FDA Law Blog

DECEMBER 8, 2022

Most notably, the draft guidance clarifies that the following food products are subject to the allergen labeling requirements: Bulk containers (e.g., Most notably, the draft guidance clarifies that the following food products are subject to the allergen labeling requirements: Bulk containers (e.g.,

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Genetic Engineering Containment Cosmetics Protein 59

XTalks

NOVEMBER 17, 2022

She explains that 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. The team wonders why Red 3 is allowed in food but not in cosmetics.

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Cosmetics Containment Scientist Drugs 52

XTalks

JUNE 5, 2023

Ozempic and Wegovy, which contain the active ingredient semaglutide, were approved by the US Food and Drug Administration (FDA). During a drug shortage, compounders might be allowed to prepare a compounded version of the drug provided they meet specific requirements of the Federal Food, Drug, and Cosmetic (FD&C) Act.

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FDA Approval Containment Drugs Pharmacy 98

World of DTC Marketing

JUNE 6, 2021

Wegovy also contains warnings for pancreatitis, gallbladder problems including gallstones, low blood sugar, acute kidney injury, eye retina damage, increased heart rate, and suicidal behavior or thinking. And, like any medication, there is a risk of side effects, some serious.

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Drugs Cosmetics Production FDA Approval 318

The Pharma Data

NOVEMBER 8, 2020

We are very pleased to announce the achievement of two key milestones in our strategy to pursue specific clinical indications that will enable us to market and sell Renuvion ® for target procedures in the cosmetic surgery market,” said Charlie Goodwin, President and Chief Executive Officer.

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FDA Law Blog

MAY 23, 2023

the product label declares “tree nut” or “fish” but fails to declare the type of tree nut or species of fish in either the ingredient list or in a separate “Contains” statement). The draft CPG directs FDA field staff to examine possible food product adulteration due to labeling related to allergen cross-contact.

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XTalks

SEPTEMBER 28, 2023

Parabens, which are also prevalent in cosmetics, can interfere with the regular operation of human hormonal systems, affecting both male and female reproductive health, development, fertility and birth results. Citrus-flavored beverages are particularly prone to containing BVO. BVO tends to accumulate in the human body.

Hormones 52

Hormones Containment Production Cosmetics 52

FDA Law Blog

JUNE 17, 2021

Under section 502(ff) of the Food, Drug, and Cosmetic Act, a drug that is manufactured at a facility for which required OMUFA fees have not been paid is deemed misbranded. The list includes several hundred facilities running over 70 pages.

Cosmetics 52

Cosmetics Manufacturing Containment Drugs 52

FDA Law Blog

JULY 13, 2021

The mandatory disclosure requirement of the BE standard applies to human food, including dietary supplements, that is subject to the labeling requirements under the Federal Food, Drug, and Cosmetic Act, as well as some products under the jurisdiction of the USDA’s Food Safety and Inspection Service.

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Compliance Cosmetics Regulation Manufacturing 52

XTalks

NOVEMBER 28, 2023

They are banned because they contain non-edible items, posing a risk, particularly to children. Under the provisions of the 1938 Food, Drug, and Cosmetic Act, Kinder Surprise eggs are classified as “adulterated food,” rendering their importation and sale illegal. ” Consequently, this dish is seldom served in the US.

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Sales Regulation Containment Production 52

FDA Law Blog

AUGUST 19, 2021

The addition of “gluten-containing grain” when referencing food allergens, and the addition of “gluten-containing grain” to FSMA’s Hazard Analysis and Preventive Controls, as well as to food allergen inspections language. Defining the term “natural.”. A study on the fortification of corn masa flour.

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Regulation Containment Cosmetics Packaging 52

FDA Law Blog

JULY 11, 2023

Koblitz — One of the most important questions FDA has to answer is whether a given product is appropriately characterized as a drug, biologic, device, food, cosmetic, or something entirely different. As we have explained before , that distinction is critical to assigning a particular product to the appropriate regulatory scheme.

