 expressly prohibits “the distribution in commerce of a
consumer commodity, if such commodity is contained in a package, or if there is afjxed to that
commodity a label that does not conform to the provisions of this chapter and of rules adopted under
the authority ofthis chapter.” Id. 8 43 1.02 1(d) (emphasis added). The term “consumer commodity”
as used in chapter 431 expressly includes foods. See id. 0 431.002(8) (defining “consumer
commodity” to include “any food, drug, device, or cosmetic”). Another provision, section 43 1.082,
provides that food shall be deemed misbranded if “any word, statement, or other information
required by or under the authority of this chapter to appear on the label or labeling is not
prominently placed thereon with such conspicuousness . . . and in such terms as to render it likely to
be read and understood by the ordinary individual under customary conditions of purchase and use.”
Id. 8 43 1.082(g) (emphasis added).

        Given TDH’s general authority to protect public health and, moreover, that chapter 431
expressly contemplates state food labeling rules, we conclude that the TDH rule requiring dietary
supplements containing ephedrine to bear a label with a telephone number for reporting adverse
events is authorized by and consistent with TDH’s statutory authority. Furthermore, given that
chapter 431 contemplates state food labeling rules, the rule cannot be said to impose additional
burdens, conditions, or restrictions in excess of or inconsistent with the relevant statutory provisions.

         The argument has been made that this particular labeling requirement exceeds TDH’s
authority because, as your query suggests, it “mandat[es] the use of a federal reporting system,” the
FDA MedWatch program, which your query asserts “was not operationally designed or intended by
[the] United States Congress or the Texas Legislature for use by or for state agencies, state purposes
or state consumers.” Request Letter, supra note 1, at 1. Other comments we have received suggest




         3Brief from Susan K. Steeg, General Counsel, Texas Department   of Health, to Susan D. Gusky, Chair, Opinion
Committee at 4 (Oct. 4,200l) (on file with Opinion Committee).
The Honorable David Cain - Page 5                         (JC-0445)




 that the rule is problematic because it attempts to “commandeer”                 a federal system of reporting,4 or
,“dictate” the operation of the system?

         The required label does not mandate use of the federal reporting system but rather requires
that the program’s toll-free number be provided to consumers on product labels. Consumers have
the choice to report a suspected adverse event to the FDA at this number. Although this office does
not find facts in the opinion proces$j information we have received from the FDA indicates that the
MedWatch program is intended for use by the general public and the TDH rule is consistent with the
goals of the MedWatch program. First, we have received a letter from the FDA indicating that the
MedWatch program is intended for both medical professionals and consumers to use to report adverse
events. See Letter from Bernard A. Schwetz, D.V.M., Ph.D., Acting Principal Deputy Commissioner,
United States Food and Drug Administration, to Honorable John Comyn, Texas Attorney General
(Oct. 5, 2001) (on file with Opinion Committee) [hereinafter FDA Letter] (“The FDA MedWatch
system is intended to collect information related to adverse events associated with FDA regulated
products. While the system was originally designed to accept reports from healthcare professionals,
it has since been expanded to accept calls from consumers and other interested parties.“). The FDA’s
website also states that consumers may report adverse events relating to dietary supplements to the
FDA by calling the MedWatch number. See www.cfsan.fda. gov/dms/ds-repthtml           (“Consumers may
also report an adverse event or illness they believe to be related to use of a dietary supplement by
calling FDA at 1-800-FDA-1088.“).       Furthermore, the FDA letter indicates that the federal agency
welcomes the exposure it would receive as a result of the TDH labeling requirement. See FDA Letter,
supra (“TDH consulted with us on several occasions, during the Rule 229.462 development and
subsequent to its adoption, concerning the capabilities of the MedWatch system and our interest in
receiving this data. We advised TDH that we encourage the reporting of adverse events by consumers
and other interested parties, that the MedWatch System has the capacity to handle these reports, and
that Rule 229.462 could assist us in capturing valuable data associated with ephedra alkaloid adverse
events.“).

         Based on the FDA’s assertions, we see no basis for concluding that the TDH rule exceeds
TDH’s authority because the MedWatch number is not intended for consumers. Furthermore, we do
not believe that a state rule that provides publicity for a federal program open to the general public
with the consent of the federal agency may be fairly characterized as commandeering the program
or dictating its operation. Finally, we do not believe that the Texas Legislature must expressly



          4Letter from Nancy A. Bukar, Director of State Government Relations, Consumer Heal&are       Products
Association, to Susan D. Gusky, Chair, Opinion Committee at 4 (Oct. 10,200l) (on file with Opinion Committee).

         ‘Letter Brief from A. Wes Siegner, Jr., Hyman, Phelps & McNamara, P.C., to Susan D. Gusky, Chair, Opinion
Committee (Oct. 5, 2001) (submitted on behalf of American Herbal Products Association) (on file with Opinion
Committee) [hereinafter AHPA BriefJ.

