The proposed rule will require child-resistant packaging for OTC and prescription products containing the equivalent of 0.08 milligrams or more of an imidazoline.
CHPA encourages FDA to work with industry and other stakeholders to develop and discuss alternatives to an ingredient ban. Given the extremely low levels of gluten in OTC drugs today, a ban would unnecessarily disrupt the supply chain and may limit the availability of important products relied on by millions of consumers.
CHPA takes this opportunity to share comments on the agency's proposed rule for Medicare, Medicaid, Children's Health Insurance Programs; Transparency Reports and Reporting of Physician Ownership or Investment Interests.
The industry favors and supports the development of reasonable guidance. However, the agency’s attempt to redefine the NDI notification process contradicts the letter and spirit of DSHEA. The Draft Guidance would undo nearly two decades of agency practice and policy.
The following comments address 1) data and information on sunscreen spray dosage forms to confirm their eligibility for inclusion in the final sunscreen monograph and 2) data and information supporting the inclusion of powder sunscreens in the final monograph.
We support the Agency's proposed decision to allow sunscreen products to be labeled with SPFs up to SPF 50+ and understand that higher SPF levels may be considered if supporting data are submitted to the Agency for review.