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Protein Production Regulation Cosmetics 95

FDA Law Blog

JUNE 28, 2023

ASCA was authorized under section 514(d) of the Federal Food, Drug, and Cosmetic Act (FD&C Act). 2022 Device Submissions with ASCA Testing According to the ASCA 2022 Annual Report , the “FDA received five submissions that contain ASCA testing: four with basic safety and essential performance testing and one with biocompatibility testing.

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Containment Radiology Cosmetics Manufacturing 52

Advarra

JULY 26, 2022

Cannabis plants and derivatives containing no more than 0.3% Importantly, the 2018 Farm Bill preserved FDA authority to regulate products with cannabis or cannabis-derived compounds under the Federal Food, Drug, and Cosmetic (FD&C) Act and Section 351 of the Public Health Service Act.

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Regulation Research Production Cosmetics 97

Pharma in Brief

JANUARY 7, 2024

Section 804 Importation Programs On October 1, 2020, the FDA published a rule entitled Importation of Prescription Drugs (the US Importation Rule ) to implement Section 804 of the Food, Drug, and Cosmetic Act.

Drugs 52

Drugs Regulation FDA Approval Manufacturing 52

FDA Law Blog

AUGUST 4, 2023

DASCA amended the CSA by revising and adding specified substances to the definition of “anabolic steroid,” providing for the temporary and permanent scheduling of anabolic steroids and adding labeling requirements for products containing anabolic steroids. DASCA became law, amending the CSA, on December 18, 2014.

Hormones 52

Hormones Manufacturing Regulation Drugs 52

FDA Law Blog

APRIL 12, 2022

This document contains a number of legislative proposals, including three proposed amendments to the accelerated approval statutory provisions in section 506(c) of the Federal Food, Drug, and Cosmetic Act. Torrente — On March 28, 2022, FDA transmitted its justification to Congress for its Fiscal Year 2023 budget.

Cosmetics 52

Cosmetics Drugs Containment Development 52

FDA Law Blog

JANUARY 1, 2024

Patcos Cosmetics Pvt. of Brooklyn, NY (sildenafil in a product marketed as a dietary supplement; [link] Botanical Be of El Paso, Texas (“Kuka Flex Forte” and “Reumo Flex,” marketed as dietary supplements, contain diclofenac; Warning Letter ; and com, Inc., of Mumbai, India, was criticized for many of the same issues.

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Manufacturing Production Drugs FDA Compliance 59

XTalks

JANUARY 5, 2024

Along with the launch of LillyDirect this week, Lilly also issued an open letter recommending that Zepbound and Mounjaro not be used for “cosmetic weight loss.” An independent tool is available for patients to locate and connect with healthcare professionals nearby for in-person care if they prefer.

Drugs 59

Drugs Pharmacy Cosmetics Insulin 59

XTalks

NOVEMBER 24, 2022

According to the warning letters, these products are considered adulterated under “section 402(a)(2)(C)(i) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), 21 U.S.C. 342(a)(2)(C)(i), because they bear or contain an unsafe food additive. 331(ll) and 331(a).”.

Production 52

Production Branding Cosmetics Marketing 52

Roots Analysis

AUGUST 15, 2023

Additionally, these types of cell free systems do not contain proteases and nucleases as crude cell lysates, which further helps in improving the production of many proteins. Such systems provide control over the components used for the synthesis of target products making it easier to manipulate the contents according to specific needs.

Protein 52

Protein In-Vitro Production Reagent 52

Camargo

NOVEMBER 15, 2021

The 21 st Century Cures Act generated a good deal of excitement and interest when it added a section called “ Utilizing Real World Evidence ” to the Food, Drug, and Cosmetic Act (Section 505F). The guidance also contains some useful information, despite the limitations described above.

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FDA Law Blog

APRIL 19, 2023

Module 5 should also include information about safe nonprescription marketing and use if the proposed drug contains an active ingredient not previously contained in certain OTC monographs or orders, and any postmarketing safety information.

Containment 59

Containment Drugs Cosmetics Marketing 59

The Pharma Data

DECEMBER 30, 2020

that may contain potentially fatal levels of aflatoxin. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products. This is an ongoing investigation. SOURCE U.S.

