OFFICE OF THE ATTORNEY GENERAL

. STATE OF TEXAS JOHN CORNYN

December 20,200l

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-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 orintended 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 abrief review ofthe statutory framework. At the federal level, the safety of food and drugs isregulated by the FDA under the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 48301-397 (1994 & Supp. V 1999). Congress has not entirely foreclosed state regulation offood and drug safety: “Regulation ofthe sale and labelling offood and drugs is afield 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& SAFETY CODEANN.ch. 431(Vernon 2001).
The rule atissue governs dietary supplements containing ephedrine, an alkaloid derived from the ephedra plant, also known asma huang. See STEDMAN’S MEDICAL

DICTIONARY581,1054 (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 adietary 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 21U.S.C.), toincrease the public’s access to dietary supplements. See generally DSHEA, 9 2, 21 U.S.C. 8 321note (1994) (Congressional Findings Relating toPub. L. 103-417). The new law stripped the FDA ofits 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. $6 331(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 aproduct 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. 4342(f) (1994). As the FDA has explained,

Under DSHEA, afirm isresponsible 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 ormisleading. 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, afirm does not have to provide FDA with the evidence it relies on to substantiate safety or effectiveness before or after itmarkets 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 orremoval from the marketplace.
CTR.FORFOOD SAFETYAND APPLIEDNUTRITION,U.S. FOOD& DRUG ADMIN., OVERVIEWOF DIETARYSUPPLEMENTS (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 ofcertain 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 17years of age oryounger. See TEX.HEALTH & SAFETY

CODEANN. 8431.022 (Vernon 2001). This statute also requires that products containing ephedrine “must be labeled in accordance with rules adopted by the Texas Department ofHealth to indicate that sale to persons 17 years of age or younger is prohibited.” Id. 8 431.022(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 17years of age oryounger isprohibited. See id. 5229.462(h).

. Section 229.462 also contains the labeling requirement atissue 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 isthe Food and Drug Administration’s MedWatch medical product reporting program.
Id. 5229.462(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. 6514,65 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 ‘nv.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 iswhether the rule’s provisions are in harmony with the general objectives ofthe statute involved. SeeEdgewoodlndep. Sch. Dist. v.Meno, 917 S.W.2d 717,750 (Tex. 1995); R.R. Comm ‘nv.Lone Star Gas Co., 844 S.W.2d 679,685 (Tex. 1992). An agency rule may not impose additional burdens, conditions, orrestrictions in excess ofor inconsistent with the relevant statutory provisions. SeeR.R. Comm ‘n,876 S.W.2d at48 1. Applying this standard, we conclude that the TDH rule does not exceed the agency’s statutory authority.
TDH and the Texas Board ofHealth, its governing body, “are established tobetter protect and promote the health ofthe people ofthis state.” TEX.HEALTH & SAFETY

CODE ANN.5 11.002 (Vernon 2001). The board “has general supervision and control over all matters relating to the health ofthe citizens of this state,” id. 8 12.001(a), and is vested with general rule-making authority, see id. 0

*SENATECOMM. ON HEALTH SERVICES,BILLANALYSIS,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 431expressly authorizes TDH to enact rules “for the efficient enforcement ofthis chapter,” id. 5431.24 1(a), and provides that aviolation of arule adopted under chapter 431“is aviolation of this chapter,” id. 8431.046. 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 toconform itsrules with federal rules and to adopt, reject, ormodify others, see, e.g., id. $0 431.241(b), (c), (d), .244, .245.
TDH regulates dietary supplements, such asthose containing ephedrine, asfood.3 Provisions of chapter 43 1clearly 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 afjxed to that commodity alabel that does not conform to the provisions ofthis chapter and ofrules adopted under the authority ofthis chapter.” Id. 8431.021(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 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 asto render it likely to be read and understood by the ordinary individual under customary conditions ofpurchase and use.” Id. 8431.082(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, orrestrictions in excess oforinconsistent 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 afederal reporting system,” the FDA MedWatch program, which your query asserts “was not operationally designed orintended by [the] United States Congress orthe Texas Legislature foruse 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 ofHealth, 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 ofreporting,4 or ,“dictate” the operation ofthe system?
The required label does not mandate use ofthe 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 atthis 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 foruse by the general public and the TDH rule isconsistent with the goals of the MedWatch program. First, we have received aletter from the FDA indicating that the MedWatch program isintended forboth medical professionals and consumers touse toreport 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, ithas 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. Seewww.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 itwould receive asaresult ofthe 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 ofthe MedWatch system and our interest in receiving this data. We advised TDH that we encourage the reporting ofadverse 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 isnot intended for consumers. Furthermore, we do not believe that a state rule that provides publicity for afederal 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 iswithout authority tomake

...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 arule that may increase use of afederal 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 itisnot “reasonably necessary,” in abrief relying on Texas Department 

### ofHuman 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 aparticular 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 arule even though such authority might not be expressly enumerated in its enabling statute. Indeed, under ageneral grant of authority, an agency has all the implied authority reasonably necessary to accomplish adelegated purpose.
Christian Care Ctrs., 826 S.W.2d at 719 (emphasis added). Although Texas courts in some cases have required astate agency rule that isnot expressly authorized by the legislature tobe “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 bebased 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 atissue 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 atissue was reasonably necessary to further the agency’s express duty under chapter 431 ofthe 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. PatternsThe 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. 6514(2000). In response to the comments that it could notjustify 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 oringredient level, there is astrong likelihood of alack ofany uniformity among different products. Products suspected of causing adverse events can be more expeditiously identified ifthe
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 atoll 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 allinterested parties toreview the data. Since 1995, over 700 adverse events associated with the consumption ofephedrine have been reported to the department since the passage ofthe Dietary Supplement Health and Education Act.
Id. at 6515. We conclude that TDH has advanced alegitimate basis for adopting the rule; we believe acourt would reach the same conclusion. Moreover, incontrast tothe rule atissue in Christian Care Centers, the TDH labeling rule isconsistent with the purposes ofchapter 431ofthe 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