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FDA Issues Two Guidance Documents on Food Allergen Labeling Requirements

The FDA Law Blog

Food and Drug Administration (FDA) issued two guidance documents, one draft and one final, on food allergen labeling requirements. 1, 2023; The applicability of food allergen labeling requirements to specific products (e.g., 1, 2023; The applicability of food allergen labeling requirements to specific products (e.g.,

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Parallel import of medicinal products: regulatory update

European Pharmaceutical Review

This concerns the quantity of the medicinal product in the packaging, ie, the increase or decrease in the number of units of the product in the outer packaging according to local demands and its labelling, including the leaflet, which should be in the language of the country into which the product is imported.

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FDA Issues Long-Awaited QMSR Final Rule

The FDA Law Blog

Both ISO 13485 and ISO 9000 contain terms and definitions that are referenced within Part 820. FDA further retained some definitions in the QSMR. FDA further retained some definitions in the QSMR. Certain definitions are also removed from § 820.3, Revised § 820.3 Subpart B reserves §§ 820.20 – 820.30, 820.40.

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FDA Publishes Proposal to Redefine the Implied Nutrient Contain Claim “Healthy” Changing Focus to Foods Rather than Nutrients Adding Limits on Added Sugar Content

The FDA Law Blog

In 2015, FDA issued a Warning Letter to Kind LLC because, among other things, the company labeled products as healthy whereas these products provided more saturated fat per serving than permitted by the regulatory definition. FDA also announced it would be re-evaluating the regulatory criteria for use of the “healthy” claim.

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6 foods to avoid while taking MiraLax

The Checkup by Singlecare

It has several off-label uses, too, including treating chronic constipation, constipation related to irritable bowel syndrome (IBS), bowel preparation for colonoscopy procedures, and treating constipation in children (which the American Academy of Pediatrics considers safe). Follow the dosing instructions on the package and be patient.

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Pet Food Institute Proposes Modernization of Pet Food and Treats Regulation

The FDA Law Blog

The Federal Food, Drug, and Cosmetic Act (FDC Act) requires that all animal foods, like human foods, be safe to eat, produced under sanitary conditions, contain no harmful substances, and be truthfully labeled. AAFCO also publishes model regulations, including model pet food labeling regulations which states may adopt.

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Best allergy medicine for a runny nose

The Checkup by Singlecare

However, the FDA has not yet arrived at a definite conclusion as the evidence is still under review. They’re effective, but don’t give immediate relief—it usually takes a few days to feel better,” Following the recommendations for use written on the package insert is important. For instance, some antihistamines can trigger drowsiness.