Ingredients & Safety
Australian government finds an insufficient body of new evidence to support Rx-to-OTC switch of erectile dysfunction drug sildenafil since it was last considered in 2020.
It is well established that antibiotics disrupt the human gut microbiome, but what is not so well established is the use of probiotics to restore it, find the authors of a recently published scientific literature review.
UK food toxicity committee says substantial exceedances of the Acceptable Daily Intake of turmeric - such as through excessive supplement use - represents a potential health risk to humans.
The Expert Panel for Cosmetic Ingredient Safety issued a revised tentative amended report for p-phenylenediamine and related ingredients during its 171st meeting.
FSA now aims to send the first recommendations for the authorization of CBD novel food products to UK government ministers in 2025, according to its most recent board meeting. The agency is closely scrutinizing trace THC levels and is planning to ban use of CBD food products by under 18s.
Interest in probiotics in APAC is expected to continue to grow driven in part by the “K-food” (Korean food) wave, Euromonitor International reports.
EMA's PRAC clarifies risk of high anion gap metabolic acidosis (HAGMA) in users of OTC paracetamol with new package leaflet and SmPC warnings.
European Food Safety Authority finds no link between creatine supplementation and improved cognitive function.
Although FDA concluded OTC oral phenylephrine is ineffective as a nasal decongestant in doses up to highest studied level, federal preemption precludes challenges to agency’s regulation of labeling for phenylephrine and other Rx and OTC drugs, according to recent decision in New York federal court.
Dietary supplement ingredient promising enhanced memory and mental clarity marketed widely across the US has been authorized for sale in Europe.
A study recently published in peer reviewed journal Nutritional Bulletin advises those who follow a vegan and vegetarian diet to supplement with vitamin B12, especially women of childbearing age, including those who are planning pregnancies or are lactating, who are "generally higher risk of vitamin and mineral inadequacies and deficiencies, including but not limited to vitamin B12."
EFSA has published new guidance to assist companies navigating the EU’s novel food authorisation process. HBW Insight speaks to experts Dr Mari Eskola of Medfiles and Dr Jérôme Le Bloch of FoodChain ID who offer differing views on the benefits and drawbacks of the guidance for industry.
FDA’s OTC office director details a 2023 guidance as opening doors for NRT innovation at recent public meeting, but researchers and an industry executive note the most recent approval in the US for an innovative NRT was more than 20 years ago and say FDA isn’t allowing sufficient flexibility for approvals of new products or indications other than cessation related to quitting smoking.
FDA tobacco programs chief emphasizes moving smokers to lower risk alternatives and NIDA executive encourages proposals for e-cigarettes as nicotine replacement treatments. FDA also seizes $76m in unauthorized e-cigarettes.
Qnovia notes NRT inhalation product recently received investigational new drug clearance from FDA as agency and NIH say innovation needed smoking cessation to help improve rate of success for quitting the habit that kills around 500,000 US consumers annually.
Now that reporting of cosmetic ingredient use to FDA is no longer voluntary, the Cosmetic Ingredient Review is wading through a tide of data generated by MoCRA registration and listing deadlines.
The Washington State Department of Ecology will try to work with companies that violate the Toxic Free Cosmetics Act, rather than reflexively imposing the $5,000-per-violation fine for first-time offenders, says the law’s implementation planner. She noted financial assistance is available for small businesses, as well as incentives for companies adopting measures “beyond compliance.”
Requests for “enforcement actions are not within the scope of FDA’s citizen petition procedures,” CDER says, rejecting petition dosing device firm Parenteral Technologies submitted as it prepares for workshop on Pediatric Research Equity Act requirements for OTC NDA sponsors.
Toxic-Free Cosmetics Act planner Shari Franjevic acknowledges the Washington State Department of Ecology is authorized to use enforcement discretion regarding the new law’s 1ppm limit on trace lead in cosmetic products, effective 1 January 2025, or raise the ceiling via rulemaking. But it does not seem inclined to do either based on data known to the department at present.
CRN/Radicle Trailblazing Woman Award to ChromaDex’s Yasmeen Nkrumah-Elie; Nourish’s TV ad campaign features US soccer star Alex Morgan; Vitamin Shoppe BodyTech Elite Altered Strength line sponsors Team Red, White & Blues; contract pharma/consumer health product development firm LabConnect appoints Wesley Wheeler CEO; Avanos’ Game Ready is “Recovery Partner” of NFL’s Nick Bosa; Akita adds Robert Hanson to advisory board; and BODi has wrestler as brand ambassador