BILL ANALYSIS C.S.H.B. 2838 Public Health Committee C.S.H.B. 2838 Committee Report (Substituted) 04-19-95 BACKGROUND The Texas Food, Drug and Cosmetic Act (Act) was first enacted in 1911 by the 32nd Legislature, and then recodified as Chapter 431, Health and Safety Code in 1989 by the 71st Legislature. The Act is a "cradle to grave" statute encompassing the manufacture, sale and distribution to an end consumer of food, drugs, devices and cosmetics. The Act conforms with the Federal Food, Drug and Cosmetic Act and has been amended over the years to maintain conformance with the Federal Act. In recent years, a need to regulate persons selling products in Texas has arisen. This bill would give the Texas Department of Health (TDH) authority to regulate adulterated or misbranded components, or those posing an immediate threat. PURPOSE H.B. 2838 as substituted, amends the Texas Food, Drug and Cosmetic Act to conform with the Federal Food, Drug and Cosmetic Act, and gives the TDH authority to regulate those selling a food, drug, device, or cosmetic, with specified restrictions. RULEMAKING AUTHORITY It is the committee's opinion that this bill does not expressly grant any additional rulemaking authority to a state officer, department, agency, or institution. SECTION BY SECTION ANALYSIS SECTION 1. Amends Sec. 431.002(23), Health and Safety Code, by defining "manufacture" as follows: (A) The specified processing of food. (B) The specified processing of drugs and drug products. (C) The specified processing of a device. (D) The specified making of any cosmetic product. SECTION 2. Amends Sec. 431.021(h), Health and Safety Code, to add that the sale within this state of any food, drug, device, or cosmetic that is adulterated or misbranded is prohibited. SECTION 3. Amends Sec. 431.042(b), Health and Safety Code, by deleting the terms "prescription" and "restricted" from the inspection authority of the Texas Department of Health (TDH), and adding cosmetic to the items covered by this section. SECTION 4. Amends Sec. 431.045(a) and (c), Health and Safety Code, by adding that the Commissioner of the TDH may issue an emergency order that is restrictive in nature in relation to the manufacture or sale of specified items. Establishes that a hearing on any emergency order issued under this provision is required to be held under the Administrative Procedure Act (Chapter 2001, Government Code), and the Texas Board of Health (Board) formal hearing rules. SECTION 5. Amends Sec. 431.221(4), Health and Safety Code, to include in the definition of "manufacture" repackaging or otherwise changing the container, wrapper, or labeling of any food. SECTION 6. Effective date: September 1, 1995. SECTION 7. Emergency clause. COMPARISON OF ORIGINAL TO SUBSTITUTE H.B. 2838 as substituted defines the different aspects of "manufacture" to conform with the Federal Food, Drug, and Cosmetic Act. The substitute also removes the provision in the original bill which allows the TDH to regulate financial data relating to the manufacture of a food, drug, or a device, as the TDH only wants to regulate the components in regard to where they come from and where they will be sold. The substitute clarifies that the Commissioner will regulate the sale of a food, drug, device or cosmetic. The substitute also removes the original Section 4 regarding the actions to be taken to regulate violations of this chapter, because this is covered by Section 2 of the substitute. SUMMARY OF COMMITTEE ACTION H.B. 2838 was considered by the Public Health Committee in a public hearing on April 19, 1995. The committee considered a complete substitute for the bill. The substitute was adopted without objection. The bill was reported favorably as substituted, with the recommendation that it do pass and be printed and be sent to the Committee on Local and Consent Calendars, by a record vote of 7 AYES, 0 NAYS, 0 PNV, 2 ABSENT.