XTalks

JUNE 22, 2023

The Rethink Plastic alliance, in collaboration with a coalition of 81 organizations, is advocating for the integration of effective reuse systems into the European Union’s (EU’s) Packaging and Packaging Waste Regulation. This push aims to mitigate waste produced by single-use plastic takeaway packaging.

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STAT News

DECEMBER 23, 2022

trillion omnibus spending package that includes numerous provisions aimed at addressing the opioid epidemic. These highly regulated facilities are made up of multidisciplinary teams of physicians, nurses, counselors, and social workers who provide comprehensive medication-assisted treatment. Congress is expected to pass a massive $1.7

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XTalks

JANUARY 31, 2023

The US Department of Agriculture (USDA) recently updated its organic food regulations to tighten guidelines around organic products. However, products labeled “organic” may contain five percent non-certified organic materials. Related: Are Best Before Dates on Food Packaging to Blame for Food Waste?

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STAT News

OCTOBER 19, 2022

After years of deliberation, the FDA recently announced a new set of rules it proposes to regulate claims on food packaging that a product is “healthy.” ” The most basic rule: the product must actually contain food, not just ingredients.

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FDA Law Blog

JUNE 12, 2023

By Riëtte van Laack — FDA regulates pet food similar to other animal foods. 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.

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XTalks

SEPTEMBER 24, 2020

Despite our best efforts to avoid added chemicals, the food and beverages we consume likely contain one or more of some 10,000 chemicals allowed to be added to foods. In terms of the potential harms of food additives and packaging, synthetic chemicals that affect hormones have additive or synergistic effects.

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FDA Law Blog

MARCH 6, 2022

Mullen — On February 23, 2022, FDA published in the Federal Register a proposed rule that would replace the Quality System Regulation (QSR), at 21 C.F.R. Part 820, with a newly named Quality Management System Regulation (QMSR). ISO 13485, while largely duplicative to the QSR, is not a perfect fit with other existing FDA regulations.

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XTalks

JANUARY 17, 2023

The US Food and Drug Administration (FDA) has added sesame to its list of major allergens, making it easier for people with sesame allergies to safely consume packaged food without fear of an allergic reaction. So probably the biggest change for us on our packaging labels is we have to redo all that and add sesame.”.

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Pharmaceutical Technology

MARCH 10, 2023

The document contains detailed information on the suppliers and their product offerings, alongside contact details to aid your purchasing decision. Role of freeze-drying systems in the pharmaceutical industry The pharmaceutical freeze-drying market is highly governed by stringent standards and laws.

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FDA Law Blog

JULY 17, 2022

Kirschenbaum — Last November, we blogged about a provision of the Infrastructure Investment and Jobs Act that requires new rebates for discarded amounts of drugs that are covered under Medicare Part B, and that are packaged in a single-dose container or single-use package. million).

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FDA Law Blog

OCTOBER 31, 2021

SB 343 adds additional requirements; it requires that California’s Department of Resources Recycling and Recovery (CalRecycle) update regulations that require disposal facilities to provide information on recycling data. g)(4) of the California Public Resources Code; or. Finally, SB 343 provides that resin identification code numbers (e.g.,

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XTalks

NOVEMBER 25, 2021

is recalling four lots of its injectable seizure medication levetiracetam over concerns of container closure integrity on vials of the drug product. The levetiracetam injection (USP 500 mg per 5 mL) is packaged in a single-dose 5 mL vial. The integrity of container closures is critical to drug safety. Sagent Pharmaceuticals Inc.

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XTalks

JANUARY 26, 2023

The US Food and Drug Administration (FDA) has added sesame to its list of major allergens, making it easier for people with sesame allergies to safely consume packaged food without fear of an allergic reaction. Identifying which foods contain sesame is an important step in food safety and health care as an estimated 0.2

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FDA Law Blog

OCTOBER 5, 2022

The proposed rule is intended to align with current nutrition science, the Dietary Guidelines for Americans 2020-2025 and the 2016 nutrition labeling regulation (which also was intended to align with the Dietary Guidelines for Americans). This information is not included in the proposed codified language for the regulation.

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XTalks

JANUARY 29, 2024

Although the medical device industry is dedicated to advancing healthcare innovation, pursuing environmental responsibility has encountered obstacles mainly due to rigorous regulations. Coloplast is focused on improving its products and packaging vis-à-vis reducing emissions.

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FDA Law Blog

FEBRUARY 21, 2024

By Véronique Li, Senior Medical Device Regulation Expert & Ana Loloei & Allyson B. Mullen — More than five years after FDA first announced its plan to harmonize 21 CFR Part 820 with ISO 13485, on February 2, 2024, FDA finally issued the Quality Management System Regulation (QMSR) Final Rule. The new § 820.10 Revised § 820.3

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XTalks

JULY 27, 2022

Yet over the past few weeks, she’s faced numerous questions about Pink Sauce’s ingredients, packaging and marketing, prompting a social media-based food scandal. He showed the bottle label that seemed to indicate that it contains 444 servings of the product, at 60 calories per serving of about a tablespoon — a near mathematical impossibility.

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FDA Law Blog

MARCH 21, 2024

As readers of our blog know, MoCRA was a significant change to regulation of cosmetics. Now in the second year of implementation, companies have started noticing the consequences as FDA implements the new requirements and develops regulations and guidance.

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FDA Law Blog

AUGUST 19, 2021

The latest version of the bill again directs FDA to establish a standard symbol system for front-of-package labeling for conventional foods. Regulation to establish levels of allulose, polydextrose, sugar alcohols or isolated fibers above which require a warning that the food contains levels that cause “deleterious health effects.”.

