Company: PBH
Filing Date: 2025-05-09
Form Type: 10-K
Source: 0001295947-25-000017
Chunk: 10

Company: Prestige Consumer Healthcare Inc.
Filing Date: 2025-05-09
Form: 10-K
Item: Item 1
Chunk 10
---
 to be delineated further by the FDA in the next few years.

Certain of our U.S. OTC drug products require the submission of a New Drug Application (“NDA”) or Abbreviated New Drug Application (“ANDA”). These specific OTC drug products cannot be marketed until FDA approves the NDA or ANDA, and, 

8

after approval, are manufactured and labeled in accordance with an FDA-approved submission.  These products are subject to reporting requirements as set forth in FDA regulations. 

Certain of our U.S. OTC Healthcare products are medical devices regulated by the FDA through one of three classes of medical devices:  Class I devices are low risk devices, Class II devices are intermediate risk devices and Class III are high risk devices.  The class of the device determines, among other things, the type of pre-market submission/application required by FDA to market the device, and this system may involve pre-market clearance or approval.  During the review process, the FDA makes an affirmative determination as to the safety and efficacy of the device, as well as the sufficiency of the label indications, directions, cautions and warnings for the medical device in question.

Certain of our products are considered cosmetics regulated by the FDA through the FDC Act and the Fair Packaging and Labeling Act.  The FDA does not require pre-market clearance for cosmetics, but manufacturers must ensure the products are not adulterated or misbranded.  Furthermore, Congress passed the Modernization of Cosmetics Regulation Act of 2022 (“MoCRA”) in December 2023, which expands FDA authority to regulate cosmetics.  MoCRA provides new FDA authorities related to records access, mandatory recalls, adverse event reporting, facility registration, product listing and safety substantiation of products. 

In accordance with the FDC Act and FDA regulations, we and our third-party manufacturers of U.S. products must also comply with the FDA’s current Good Manufacturing Practices (“cGMPs”).  The FDA inspects our facilities and those of our third-party manufacturers periodically to determine that both we and our third-party manufacturers are complying with cGMPs.  Even where we are not performing manufacturing activities in our own facilities, cGMP requirements include oversight responsibilities over contract manufacturers. 

Our dietary supplement products are governed by the Dietary Supplement Health and Education Act of 1994 ("DSHEA"), which defines and regulates dietary supplements.  Under DSHEA, FDA published a final rule that requires persons who manufacture, package, label or hold a dietary supplement to