Glycerin, Oleate Cream Marketed Under Different Brand Still Not Approved As OTC Contraceptive

“Wise Women’s Choice, formerly known as Smart Women’s Choice contraceptive cream is 99.8% effective,” FDA reports finding on firm’s website.

• Source: Shutterstock

Changes to the product name and the manufacturer’s location didn’t keep a vaginal cream promoted as a contraceptive with nearly 100% efficacy off the Food and Drug Administration’s radar.

The Office of Unapproved Drugs and Labeling Compliance in the agency’s Center for Drug Evaluation and Research on 26 July...

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Different Name, Same Contamination, Recall Problems For US Homeopathic Nasal Spray Firm

Green Pharmaceuticals’ SnoreStop Nasal Spray, previously marketed as “NasoSpray,” still is available even though agency officials on multiple occasions for a month recommended a recall after an April inspection found “gross microbial contamination” in one lot.

HI-Health (Free-1): Why Children with ADHD Hate Bedtime: Solutions to ADHD Sleep Problems

 
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Children with ADHD often struggle with bedtime due to restless minds, difficulty winding down, and heightened sensitivity to nighttime distractions. This article explores the reasons behind these sleep challenges and offers practical solutions.

Check Contract Manufacturers' GMP Compliance, US FDA Warns Eye Drop Firm, Lip Balm Provider

 

Request to recall eye drops should be fulfilled promptly and businesses providing lip balms as promotional products must verify contract manufacturers are compliant, recent FDA warnings states. Additional letters went to Jordanian firm about testing alcohol for methane and to a Chinese firm advised that compliance with China’s quality control standards isn’t sufficient.

Baby Wipes From Firms In China, Vietnam On US Import Alert; Another Warning On Delta-8 THC

 

Warning letters to SuXiang Medical Instrument in China and Yahon Enterprise in Vietnam among recent warnings FDAS sent to OTC drug and supplement manufacturers, including a Florida firm, White Label Leaf, warned about selling gummies containing delta-8 THC, and other OTC skin care product firms.

More from Policy & Regulation

Beauty Brands Not On TikTok Shop ‘Really Missing Out’ – KO-Pack

 

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.”

Perrigo Securities Class-Action Settlement Awards Attorneys’ Fees, Expenses Lower Than Requested

 

Court order dismisses claims against Perrigo and Joseph Papa, its former CEO, with prejudice. Settlement also bars any claim against plaintiffs and class members, “whether arising under state, federal, common or foreign law,” alleging liability for losses.

ACNU Switch And IND Exemption Final Rules Targeted For October In FDA Regulatory Goals

 

Semi-annual regulatory agenda of non-binding target dates also sets December goal for an NPRM to recognize N-acetyl-L-cysteine as a lawful dietary ingredient. Like IND exemptions rule, item on NAC included for first time in FDA’s list.