Health Reform WK-EDGE HHS reveals changes coming to health programs and FDA-regulated products
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Wednesday, July 10, 2019

HHS reveals changes coming to health programs and FDA-regulated products

By Rebecca Mayo, J.D.

HHS’s semiannual rule-making inventory includes changes to the labeling of a number of OTC drug products, large color graphic warnings on tobacco products, and updated definitions for "healthy" and "gluten-free" food products.

HHS has published the semiannual inventory of rule-making actions under development. The agenda presents the regulatory activities that HHS expects to undertake in the foreseeable future. Included on the agenda is a proposed rule to prohibit discrimination on the basis of race, color, national origin, sex, age, and disability under any health program receiving Federal financial assistance. Other major actions include labeling of over-the-counter (OTC) drug products, updates to sunscreen and sun lamp regulations, updated warnings on tobacco products, and updates to food product labeling (Notice, 84 FR 29624, June 24, 2019).

OTC drug products. Several proposed and final rules are set to resolve issues relating to over-the-counter (OTC) drug products such as labeling of sodium phosphate laxative drug products, the evaluation of antiseptic rubs, and weight control products containing phenylpropanolamine. One proposal is a rule to add the common cold indication to certain over-the-counter (OTC) antihistamine active ingredients on a pilot basis to reduce unnecessary duplication and differences.

Other actions would address external analgesic products including patches, plaster, and poultices as well as internal analgesic products by addressing acetaminophen safety, while another would address products marketed for children under two years old and weight- and age-based dosing for children’s products. Safety and efficacy of pediatric cold and cough products and the labeling of cold and cough products containing an oral bronchodilator (ephedrine and its salts) in combination with any expectorant would also be addressed.

Sun care. A proposed rule would address the general recognition of safety and effectiveness (GRASE) status of the 16 sunscreen monograph ingredients and discuss the marketing of these ingredients without submitting new drug applications for premarket review as well as sunscreen dosage forms and maximum SPF values. The performance standard for Dunlap products would also be updated to improve safety, reflect new scientific information, and work towards harmonization with international standards. While another rule would apply device restriction to sunlamp products including ultraviolet lamps and tanning beds and booths.

Tobacco products. A proposed rule would establish nicotine exposure warning requirements for liquid nicotine and nicotine-containing e-liquids that are made or derived from tobacco and intended for human consumption. This would include novel tobacco products such as dissolvable, lotions, gels, and drinks. Another proposed rule would require color graphics depicting the negative health consequences of smoking to accompany textual warning statements on cigarette packages and in cigarette advertisements. The warnings would occupy the top 50 percent of the area of the front and rear panels of cigarette packages and at least 20 percent of the area of cigarette advertisements. The FDA also proposed regulations that would allow the FDA to administratively detain tobacco products encounter during inspections that it has reason to believe are adulterated or misbranded.

Food products. A proposed rule would update the definition for the nutrient content claim of "healthy" and revise requirements for when the claim can be used in food labeling. Another would update FDA regulations to remove all mention of partially hydrogenated oils and revoke all prior sanctioned uses based on FDA findings that they may cause the food to be unsafe. A final rule would establish requirements for labeling foods "gluten-free" that are fermented or hydrolysis or that contain fermented or hydrolysis ingredients. While another final rule would modernize the standards for yogurt, including low-fat and nonfat yogurt, to allow for technological advances to preserve the basic nature and essential characteristics of yogurt.

Medicare. A proposed rule would reform the requirements for long-term care facilities to participate in the Medicare and Medicaid programs. While a final rule would update the requirements that hospitals and critical access hospitals must meet to participate in the Medicare and Medicaid programs. An annual proposed rule would revise payment policies under the Medicare physician fee schedule and make other policy changes to payment under Medicare Part B. Another annual proposed rule would revise the Medicare hospital outpatient prospective payment systems to implement statutory requirements and changes.

Annual final rules would revise the Medicare hospital inpatient and long-term care hospital prospective payments systems for operating and capital-related costs, update the payment rates under the Medicare prospective payment systems for home health agencies, and revise the Medicare hospital outpatient prospective payment system to implement statutory requirements and changes. Other annual final rules would revise payment policies under the Medicare physician fee schedule and make other policy changes to payment under Medicare Part B as well as update the bundled payment system for ESRD facilities and update the quality incentives in the ESRD program and implement changes to the DMEPOS competitive bidding program.

FederalRegisterIssuances: Notices AccessNews AgencyNews DrugNews GeneralNews MedicaidNews MedicarePartANews MedicarePartBNews MedicarePartCNews MedicarePartDNews ProgramIntegrityNews

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