FDA Proposes Front-of-Package Nutrition Label for Most Packaged Foods
Pharmacy Times
JANUARY 17, 2025
If finalized, the requirement would include readily available nutrition information, including saturated fat, sodium, and added sugar content.
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Pharmacy Times
JANUARY 17, 2025
If finalized, the requirement would include readily available nutrition information, including saturated fat, sodium, and added sugar content.
STAT
JUNE 20, 2023
WASHINGTON — The FDA wants to make it easier for consumers to know if the foods they’re buying are unhealthy — but doing so is harder than it seems here in the United States. Now, the Food and Drug Administration is embarking on a major study to test front of package labels here in the U.S.,
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STAT
OCTOBER 7, 2022
The FDA has announced the set of rules it proposes to enforce for manufacturers to claim that a food product is “healthy.” ” The proposed rules are a lot better than the labeling anarchy that currently exists. But here’s my bottom line: health claims are not about health.
Pharmafile
APRIL 14, 2023
Pharma giant Eli Lilly’s Biologic Licence Application (BLA) for its bowel disease drug has been declined by the FDA over concerns about the proposed manufacturing of the drug. However, concerns weren’t expressed over the clinical data package, safety or label for the medicine.
STAT
AUGUST 21, 2023
A 2019 policy requires companies that make unhealthy foods to include warning labels on the front of any boxes they sell in Mexico to educate consumers about things like excess sugar and fat. MEXICO CITY — Kellogg’s is waging a war here over Tigre Toño and Sam el Tucán. Read the rest…
The FDA Law Blog
DECEMBER 8, 2022
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.,
European Pharmaceutical Review
AUGUST 23, 2022
A study of the causes of warning letters issued by the US Food and Drug Administration (FDA)’s Center for Drug Evaluation and Research (CDER) and Center for Devices and Radiological Health (CDRH) between 2010 and 2020 revealed that poor current good manufacturing practice (cGMP) compliance and misbranding were the most common citations.
European Pharmaceutical Review
JANUARY 25, 2024
Draft guidance published by the US Food and Drug Administration (FDA) in December 2023, discussed quality considerations for topical ophthalmic drug products, including key considerations for extractables and leachables (E&L) testing. Ophthalmic drug products should be evaluated for extractables and leachables, FDA asserted.
Lifewell Rx Pharmacy
JUNE 9, 2021
For example, packaging plays a vital role in promoting medication adherence. A retail pharmacy may use blister packs , Dispill®, and other types of special packages to organize prescriptions and label medications according to dosage and time of intake. Effective packaging stretches a drug’s purpose? Drug Quality.
STAT
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. Read the rest…
Roots Analysis
APRIL 20, 2022
On an average, around 50 drugs are approved by the US Food and Drug Administration (US FDA) annually. This continuously growing pipeline of pharmaceutical drug products has inadvertently led to an increase in the demand for their associated primary packaging and Secondary Packaging solutions. . trillion in 2023.
The FDA Law Blog
FEBRUARY 21, 2024
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. FDA further retained some definitions in the QSMR. Notably, Part 820 will look different. Revised § 820.3
Roots Analysis
AUGUST 26, 2024
In today’s global landscape, sustainability has emerged as a pivotal concern across various sectors including the pharmaceutical packaging industry. What is Sustainable Packaging / Green Packaging? The following figure presents the raw materials used by the sustainable packaging companies.
The Checkup by Singlecare
MARCH 10, 2025
The medication is available in both brand-name and compounded forms, although the compounded forms are not FDA approved. Some insurance plans may cover Ozempic for managing Type 2 diabetes , which is an indication that is approved by the Food and Drug Administration (FDA) to treat. Does insurance cover compounded semaglutide?
The FDA Law Blog
AUGUST 17, 2023
FDA-2023-P-0313 and FDA-2023-P-0344 ) regarding its product Hetlioz (tasimelteon). Vanda requested that FDA revoke the approval of Apotex’s and Teva’s generic versions of Hetlioz on the grounds that the generic tasimelteon products did not meet the statutory “same labeling” requirement for generic drugs found in 21 U.S.C. §
The FDA Law Blog
JULY 10, 2023
After a firm submits a 510(k) to FDA, FDA will request still more information after a first-pass review. According to the 2 nd Quarter FY2023 MDUFA V Performance Report , FDA issued a request for additional information (AI request) on the first FDA review cycle for 63% to 68% of 510(k)s submitted in FY2018 to FY2022.
