Ingredients & Safety
Engaging with EU member state legislators, stressing the impact of national EPR systems on the accessibility, availability, and affordability of medicines, reformulating products to reduce their financial contribution, and lobbying for expanding the scope of EPR schemes to include other polluting industries are all ways that the European consumer health industry can try and influence the way that the revised Urban Wastewater Treatment Directive is transposed into national legislation, law firm Mason Hayes & Curran explains.
France's food safety regulator ANSES is proposing a reproductive toxicity category 1B classification for CBD under the EU's CLP regulation, which would mean an effective ban on CBD in cosmetics and foods. However, French hemp industry association UIVEC hopes that new evidence coming out of a European Commission review will put the issue to bed before it gets that far.
Reclassifying ethanol as a carcinogenic, mutagenic, or reprotoxic substance - something the European Chemicals Agency seems likely to do in the near future - would be “tantamount to a de facto ban” with “fatal consequences” for medical care in Germany, says Pharma Deutschland in a joint paper with 13 other German healthcare industry associations.
Two AESGP papers reviewing the evidence for AMR risk associated with a range of OTC antifungals and antivirals conclude there is litte to no risk associated with the responsible self-care use of such medicines.
“Protecting the environment is a shared responsibility. It is unfair to expect only two sectors to fund wastewater treatment modernization and operation,” argues AESGP director general Jurate Švarcaite.
Supplements already under close scrutiny in the EU have been linked to severe adverse effects on the musculoskeletal system and liver, even at low doses.
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.