FDA asks RIJ Pharmaceutical, which recalled a dozen products last year, to provide plans for developing a solid water system design and mixing process. It warns private label manufacturer about contaminated, "‘super-potency" OTC drugs that resulted from GMP violations.

Trademarks registered and published for opposition with USPTO in Class 3 – cosmetics and cleaning Preps, and Class 5 –pharmaceuticals. Marks for vitamin, mineral and supplement products also are registered or published for opposition in both Class 3 and Class 5.

In his first speech to agency staff, Acting Commissioner Norman Sharpless says FDA will continue working on issues including food safety and nutrition drug, and he is not approaching the post like a temporary caretaker. Sharpless said his appointment does not reflect attempt by President Trump or HHS Secretary Alex Azar to force FDA to change direction set by Scott Gottlieb.

Tylenol brand consumption grows 10% on sales of Rapid Release Gel and Tylenol Arthritis, reaching top spot among analgesic products in the US, J&J says. Retailers' inventory builds as a result of prior-year supply constraints driven by Hurricane Maria also helped drive growth.

The Cruelty-Free Cosmetics Act, S 214, would ban the sale of cosmetics developed with animal testing that’s conducted four years or more after enactment, ostensibly including testing undertaken to comply with foreign regulations. The sole exemption is for animal testing that is Health Canada-authorized.

Nakissa Sadrieh, director of cosmetics at FDA and the agency’s CIR liaison, floated the three potential review priorities at the CIR Expert Panel’s April 8-9 meeting in Washington. It’s the most for-cause targets proposed by the agency in recent memory, and CIR leadership noted that they pose considerable challenges.

Tylenol brand consumption grows 10% on sales of Rapid Release Gel and Tylenol Arthritis, reaching top spot among analgesic products in the US, J&J says. Retailers' inventory builds as a result of prior-year supply constraints driven by Hurricane Maria also helped drive growth.

The Cosmetic Ingredient Review Expert Panel is taking its first look at brown algae-derived ingredients, with 32 passing muster at the panel’s April 8-9 meeting in Washington. Salicylic acid and fatty acids were among ingredients that received final safe verdicts, while four ingredient groups drew insufficient data announcements. Finally, parabens got tabled and MCI/MI was reopened for updates.

Governor Andrew Cuomo’s Consumer Right to Know Act, New York’s answer to Prop 65 in California, was scuttled by legislators in their budget bill signed into law April 12. However, related talks are ongoing in the state’s legislature, where the Safe Cosmetics Act is on the table again this session.

S-equol in Equelle menopause supplement; antioxidant support for PTSD symptoms; supplement targets uremic toxins; green tea for heart health; and CartiJoint with Bio-Curcumin Curcugree.

Nutrition, health and wellness productfirm launches its CBD sales with Irwin's Naturals products and also offers SpaRoom oils. Green Gorilla and Folium Biosciences are the latest nutritional product firms to offer CBD-containing supplements in gummy format.

Annals of Medicine study finds at least 1,000mg/day calcium supplementation associated with increased risk of cancer, but no association of cancer and high levels of calcium from foods. Natural Products Association says study included an ‘unhealthy’ cohort of patients.

Trademarks registered and published for opposition with USPTO in Class 3 – cosmetics and cleaning Preps, and Class 5 –pharmaceuticals. Marks for vitamin, mineral and supplement products also are registered or published for opposition in both Class 3 and Class 5.

FDA extends sunscreen proposed rule comment period; American Kratom Association AKA webinar counters ‘incorrect’ headlines; ProBiora promotes brand with comic book; and Allulose labeling draft guidance includes enforcement discretion.

Consumers need more support to help them accurately interpret nutrition and health claims made on foods, including food supplements, a study across five EU markets suggests. Nutrition claims and health claims are regularly confused by consumers, and their technical wording often means they are misunderstood or not understood at all.

The European Medicines Agency is right now looking into how real-world data and evidence can be used to improve regulatory systems and extend access to OTC medicines within the European Union, the agency's executive director Guido Rasi told the recent AESGP Regulatory Conference in Amsterdam.