The FDA Law Blog
SEPTEMBER 29, 2022
The statute itself – the National Bioengineered Food Disclosure Standard – requires use of one of three forms of disclosure: on-package text, a symbol, or an electronic or digital link. Thus, the Court concluded that addition of the standalone text message disclosure options was inconsistent with the statute’s mandate.
pharmaphorum
SEPTEMBER 15, 2022
Mallinckrodt has finally claimed FDA approval for terlipressin as a treatment for hepatorenal syndrome (HRS), after manufacturing problems scuppered an earlier attempt. The drug is already approved for this indication in dozens of other countries around the world, including much of Europe, Australia and New Zealand.
The FDA Law Blog
FEBRUARY 16, 2023
Richardson — On February 15, 2023, the Nonprescription Drugs Advisory Committee (NDAC) and the Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC) held a joint meeting to discuss an application pending before FDA that would switch Narcan (naloxone) Nasal Spray from prescription to over-the-counter (OTC) status.
pharmaphorum
FEBRUARY 23, 2022
The FDA has issued a complete response letter to Mallinckrodt for terlipressin, on the grounds that the company had been forced to change its packaging and labelling manufacturing facility for the drug. The post FDA knocks back Mallinckrodt’s kidney drug terlipressin appeared first on.
The FDA Law Blog
NOVEMBER 14, 2022
2022, FDA published a draft guidance on FDA’s implementation of the Over-the-Counter Monograph Drug User Fee Program (OMUFA). FDA is authorized to charge an annual facility fee for OTC monograph drug facilities. FDA will not refund any fees that have been incurred already). By Riëtte van Laack & Deborah L.
Pharmaceutical Technology
APRIL 14, 2023
The US Food and Drug Administration (FDA) has rejected Eli Lilly’s biologic licence application (BLA) for the ulcerative colitis (UC) drug mirikizumab over manufacturing concerns. No concerns related to the clinical data package, safety or the medicine label. The regulator has issued a complete response letter.
The FDA Law Blog
MARCH 27, 2023
Such codes need to be placed on device labels and packages to allow devices to be easily identified and tracked throughout their lifecycle, except where the rule provided for an exception or alternative. Devices can have both a UPC code and a UDI on their label and package. Most of the compliance dates have been passed.
The FDA Law Blog
JUNE 26, 2024
Lenz, Principal Medical Device Regulation Expert — FDA recently released a new eSTAR template for device pre-submissions and 513(g) Requests for Information, referred to as PreSTAR. A pre-submission provides the submitter an opportunity to obtain FDA feedback prior to a planned medical device premarket submission.
The FDA Law Blog
JULY 22, 2024
FDA Law Blog readers receive a 10% discount off the tuition fee (promo code D10-999-FDA25 ). s John W.M. Claud will be speaking at the conference in a session titled “Crafting Your Safety Blueprint for Adverse Events and Recalls under MoCRA.” You can register for the conference here.
The Checkup by Singlecare
JULY 22, 2024
It can also treat parasitic infections, like giardia, and is frequently used off-label (for a non-FDA-approved use) to help treat Crohn’s disease, bite wounds, and oral infections. Be sure to check food labels carefully for either of these ingredients. What should you eat while taking metronidazole?
pharmaphorum
OCTOBER 1, 2020
Shares in US biotech CTI BioPharma have shot up after the FDA agreed to an accelerated review early next year of its lead drug pacritinib for low blood platelets (thrombocytopenia) caused by myelofibrosis. The post CTI wins over FDA to claim early review of myelofibrosis drug appeared first on. after the announcement.
The FDA Law Blog
OCTOBER 5, 2022
By Riëtte van Laack — On September 28, 2022, FDA announced the availability of the proposed rule for the implied nutrient content claim “healthy.” The term healthy, as an implied nutrient claim, was first defined by FDA in 1994. FDA also announced it would be re-evaluating the regulatory criteria for use of the “healthy” claim.
Pharmaceutical Technology
APRIL 21, 2023
On 14 April, the FDA rejected Lilly’s biologic licence application (BLA) for their anti-interleukin (IL)-23, mirikizumab, which is in development for the treatment of ulcerative colitis (UC). The recent setback dents mirikizumab’s chances to be the first among the IL-23 inhibitors to launch in the US for UC.
