May 25, 2022
The Consumer Healthcare Products Association (CHPA) represents the leading manufacturers and marketers of nonprescription, over‐the‐counter (OTC) medicines, dietary supplements, and consumer medical devices. Through science, education, and advocacy, CHPA works to ensure consumer access to safe, effective, and convenient OTC medicines and personal healthcare products that consumers rely on to feel and stay healthy. Our current federal legislative priorities include:
The OTC Monograph system is the regulatory framework under which the U.S. Food and Drug Administration (FDA) ensures that well-established OTC ingredients and products are safe and effective for use by consumers. In March of 2020, President Trump signed H.R. 748, the CARES Act, into law. This COVID-19 relief package included the bipartisan Over-the-Counter Monograph Safety, Innovation, and Reform Act which modernized the OTC regulatory structure and allows the FDA to collect user fees to support regulation of the industry. CHPA is committed to ensuring a smooth implementation of the new law, which will provide increased efficiency and transparency as well as expand consumer choice of safe and effective OTC medicines.
The CARES Act also included a provision that restores some OTC medicines and adds menstrual care products to Health Savings Account (HSA) and Flexible Sending Arrangement (FSA) qualified medical expense eligibility list. CHPA is working to educate consumers about how to make the most of this new benefit to save money on the products they know and trust. CHPA continues to advocate that Congress and the IRS increase consumer access to personal healthcare products via HSA/FSA programs through the inclusion of additional OTC medicines, dietary supplements, and consumer medical products.
Regulation of the dietary supplement industry has remained largely unchanged since the Dietary Supplement Health and Education Act (DSHEA) was signed into law in 1994. This regulatory structure has not kept up with growth in consumer demand for dietary supplements and FDA does not have adequate tools to respond to the needs of today’s marketplace. CHPA supports regulatory and legislative proposals that will modernize the DSHEA framework, increase FDA oversight and enforcement against illegal products, and provide a clear path for innovation.
The 2018 Farm Bill allowed for the farming of hemp, containing no more that 0.3 percent THC for commercial purposes but did not include a process for the inclusion of CBD in dietary supplement products. Despite regulatory uncertainty about CBD as an ingredient, robust consumer demand has resulted in exponential growth in sales of ingestible CBD products. CHPA supports a clear regulatory pathway for the inclusion of CBD in dietary supplements to allow legitimate products to remain on the market while protecting consumers against those making specious health claims and/or not abiding by good manufacturing practices.
In the wake of the COVID-19 pandemic, proposed “Buy American” and other international trade policy changes could lead to shortages of ingredients needed to produce OTC medicines and dietary supplements, even when the final product is manufactured in the United States. CHPA member companies have a robust domestic manufacturing footprint, with roughly 1,000 facilities from coast to coast. CHPA supports policies that enable a functioning supply chain to deliver products to consumers where and when they need them. As a founding member of the Buy Safe America Coalition, CHPA also supports legislation that would protect consumers from potentially dangerous counterfeit products.
Millions of Americans safely use OTC medicines as directed on the label. However, given the wide accessibility of these consumer products, we recognize that there are some consumers who may intentionally misuse or abuse certain OTC medicines. CHPA supports policies that address misuse in a targeted way to protect vulnerable populations while ensuring Americans have access the medicines they need.
The U.S. Food and Drug Administration has jurisdiction over $1 for every $5 spent in the U.S. with products ranging from food and drugs to medical devices and cosmetics. FDA has been chronically underfunded for many years and it is an increasing challenge for the agency to fulfill its myriad of responsibilities in ensuring the safety of the nation’s food and drug supply. As a founding, active member of the Alliance for a Stronger FDA, CHPA advocates for significant increases in FDA funding.
CHPA is a founding member of the Buy Safe America coalition. The Buy Safe America Coalition represents a diverse group of responsible retailers, consumer groups, manufacturers, intellectual property advocates, and law enforcement officials who support efforts at all levels of government to protect consumers and communities from the sale of counterfeit and stolen goods.
The legislation underpinning this effort is the INFORM Consumers Act. Today, third party sellers on platforms like eBay, Amazon, Alibaba, and others, do not have to verify their name/address/identity. The INFORM Consumers Act requires these sellers to legally verify their name and address as well as provide a tax ID number. None of these requirements currently exist, and therefore the opportunity for “fly-by-night” sellers to operate on these platforms remain, and we’ve seen consumer healthcare products that are therefore fraudulent appear.
As this legislation, and other common-sense approaches to protecting consumers make their way through the legislative process, CHPA will remain at the forefront of these efforts.
CHPA supports candidates for federal office who share our business philosophy.
The CHPA Political Action Committee (PAC) was established in 1975 with the goal of supporting candidates for federal office who support our industry or hold key Committee or leadership roles.