          6See, e.g., Tex. Att’y Gen. Op. Nos. JC-0020 (1999) at 2 (stating that investigation      and resolution of fact
questions cannot be done in opinion process); M-l 87 (1968) at 3 (“[Tlhis office is without authority to make . . . factual
determinations.“);   O-291 1 (1940) at 2 (“[Tlhis . . . presents a fact question which we are unable to answer.“).
The Honorable David Cain - Page 6               (JC-0445)




authorize a state agency to adopt a rule that may increase use of a federal program that is available
to the general public; TDH’s authority to impose labeling requirements under chapter 43 1 of the
Health and Safety Code is sufficient.

         We have also been urged to conclude that the labeling requirement exceeds TDH’s statutory
authority because it is not “reasonably necessary,” in a brief relying on Texas Department of Human
Services v. Christian Care Centers, 826 S.W.2d 715 (Tex. App.-Austin 1992, writ denied). See
AHPA Brief, supra note 5, at 40. The court in that case observed that

               [l]ack of express authority for a particular act of an agency does not
               mean the agency has no authority for that act. An agency may have
               implied authority to take an action or promulgate a rule even though
               such authority might not be expressly enumerated in its enabling
               statute. Indeed, under a general grant of authority, an agency has all
               the implied authority reasonably necessary to accomplish a delegated
               purpose.

 Christian Care Ctrs., 826 S.W.2d at 719 (emphasis added). Although Texas courts in some cases
have required a state agency rule that is not expressly authorized by the legislature to be “reasonably
necessary” to achieve an expressly delegated purpose, courts are also loath to substitute their
judgment for the judgment of the agency. As the Texas Supreme Court has stated, courts must
uphold administrative rules if they are reasonable: “The rules need not be, in the court’s opinion,
wise, desirable, or even necessary. Such rules need only be based on some legitimate position by the
administrative agency involved.” Bullockv. Hewlett-Packard Co., 628 S. W.2d 754,756 (Tex. 1982)
(citations omitted); see also Graves v. Morales, 923 S.W.2d 754,757 (Tex. App.-Austin 1996, writ
denied) (citing Bullock v. Hewlett-Packard Co., 628 S.W.2d at 756; Chrysler Motors Corp. v. Tex.
Motor Vehicle Comm ‘n, 846 S.W.2d 139, 142 (Tex. App.-Austin 1993, no writ)); McCarty v. Tex.
Parks & Wildlife Dep’t, 919 S.W.2d 853, 854 (Tex. App.-Austin           1996, no writ). The court in
Christian Care Centers invalidated the rule at issue in that case because it determined not only that
the rule was “not reasonable in light of the circumstances present” but also that the rule was
inconsistent with the overall purpose of the governing statutes. See Christian Care Centers, 826
S.W.2d at 721.

        The record suggests that TDH had a legitimate basis for determining that the labeling
requirement at issue was reasonably necessary to further the agency’s express duty under chapter 43 1
of the Health and Safety Code to protect public health. In adopting the labeling requirement, TDH
stated:

               The purpose of this section is to allow consumers to report adverse
               events associated with the use of ephedrine-containing       dietary
               supplements.   Adverse events monitoring systems, such as the FDA
               MedWatch program, are designed to identify unanticipated           or
               unintended safety problems with use of marketed products. Patterns
The Honorable   David Cain - Page 7              (JC-0445)




                of adverse events help the FDA identify the need for further
                investigation to determine whether public health actions are needed.
                The information will be collected by the FDA and will be available for
                review to all interested parties.

25 Tex. Reg. 65 14 (2000). In response to the comments that it could not justify singling out dietary
supplements products containing ephedrine for special treatment, TDH explained that

                [slince there are no established and recognized requirements relative
                to safe dosing intake or ingredient level, there is a strong likelihood of
                a lack of any uniformity among different products. Products suspected
                of causing adverse events can be more expeditiously identified if the
                consumer has access to a single point for reporting adverse events
                associated with product consumption.

Id. at 65 14. TDH also observed that

                [a]mple justification has been provided to the department for the need
                for a toll free number for consumers to report adverse events. Neither
                the department, nor any other agency, currently has access to all
                complaints reported concerning dietary supplements.         Collection of
                this information by an agency subject to freedom of information
                review will allow all interested parties to review the data. Since 1995,
                over 700 adverse events associated with the consumption of ephedrine
                have been reported to the department since the passage of the Dietary
                Supplement Health and Education Act.

Id. at 65 15. We conclude that TDH has advanced a legitimate basis for adopting the rule; we believe
a court would reach the same conclusion. Moreover, in contrast to the rule at issue in Christian Care
Centers, the TDH labeling rule is consistent with the purposes of chapter 43 1 of the Health and Safety
Code.
The Honorable   David Cain - Page 8               (JC-0445)




                                        SUMMARY

                         The Texas Department     of Health did not exceed its statutory
                authority in promulgating     a    rule requiring dietary supplements
                containing ephedrine to bear a    label with the United States Food and
                Drug Administration MedWatch        program’s toll-free telephone number
                for reporting adverse events.




                                              Attorney General of Texas



HOWARD G. BALDWIN, JR.
First Assistant Attorney General

NANCY FULLER
Deputy Attorney General - General Counsel

SUSAN D. GUSKY
Chair, Opinion Committee

Mary R. Crouter
Assistant Attorney General, Opinion Committee