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XTalks

NOVEMBER 1, 2024

This oven’s AI-driven features also offer insights into temperature regulation and nutrient preservation. Sustainable Packaging Solutions Bell Bowls’ Clamshell To-Go Container: Biodegradable Takeaway Bell Bowls tackles single-use waste with a biodegradable clamshell container, crafted from sugarcane-based material.

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FDA Law Blog

SEPTEMBER 29, 2022

Plaintiffs challenged the use of the term bioengineered (rather than GMO or genetically engineered), the limitation of the mandatory disclosure being required only if the food contains detectable modified genetic material and the options of using a QR code disclosure or a text message for the disclosure statement.

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XTalks

DECEMBER 7, 2023

In the US, the regulation of food products, including the ban on certain items, falls primarily under the jurisdiction of two key agencies: the US Food and Drug Administration (FDA) and the US Department of Agriculture (USDA). In this episode of the Xtalks Food Podcast, Sydney talks about the top 10 foods banned in the US and why.

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XTalks

SEPTEMBER 13, 2022

The meal kits containing ground beef for this public health alert were shipped to consumers from July 2-21, 2022,” the FSIS stated in a public health alert. plastic vacuum-packed packages containing ‘GROUND BEEF 85% LEAN/15% FAT’ with codes ‘EST#46841 L1 22 155’ or ‘EST#46841 L5 22 155’ on the side of the packaging.”. “The

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XTalks

AUGUST 31, 2020

Importation of contaminated food and food packaging is a feasible source for such outbreaks and a source of clusters within existing outbreaks,” according to the study’s abstract. And Vietnam, a country that had won praise for its aggressive measures in containing the virus, suffered scores of infections and ten deaths in August.

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XTalks

APRIL 11, 2024

As a staple spice in many kitchens, the discovery of elevated lead levels in cinnamon products has prompted a closer look at food safety practices and regulations. Additionally, the processing of cinnamon, including drying, grinding and packaging, can introduce lead if the equipment or materials are contaminated.

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XTalks

AUGUST 12, 2020

Terms like ‘multigrain,’ ‘contains whole grains,’ ‘honey wheat’ and ‘12-grain’ can be used to tout breads, cereals and crackers as healthier options even if the product mostly contains refined flour, explained lead researcher Parke Wilde, a professor at Tufts University’s School of Nutrition Science and Policy in Boston.

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XTalks

FEBRUARY 13, 2024

Starbucks Refreshers: Fruitful Imagery without the Fruit Starbucks faced criticism and legal action with its Refreshers lineup, accused of misleading consumers by suggesting that the drinks contained real fruit corresponding to their names, when in fact, they did not.

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XTalks

NOVEMBER 2, 2021

They obtained 64 samples of hamburgers, fries, cheese pizza, chicken burritos and chicken nuggets from various chains and found that over 80 percent contained the phthalate di-n-butyl phthalate (DnBP), while 70 percent contained di(2-ethylhexyl) phthalate (DEHP), both of which have been linked to reproductive health issues.

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FDA Law Blog

JANUARY 3, 2024

Specifically, CVM ensures that animal drugs are safe and effective, properly made, and adequately labeled and packaged; food-producing animals only take drugs that would be safe for humans to consume; pet foods and additives are safe; and educates the public, monitors the market, and encourages development of new animal health products.

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FDA Law Blog

SEPTEMBER 30, 2024

Gaulkin — In May 2023, we posted about a CMS proposed regulation that sought to make a wide variety of changes to the Medicaid Drug Rebate Program (MDRP), including a new “price verification survey,” and a controversial proposal to require “stacking” of discounts to different customers when determining best price.

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XTalks

AUGUST 25, 2023

In the US, the primary agency responsible for regulating allergen labeling on food products is the US Food and Drug Administration (FDA). Xtalks spoke to Betsy Craig, CEO and founder of MenuTrinfo, to find out how the company certifies products and where government regulations fall short. We go to the facility.

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Camargo

NOVEMBER 15, 2021

In October, the FDA took a step towards clarifying these questions with a guidance called “ Data Standards for Drug and Biological Product Submissions Containing Real-World Data.”. The guidance also contains some useful information, despite the limitations described above. Batch steps include filter drying, milling, and packaging.

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XTalks

DECEMBER 20, 2021

Last Friday, The Coca-Cola Company issued a recall of some of its beverages because the affected products may contain pieces of metal bolts, washers or other foreign objects. Both the Minute Maid and Coca-Cola beverages are set to expire in 2022, which means consumers might still have products that contain the unspecified contaminants.

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FDA Law Blog

MARCH 8, 2023

By Véronique Li, Senior Medical Device Regulation Expert — On March 17, 2023, enhancements to FDA’s electronic Medical Device Reporting (eMDR) system will go live. For any major changes, additional time will be granted between the release of the implementation package and production deployment.

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XTalks

NOVEMBER 9, 2022

However, ultra-processed foods contain more artificial ingredients than those that just have added salt, sugar or oil. They usually have very few whole ingredients and contain flavorings, colorings or other additives.

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XTalks

NOVEMBER 11, 2021

On menus and food packaging, it is not uncommon for vegan chicken to be called “chicken,” since the names that are given to different foods are merely approximations of what they are. Even if the word is followed by “vegan” or “plant-based,” meat producers believed there should be alternative names for foods that don’t contain meat.

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Advarra

JULY 19, 2022

The standard for the audit used depends on the type of vendor and would include the applicable regulations and ICH guidelines. Q: What is the typical time period between the submission of the briefing package and the pre-IND meeting? The term drug substance and drug product are found in the NDA regulations 21 CFR 314.3,

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