Can Texas require ephedrine dietary supplements to print the FDA's adverse-event reporting hotline on the label?

Plain-English summary

The Chairman of the Senate Committee on Administration asked whether the Texas Department of Health exceeded its authority by adopting a rule requiring certain dietary supplements sold in Texas to carry a label with the toll-free number of the FDA's MedWatch adverse-event reporting program. The rule applied to dietary supplements containing ephedrine, an alkaloid derived from the ephedra plant (ma huang). The Attorney General concluded the rule did not exceed the agency's statutory authority.

The opinion set the rule against the statutory framework. Dietary supplements are regulated as food, not drugs, under both federal and state law. After Congress passed the Dietary Supplement Health and Education Act in 1994, the FDA generally cannot approve most supplements before they reach the market and bears the burden of showing a marketed supplement is unsafe before restricting it. In Texas, the Department of Health regulates food and drug safety under Chapter 431 of the Health and Safety Code, the Texas Food, Drug, and Cosmetic Act. In 1999 the Legislature amended that Act to bar selling ephedrine products to people 17 or younger and to require labeling under department rules, and the department then adopted several rules on ephedrine supplements, including the MedWatch toll-free number requirement.

The standard the opinion applied was that an agency may adopt only rules authorized by and consistent with its statutory authority, and a rule may not impose burdens in excess of or inconsistent with the statute. Because Chapter 431 gives the department broad authority to protect public health and expressly contemplates state food labeling rules (defining "consumer commodity" to include food, prohibiting nonconforming labels, and treating food as misbranded if required information is not prominently placed), the opinion concluded the MedWatch label requirement fit within the department's authority and did not add anything inconsistent with the statute.

The opinion then addressed the specific objection in the request, that the rule improperly mandated use of a federal reporting system not designed for state use. It concluded the rule does not force anyone to use the federal system; it simply puts the program's number on the label so a consumer may choose to report. Based on a letter from the FDA, the MedWatch program is open to consumers, and the FDA welcomed the additional exposure and data. The opinion reasoned that a state rule publicizing a federal program open to the public, with the federal agency's consent, is not "commandeering" the program. Finally, the opinion found the department had a legitimate basis for treating the label as reasonably necessary to protect public health, pointing to the department's stated reasons and to more than 700 reported ephedrine adverse events since 1995, and distinguished a case (Christian Care Centers) where a rule was struck down as both unreasonable and inconsistent with its governing statute.

Currency note

This opinion was issued in 2001. Subsequent statutory amendments, court decisions, or later Attorney General 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. Federal regulation of ephedra and ephedrine alkaloid supplements changed significantly after this opinion (the FDA later moved to ban many such products), and both the Texas administrative rules and Chapter 431 have been amended since 2001, so the specific rule and citations described here may no longer be current.

What the opinion meant for those who asked

The Senate Committee on Administration (what the opinion held): The opinion concluded the Texas Department of Health did not exceed its statutory authority in requiring ephedrine dietary supplement labels to carry the FDA MedWatch toll-free number. The committee's concern, that the rule mandated use of a federal system not designed for state purposes, did not make the rule invalid, because the rule only publicized a consumer-accessible federal program with the FDA's consent.

The Texas Department of Health (what the opinion held for it): The opinion treated Chapter 431's broad grant of authority to regulate food and adopt food labeling rules as sufficient to support the MedWatch label requirement. It concluded the department had advanced a legitimate basis for the rule and that a court would likely uphold it.

Dietary supplement manufacturers and sellers (what the opinion held for them): The opinion treated the labeling requirement as a valid exercise of the department's authority, so a supplier of ephedrine-containing dietary supplements in Texas was subject to the rule requiring the MedWatch number on the product label.

Common questions

Could Texas legally require the FDA hotline on supplement labels?
The opinion concluded yes. Chapter 431 of the Health and Safety Code gives the Texas Department of Health broad authority to regulate food, which includes dietary supplements, and to set food labeling rules, so the MedWatch label requirement was authorized by and consistent with the statute.

Doesn't putting a federal number on the label "commandeer" the FDA?
The opinion concluded no. The rule does not force use of the federal system; it provides the number so a consumer may choose to report an adverse event. The MedWatch line is open to consumers, and the FDA said it welcomed the added reporting, so the opinion found no improper commandeering or dictating of the federal program.

What is the test for whether an agency rule is within its authority?
The opinion explained that an agency can adopt only rules authorized by and consistent with its statutory authority, and the key question is whether the rule harmonizes with the statute's general objectives. A rule may not impose burdens in excess of or inconsistent with the statute, but courts will uphold a reasonable rule based on a legitimate position of the agency.

Why did the rule single out ephedrine products?
The opinion pointed to the department's stated reasons: there were no established safe-dosing standards, products varied, and a single reporting point would help identify products causing adverse events. The department also noted more than 700 ephedrine-related adverse events reported since 1995. The opinion concluded that was a legitimate basis for the rule.

