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Labeling, perhaps the most looked-after section of any product; either a medicinal product, medical device or a cosmetics product. As it furnishes the first-hand information about the product to the outside world, Life Sciences manufacturers across the globe are obliged to manage this piece of information as accurately as possible to win the end-user’s trust.
In the European Union (EU), a cosmetic marketing claim is regulated under EU Regulation (EC No. 655/2013). The Annex III – ‘free from’ claims were added on the July 3, 2017 to the list of regulations to be effective/mandated from July 1, 2019. At the same time the Annex IV ‘hypoallergenic’ claim was introduced.
More than ever, consumers these days are concerned about their personal health and well-being and are keen on looking for informative product labels for correct usage. This has given rise to several trends in the food labeling industry.
In January 2006, the United States Food and Drug Administration (US FDA) introduced Structured Product Labeling (SPL) format for submitting product and facility information and changes to label submissions. The shift towards the new electronic format was aimed at uniformly informing patients, physicians, pharmacists, and the agency about the label content.
On May 27, 2016, the United States Food and Drug Administration (US FDA) published the final rule for nutrition and supplement facts label in the Federal Register. The final rule ensures that the label reflects new scientific information including the link between diet and chronic diseases like obesity and heart disease.
The life sciences industry is ever-changing and evolving. It’s the same in the year 2018. A lot of mandatory changes have been made to the regulations, and a lot of guidance documents have been released pertaining to the best Regulatory practices of consumer healthcare, medical devices, pharmaceuticals, which are expected to impact the industry in a positive way.
The National Health Regulatory Agency (ANVISA) of Brazil, on 22 November 2018, published a new standard - Resolution RDC 250/2018 related to the Official Gazette of the Union. The new resolution, related to Cosmetics labeling, was passed to enhance the agility of the cosmetics sector in Brazil and reduce the cost of labeling processes to the organizations.
Be it a drug, device, cosmetic or food product, it is essential to convey the product information with respect to its usage, indications, warnings and other crucial aspects that are informative and beneficial to the end-user.
Lack of clarity on indications and uninformed usage of drugs and biological products may lead to unforeseen adversities, which might in turn affect manufacturers / sponsors through financial penalties and legal actions.
The United States Food and Drug Administration’s (USFDA’s) Pregnancy, Lactation and Labeling Rule (PLLR), which came into effect in June 2015, establishes a labeling standard for prescription drug products which can be used during maternity and lactation.
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