Ingredients & Safety

EMA Clarifies Paracetamol Warnings On Risk Of Blood And Fluid Abnormality

 
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EMA's PRAC clarifies risk of high anion gap metabolic acidosis (HAGMA) in users of OTC paracetamol with new package leaflet and SmPC warnings.

EU Follows UK In Rejecting Creatine Cognitive Health Claim

 
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European Food Safety Authority finds no link between creatine supplementation and improved cognitive function.

False Advertising Challenges To OTC Phenylephrine Efficacy Ineffective Against Federal Preemption

 

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.

Magnesium Brain Health Supplement Sold Across US Authorized As Novel Food In EU

 
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Dietary supplement ingredient promising enhanced memory and mental clarity marketed widely across the US has been authorized for sale in Europe.


Veganism: Study Demonstrates Improved Vitamin B12 Status With Supplementation

 
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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."

Help Or Hindrance To Food Supplement Innovation? Experts Assess New EU Novel Food Guidance

 
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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.

US FDA Keeps Cessation As ‘Gold Standard’ For NRT Indication As Critics Question Its Worth

 

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, NIH Officials Encourage E-Cigarette NRT Innovation As Task Force Seizes Illegal Products

 

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.


FDA Clears Qnovia’s NRT Inhalation IND, Commits To ‘Stimulating’ Smoking Cessation Innovation

 

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.

New Era For CIR: Expert Panel Meets As Mandatorily Reported Ingredient Data Pours In From FDA

 
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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.

Washington State TFCA Violators Likely To Face Conversation Before Penalties – DOE

 

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.”

US FDA’s Petition Procedures No Place For OTC Acetaminophen Pediatric Dosing Enforcement

 

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.


Washington State TFCA Stakeholders: Don’t Hold Your Breath For Higher Lead Limit

 

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. 

US Nutrition Market People News: CRN/Radicle Award, Nourish, VSI, LabConnect, Akita, More

 

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

GSK Tab To Clear Zantac Litigation Ledger Of 93% Of Complaints Pending In State Courts: $2.2Bn

 

UK pharma also reaches agreement in principle, subject to DoJ approval, to pay $70m to resolve a whistleblower complaint filed by Valisure, the testing lab which in 2019 raised concerns about a potential link between the use of drugs containing ranitidine, a histamine-2 blocker, and cancer.

FDA Workshop To Consider Pediatric Research Rules Compliance By OTCs Available Through NDAs

 

NDAs for additional OTC products containing acetaminophen and/or NSAIDs and indicated for use by children between 2 and less than 12 years old would trigger compliance by application sponsors with the act passed in 2003 to address lack of pediatric use information in drug labeling.


Country Life Vitamins Surveys Consumers About Healthy Aging For Ageless Theory Line Launch

 

Country Life Vitamins launches healthy aging support line as it announces less than half of US consumers in a recent survey were aware of biological processes that affect aging. Groupe Berken and Arctic Biosciences partner to bring to North America herring caviar oil extract in a supplement designed to support optimal health across all life stages.

Nozzle At Tip Of Problems For Florida Eye Drop Firm: US FDA Warns Of GMP, Monograph Violations

 

Regenerative Processing replaces nozzle to prevent backflow for its Regener-Eyes drops but FDA warning states numerous questions about sterility at the firm’s plant and about its procedures and systems for preventing microbial contamination.

EU’s Chemicals Strategy Demands Cosmetics Industry Transparency, Public Outreach

 

Cosmetics Europe’s John Chave highlights the important role that industry must have in educating the public about chemicals used in cosmetic products. The association’s COSMILE Europe database launched last year is one such measure to combat misinformation while industry braces for potential impacts resulting from new hazard categories under the Classification, Labeling and Packaging (CLP) regulation.

OcuSoft Retains Retaine Brand Name, Looks Askance At Eyeleve Marketer’s Reference

 

After launching Retaine MGD Advanced, OcuSoft says a release by Bruder Healthcare referenced Retaine MGD trademark and statements from a previous OcuSoft announcement about the original product attributed to an optometrist. B+L, Rohto brand and homeopathic firm Relief Products also make US OTC eye care space moves.