Company: CHD
Filing Date: 2025-02-13
Form Type: 10-K
Source: 0000950170-25-019801
Chunk: 59

Company: CHURCH & DWIGHT CO INC /DE/
Filing Date: 2025-02-13
Form: 10-K
Item: Item 1
Chunk 59
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In many countries outside the United States, to distribute a medical device lawfully, we must demonstrate conformity to local or regional standards for quality, safety and performance. For class II medical devices, we must obtain either government approval or certification from an accredited and approved Notified Body ("NB") that also performs periodic planned and surprise audits of our files and our quality system. These audits are shared in some cases, specifically among regulators in the U.S., Canada, Australia, Brazil, and Japan. Modification to a certified device generally requires government or NB review and approval prior to implementation of the change.  Additionally, all safety incidents reported to a Health Authority must also be reported to the NB.

OTC/Pharmaceutical and Cosmetic Requirements

We market over-the-counter (“OTC”) pharmaceutical products, such as topical acne products, anticavity toothpaste, anticavity rinse, antiperspirant, hemorrhoid relief, skin protectant, antinauseant, oral analgesic and sunscreen drug products, that are subject to FDA and foreign regulation.  Under the U.S. OTC monograph system, OTC pharmaceutical products that meet established conditions are generally recognized as safe and effective and do not require the submission and approval of a new drug application.  The FDA OTC monographs include well-known ingredients and specify requirements for permitted indications, required warnings and precautions, allowable combinations of ingredients and dosage levels.  Pharmaceutical products marketed under the OTC monograph system must conform to specific quality, formula and labeling requirements.  Following the passage of the CARES Act, FDA is updating and working to finalize current monographs, including those that affect our oral care products and HERO sunscreens.  With these new regulations, OTC products will now need to be “state of the art” and will have significant focus on Good Manufacturing Practices (“GMPs”), especially manufacturing, final formulation testing, stability testing, and safety incident reporting.  Products not in the monograph system can be deemed to be 

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unapproved new drugs and can be forced from the market.  This is particularly the case for homeopathic drug products like certain ZICAM products.  Both the FDA and the FTC have taken the position that homeopathic products are unapproved new drugs.  Regulatory action against these products is deemed unlikely unless the products present an unreasonable safety risk.  ZICAM homeopathic products are not currently perceived to pose such risk.

All facilities where OTC pharmaceutical products are manufactured, tested, packaged, stored or distributed must comply with current Good Manufacturing Practices