The Checkup by Singlecare
JUNE 17, 2024
It’s also can be used off-label to treat morning sickness during pregnancy. Zofran vs. ondansetron The FDA withdrew Zofran oral dissolving tablets (ODT) from the market in 2023, but not due to safety or effectiveness; instead, the decision was related to packaging concerns, says Dr. Glatter. Consult a healthcare professional.
The Checkup by Singlecare
MARCH 22, 2024
Immunosuppressants are not approved by the Food and Drug Administration (FDA) specifically to treat eczema, so their use in eczema is considered off-label. Cyclosporine is FDA approved to prevent organ rejection in people who have had a liver, heart, or kidney transplant. It can also be used to treat RA.
The FDA Law Blog
SEPTEMBER 6, 2023
Food and Drug Administration – labeled an “Official Action Indicated” classification – is generally devastating for the facility, not least because it can stall FDA approval of applications to market drugs manufactured at the facility. And the Guidance may be used as leverage to secure action from FDA on a meeting request.
Pharma Marketing Network
AUGUST 9, 2023
It’s crucial for marketing teams to stay informed about the latest guidelines, policies, and updates from regulatory bodies such as the Food and Drug Administration (FDA) in the United States or the European Medicines Agency (EMA) in the European Union. Keep thorough records of approvals for future reference.
Pharmaceutical Technology
NOVEMBER 30, 2022
These contracts involve the manufacturing of biological and small molecule active pharmaceutical ingredients (APIs), parenteral manufacturing and packaging, and other manufacturing-related tasks. Also in September, the US FDA expanded Sanofi / Regeneron Pharmaceuticals’ Dupixent (dupilumab) label to include prurigo nodularis.
The Checkup by Singlecare
OCTOBER 9, 2023
When dosing children’s Benadryl , always use the dosing cup or device included in the package.” If you are giving your child any other cold or other allergy medication, especially combination formulas, check the labels and discuss with your child’s healthcare provider to avoid interactions.
The FDA Law Blog
JANUARY 3, 2024
Enter the FDA’s Center for Veterinary Medicine (“CVM”). A longstanding component of the FDA and its predecessor, CVM, in its initial form as part of the Department of Health, Education, and Welfare, was established in 1965 and evolved in CVM by 1984.
The Checkup by Singlecare
MARCH 22, 2023
We have a regulator called Health Canada, similar to the Food and Drug Administration (FDA), which works to ensure the safety of our drugs,” Tadrous says. The FDA allows customers to purchase drugs from Canadian online pharmacies and have them shipped to the U.S. If you don’t live near the border between the U.S. Are not licensed.
The 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.
pharmaphorum
JUNE 15, 2022
Manufacturing problems wreaked havoc with Mallinckrodt’s first attempt to secure FDA approval of its treatment candidate terlipressin for hepatorenal syndrome (HRS), but the drugmaker is having another attempt. There is no FDA-approved therapy available.
The Checkup by Singlecare
AUGUST 8, 2024
She also explains that “Zyrtec’s use for dogs is ‘ off-label.'” Check the drug’s packaging and label carefully before giving it to your pet. The FDA says Zyrtec’s effects typically last around 24 hours for humans, and studies show that its elimination half-life is around 8.3
The Checkup by Singlecare
JANUARY 4, 2024
Always follow the directions on the packaging or consult a healthcare professional if you have concerns about the appropriate dosage. In addition, the FDA label for the nighttime forms of Mucinex containing acetaminophen recommends avoiding three or more drinks per day.
The People's Pharmacy
JUNE 12, 2023
If a patient wants to report an adverse reaction to the FDA, they need to fill out Form 3500B. It is rare for pharmacies to put the expiration date on the label if they transfer the pills from the manufacturer’s original container. After all, computers easily generate a date one year from the dispensing day when printing the label.
The Checkup by Singlecare
JULY 11, 2024
The drug’s label recommends doses of 5–60 mg per day. Food and Drug Administration ( FDA ), some common side effects include: Headache Nausea Increased appetite Trouble sleeping Weight gain Fatigue Fluid retention Acne Prednisone may also cause certain serious side effects. “If Is colchicine or prednisone better for gout?
The Checkup by Singlecare
DECEMBER 29, 2023
Because Zyrtec causes sleepiness, the most concerning drug interactions involve drugs that also cause sedation, such as: Other antihistamines Tranquilizers Opioids Benzodiazepines Gabapentin General anesthetics Alcohol Cannabis Safety measures while using Zyrtec What are the FDA warnings about Zyrtec? Who should never take Zyrtec?
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