Production 52

Production Cosmetics Compliance Containment 52

The Pharma Data

FEBRUARY 18, 2022

The FDA is advising consumers not to use Similac, Alimentum, or EleCare powdered infant formulas if: the first two digits of the code are 22 through 37; and the code on the container contains K8, SH or Z2; and the expiration date is 4-1-2022 (APR 2022) or later. and were likely exported to other countries. Source link: [link].

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The Pharma Data

MARCH 7, 2022

Today’s decision underscores our commitment to using a risk and science-based, data-driven process that focuses on safety to the animals containing intentional genomic alterations and safety to the people who eat the food produced by these animals,” said Steven M. Solomon, D.V.M., director of the FDA’s Center for Veterinary Medicine.

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FDA Law Blog

MAY 3, 2023

The initial group posted also included the administrative order containing a list of certain active ingredients offered for certain OTC uses FDA had found to be non-monograph conditions (former 21 CFR § 310.545).

Regulation 59

Regulation Containment Production Drugs 59

Camargo

DECEMBER 13, 2021

Both the FDA’s Center for Drug Evaluation and Research (CDER) and its Center for Biologics Evaluation and Research (CBER) have regulatory responsibility for therapeutic biological products, which are subject to both the Federal Food, Drug and Cosmetic (FD & C) Act and the Public Health Service (PHS) Act.

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FDA Law Blog

OCTOBER 17, 2021

Perhaps one day those numbers will be as familiar as references to the various parts of the CFR containing the monographs (maybe). We here at HPM hope that FDA will continue to maintain the webpage Status of OTC Rulemakings which contains easily accessed historical information and links. For each OTC monograph title (e.g.,

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Containment Drugs Production Cosmetics 52

The Pharma Data

NOVEMBER 29, 2021

The use of folate, folic acid, or folate-containing supplements should be avoided within 48 hours before administration of Cytalux. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

FDA Approval 52

FDA Approval Drugs Cosmetics Protein 52

FDA Law Blog

MARCH 13, 2024

Part 2 (“Part Deux”) investigated the PTO’s position and recent decisions on PTE applications for patents covering products approved—and then withdrawn years later—under the Federal Food, Drug, and Cosmetic Act’s Accelerated Approval provisions (and otherwise). Do you really have to identify both “Grants” to be correct?

Marketing 59

Marketing Production FDA Approval Generic Drugs 59

XTalks

APRIL 26, 2021

The marker may soon be found on food and beverage products, pet food, dietary supplements, cosmetics and more. From the images on its website , it appears as though there is a regular marker and one that informs consumers that the product contains minimal upcycled content, or less than ten percent.

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FDA Law Blog

NOVEMBER 9, 2021

115-521 ) amended Section 745(A)(b) for the Federal Food, Drug, and Cosmetic Act (FD&C Act) to include that after publication of a final guidance, pre-submissions and 510(k)s “shall be submitted solely in such electronic format as specified by the Secretary in such guidance.” Draft Guidance at 8.

Containment 40

Containment Cosmetics Packaging Packaging 40

The Pharma Data

MARCH 15, 2022

This drug-device combination product is a metered-dose inhaler (MDI), which contains both budesonide (a corticosteroid that reduces inflammation) and formoterol (a long-acting bronchodilator that relaxes muscles in the airways to improve breathing). Source link: [link] ov/.

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FDA Law Blog

APRIL 25, 2023

A recent amendment to the Federal Food, Drug, and Cosmetic Act (FD&C Act) added a new section about cybersecurity for “cyber devices.” By Philip Won & Jeffrey K. Shapiro — Does your firm manufacture a “cyber device”?

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Regulation Cosmetics Production Manufacturing 105

The Pharma Data

DECEMBER 4, 2021

Avoid skin products that may dry or irritate your skin such as medicated or harsh soaps, astringents, cosmetics that make your skin dry, and products containing high levels of alcohol, spices, or limes. Avoid applying Adapalene and Benzoyl Peroxide gel to cuts, abrasions, and sunburned skin.

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Doctors Doctor Medicine Production 52

The Pharma Data

NOVEMBER 4, 2020

Ltd (“Juyou”), a biotechnology company that develops and sells medical and cosmetic skincare products, for the commercialization and development of Pliaglis ® in mainland China (the “License Agreement”). For additional information, please visit www.crescitatherapeutics.com.

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