Background and statutory framework

At the federal level, food and drug safety is regulated by the FDA under the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. §§ 301-397 (1994 & Supp. V 1999). Congress has not foreclosed state regulation of food and drug safety, which is a field traditionally occupied jointly by the states and the federal government. Kellogg Co. v. Mattox, 763 F. Supp. 1369, 1379 (N.D. Tex. 1991). In 1994, Congress enacted the Dietary Supplement Health and Education Act, Pub. L. No. 103-417, 108 Stat. 4325 (1994), which removed the FDA's authority to approve most dietary supplements before marketing and placed on the FDA the burden of showing a marketed supplement is unsafe before restricting it. See 21 U.S.C. §§ 321, 343 (1994 & Supp. V 1999); id. § 342(f) (1994).

Within Texas, the Department of Health regulates food and drug safety under the Texas Food, Drug, and Cosmetic Act, Chapter 431 of the Health and Safety Code. Tex. Health & Safety Code Ann. ch. 431 (Vernon 2001). In 1999, citing concerns about misuse of ephedrine products, the Legislature amended the Act to prohibit sale of ephedrine products to persons 17 or younger and to require labeling under department rules. Id. § 431.022. The department then adopted rules on ephedrine supplements, 25 Tex. Admin. Code §§ 229.461, .462, .463, .464 (2001), including the requirement that the label include the FDA MedWatch toll-free number, id. § 229.462(f).

The opinion applied the rule that an agency can adopt only rules authorized by and consistent with its statutory authority, and that the critical factor is whether the rule harmonizes with the general objectives of the statute. R.R. Comm'n v. Arco Oil & Gas Co., 876 S.W.2d 473, 481 (Tex. App.-Austin 1994, writ denied); Edgewood Indep. 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). The department and the Board of Health are established to protect and promote public health, Tex. Health & Safety Code Ann. § 11.002 (Vernon 2001), with general supervision and rule-making authority, id. § 12.001(a), (b)(1). Chapter 431 expressly authorizes the department to enact rules for the efficient enforcement of the chapter, id. § 431.241(a), and contemplates state food labeling rules: it prohibits distribution of a consumer commodity with a nonconforming label, id. § 431.021(d), defines consumer commodity to include food, id. § 431.002(8), and treats food as misbranded if required information is not prominently placed on the label, id. § 431.082(g).

On the implied-authority and reasonableness question, the opinion drew on Texas Department of Human Services v. Christian Care Centers, 826 S.W.2d 715, 719 (Tex. App.-Austin 1992, writ denied), which recognized that an agency has the implied authority reasonably necessary to accomplish a delegated purpose, while also noting that courts uphold reasonable rules based on a legitimate agency position. Bullock v. Hewlett-Packard Co., 628 S.W.2d 754, 756 (Tex. 1982); Graves v. Morales, 923 S.W.2d 754, 757 (Tex. App.-Austin 1996, writ denied); 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 rule struck down in Christian Care Centers was both unreasonable and inconsistent with its governing statute; the opinion found the MedWatch label rule different on both counts.

Citations

Statutory and regulatory provisions:

• 25 Tex. Admin. Code § 229.462(f) (2001)
• 25 Tex. Admin. Code §§ 229.461, .462, .463, .464 (2001)
• 21 U.S.C. §§ 301-397 (1994 & Supp. V 1999)
• 21 U.S.C. §§ 321, 343 (1994 & Supp. V 1999)
• Dietary Supplement Health and Education Act, Pub. L. No. 103-417, 108 Stat. 4325 (1994)
• Tex. Health & Safety Code Ann. ch. 431 (Vernon 2001)
• Tex. Health & Safety Code Ann. § 431.022 (Vernon 2001)
• Tex. Health & Safety Code Ann. § 431.241(a) (Vernon 2001)
• Tex. Health & Safety Code Ann. § 431.021(d) (Vernon 2001)
• Tex. Health & Safety Code Ann. § 431.002(8) (Vernon 2001)
• Tex. Health & Safety Code Ann. § 431.082(g) (Vernon 2001)
• Tex. Health & Safety Code Ann. § 11.002 (Vernon 2001)
• Tex. Health & Safety Code Ann. § 12.001(a), (b)(1) (Vernon 2001)

Cases:

• Kellogg Co. v. Mattox, 763 F. Supp. 1369 (N.D. Tex. 1991)
• R.R. Comm'n v. Arco Oil & Gas Co., 876 S.W.2d 473 (Tex. App.-Austin 1994, writ denied)
• Edgewood Indep. Sch. Dist. v. Meno, 917 S.W.2d 717 (Tex. 1995)
• R.R. Comm'n v. Lone Star Gas Co., 844 S.W.2d 679 (Tex. 1992)
• Texas Department of Human Services v. Christian Care Centers, 826 S.W.2d 715 (Tex. App.-Austin 1992, writ denied)
• Bullock v. Hewlett-Packard Co., 628 S.W.2d 754 (Tex. 1982)
• Graves v. Morales, 923 S.W.2d 754 (Tex. App.-Austin 1996, writ denied)
• Chrysler Motors Corp. v. Tex. Motor Vehicle Comm'n, 846 S.W.2d 139 (Tex. App.-Austin 1993, no writ)
• McCarty v. Tex. Parks & Wildlife Dep't, 919 S.W.2d 853 (Tex. App.-Austin 1996, no writ)

