INGROWN TOENAIL FINAL RULE CONTAINS NO MONOGRAPH INGREDIENTS and, therefore, any product marketed for that use will be considered a "new drug" by FDA, effective March 9, 1994. The ingrown toenail final monograph primarily affects two ingredients that had been listed in Category III (data insufficient to demonstrate safety and efficacy) in the September 1982 tentative final monograph -- tannic acid and sodium sulfide. In addition, FDA said in the final monograph that it is "not aware of any data that establish the safety and effectiveness of anesthetic ingredients for the relief of . . . pain" associated with ingrown toenail. Consequently, the agency added, "benzocaine, chlorobutanol, and dibucaine are nonmonograph conditions for this use." FDA ruled on the two Category II (not safe and effective) ingredients in the TFM -- chloroxylenol and urea -- as part of the agency's "negative monograph" rulemaking in November 1990 when FDA cleared out 232 Category II and Category III ingredients. Those ingredients, FDA noted, "have already been removed from OTC ingrown toenail relief drug products." The agency noted in the monograph that it is "only aware of a few products containing other ingredients" including "two combination drug products containing chlorobutanol and tannic acid and one containing benzocaine and tannic acid." Whitehall's Outgro, which contains 25% tannic acid and 5% chlorobutanol, and Schering-Plough's Dr. Scholl's Ingrown Toenail Reliever, which contains 5% tannic acid and 5% chlorobutanol, are among the products that will be affected by the monograph. Two studies in support of monograph status for tannic acid and two studies in support of sodium sulfide were submitted to FDA in response to the proposed rule on ingrown toenail ingredients. FDA said it reviewed the new clinical data and "determined that [the studies] are inadequate to support the effectiveness of tannic acid for the relief of ingrown toenails." The agency found that subject selection criteria in the first tannic acid study were not followed and that the grading scale used in the study was "highly subjective" and contained "inconsistencies between investigators and subjects." The second study, FDA said, looked at tannic acid's effect on skin hardening and did not address any other ingrown toenail symptoms and, therefore, could only "provide support" for tannic acid as a "skin hardener." FDA found that the sodium sulfide studies supported the ingredient's effectiveness. However, the study also showed a "high incidence of adverse reactions" including burning sensations and irritation. FDA concluded that the incidence of side effects and the need for subsequent professional advice "makes this ingredient unacceptable for OTC use."
Join thousands of industry professionals who rely on HBW Insight for daily insights
Already a subscriber?
The US FTC’s contention that ‘notice and choice’ has failed as the cornerstone of consumer privacy regulation and must be abandoned in favor of data minimization and other more stringent measures does not adequately account for the complexity of business practices and consumer behavior, FTC commissioner Melissa Holyoak asserted at the NAD’s 2024 Annual Conference.
FTC Commissioner Melissa Holyoak says the agency has acted outside the bounds afforded by Congress, citing several areas within consumer protection, including a recent update to the final rule for the Health Breach Notification Rule and the commission’s use of notices of penalty offense to serve as the basis for Section 5 settlements.
At one year, TikTok Shop conjures the early days of Amazon, representing the ‘Wild West’ of beauty ecommerce, said co-founders of private label and contract manufacturing company KO-Pack at the IBA Cosmetics Convergence Fall 2024 Virtual Symposium, “The Promise and Pitfalls of TikTok Shop.”
Editor’s note: This is your final call to participate in the survey to better understand our subscribers’ content and delivery needs. The deadline is 20 September.
Provisions in bill approved by Agriculture, Rural Development, FDA and Related Agencies Subcommittee aren’t likely to pass largely because they set a price too high for delta-8 THC and other ingredients to meet the definition of hemp as a de-scheduled substance.
Limited capacity and a two-to-three year timescale for reformulation could mean that many VMS supplements disappear from the market, warns EPPA partner Alexandra Bocquillion, speaking at the AESGP Annual Meeting in Warsaw, Poland.
The White House requested $6.8bn for the FDA, down 3.9% from the current funding level, but does not propose any legislative changes. In previous years, the agency used the budget process to seek statutory fixes specific to generic drugs and shortages.
