Laserfiche WebLink
<br />February 8, 2021 <br /> <br />Chairwoman Nicole E. Lowen <br />Hawaii State Capitol, Room 425 <br />Honolulu, HI 96813 <br /> <br />ġǦӳ ¦V ѳѵѳѸ úʂʂɞʍǦǞӿ ʅǦʄʪǦʍʚȥɓș ƠɑǦɓǞɑǦɓʚ <br /> <br />Dear Chairwoman Lowen, <br /> <br />On behalf of the Consumer Healthcare Products Association (CHPA), the national <br />trade association representing the leading manufacturers of over-the-counter (OTC) <br />hank <br />you for the opportunity to comment on HB 1316 related to packaging waste. While <br />we appreciate the goal of the proposal outlines in HB 1316, packaging regulation of <br />dietary supplements, drugs, and medical devices is the purview of the federal <br />government and thus risks conflicting with existing federal law. As a result, we <br />oppose passage of HB 1316 unless amended to include appropriate exemption <br />language for Food and Drug Administration (FDA) approved products. <br /> <br />Our industry is very committed to advancing sustainable practices and shares the <br />goal of minimizing environmental impacts created by product packaging. Many of <br />our member manufacturers already have recycling efforts in place and encourage <br />the development of more sustainable products, while remaining compliant with <br />existing federal law. <br />WɞɓȖȿȥǗʚ ˂ȥʚȠ hˌȥʍʚȥɓș –ǦǞǦʅƠȿ ÕƠ˂ <br />The packaging of drugs, dietary supplements, and medical devices is very complex <br />and highly regulated by the FDA to ensure the safety, quality, and stability of the <br />products sold. It is a multi-faceted and highly regulated space that forces <br />manufacturers to consider several factors beyond just the aesthetic appeal of the <br />package itself. <br />Specifically, FDA regulates drug product packaging under Good Manufacturing <br />Practices regulations (GMPs) (21 C.F.R. Part 211, Subpart G), including material <br />examination and usage criteria (§211.122), packaging and labeling operations (§ <br />211.130), tamper-evident packaging (§ 211.132), and expiration dating (§ 211.137). <br />Certain drugs and dietary supplements are also regulated by the Consumer Product <br />Safety Commission (CPSC) under the Poison Prevention Packaging Act (PPPA), which <br />requires child-resistant packaging. Manufacturers are required to test their packaging <br />and certify compliance. In addition, drug products for which packaging does not <br />comply with PPPA packaging and labeling regulations are misbranded under the <br />Food Drug and Cosmetic Act (21 U.S.C. § 352(p)). <br /> <br />