Source

• Landing page: https://www.texasattorneygeneral.gov/opinions/john-cornyn/jc-0445
• Original PDF: https://www.texasattorneygeneral.gov/sites/default/files/opinion-files/opinion/2001/jc0445.pdf

Original opinion text

Best-effort transcription from the official scanned PDF. Minor character-level errors from the source OCR have been corrected; the linked PDF is authoritative.

OFFICE OF THE ATTORNEY GENERAL - STATE OF TEXAS

JOHN CORNYN

December 20, 2001

The Honorable David Cain
Chairman
Senate Committee on Administration
Texas State Senate
P.O. Box 12068
Austin, Texas 78711

Opinion No. JC-0445

Re: Whether the Texas Department of Health 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 toll-free telephone number for reporting adverse events (RQ-0414-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?[1]

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 § 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. §§ 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 (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 & Safety Code Ann. ch. 431 (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's Medical Dictionary 581, 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. §§ 321, 343 (1993) (prior to 1994 amendments), with 21 U.S.C. §§ 321, 343 (1994 & Supp. V 1999). In 1994, Congress enacted the Dietary Supplement Health and Education Act ("DSHEA"), Pub. L. No. 103-417, 108 Stat. 4325 (1994) (codified throughout 21 U.S.C.), to increase the public's access to dietary supplements. See generally DSHEA, § 2, 21 U.S.C. § 321 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. § 321(g)(1) (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. §§ 331(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. § 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.gov/~dms/ds-oview.html.

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 & Safety Code Ann. § 431.022 (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. § 431.022(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. § 229.462(h).

Section 229.462 also contains the labeling requirement at issue in your request in subsection (f):

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 1-800-332-1088, which is the Food and Drug Administration's MedWatch medical product reporting program.

Id. § 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. 6514, 6515 (2000) (codified as an amendment to 25 Tex. Admin. Code § 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 of the statute involved. See Edgewood Indep. 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 481. 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 & Safety Code Ann. § 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. § 12.001(a), and is vested with general rule-making authority, see id. § 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 431 expressly authorizes TDH to enact rules "for the efficient enforcement of this chapter," id. § 431.241(a), and provides that a violation of a rule adopted under chapter 431 "is a violation of this chapter," id. § 431.046. 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. §§ 431.241(b), (c), (d), .244, .245.

TDH regulates dietary supplements, such as those containing ephedrine, as food.[3] Provisions of chapter 431 clearly contemplate that TDH may promulgate state food labeling rules under the chapter. For example, section 431.021 expressly prohibits "the distribution in commerce of a consumer commodity, if such commodity is contained in a package, or if there is affixed to that commodity a label that does not conform to the provisions of this chapter and of rules adopted under the authority of this chapter." Id. § 431.021(d) (emphasis added). The term "consumer commodity" as used in chapter 431 expressly includes foods. See id. § 431.002(8) (defining "consumer commodity" to include "any food, drug, device, or cosmetic"). Another provision, section 431.082, 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. § 431.082(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 that the rule is problematic because it attempts to "commandeer" a federal system of reporting,[4] or "dictate" the operation of the system.[5]

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 process,[6] 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 Cornyn, 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-rept.html ("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 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 431 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." Bullock v. 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 431 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 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. 6514 (2000). In response to the comments that it could not justify singling out dietary supplements products containing ephedrine for special treatment, TDH explained that

[s]ince 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 6514. 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 6515. 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 431 of the Health and Safety Code.

[1] Letter from Honorable David Cain, Chair, Senate Committee on Administration, Texas State Senate, to Honorable John Cornyn, Texas Attorney General (Aug. 14, 2001) (on file with Opinion Committee) [hereinafter Request Letter].

[2] Senate Comm. on Health Services, Bill Analysis, Tex. S.B. 656, 76th Leg., R.S. (1999).

[3] Brief from Susan K. Steeg, General Counsel, Texas Department of Health, to Susan D. Gusky, Chair, Opinion Committee at 4 (Oct. 4, 2001) (on file with Opinion Committee).

[4] Letter from Nancy A. Bukar, Director of State Government Relations, Consumer Healthcare Products Association, to Susan D. Gusky, Chair, Opinion Committee at 4 (Oct. 10, 2001) (on file with Opinion Committee).

[5] 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 Brief].

[6] See, 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-187 (1968) at 3 ("[T]his office is without authority to make . . . factual determinations."); O-2911 (1940) at 2 ("[T]his . . . presents a fact question which we are unable to answer.").

                                   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.

                                          Very truly yours,

                                          JOHN CORNYN
                                          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