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Identify your manufacturing partner early!

At FDA Compliance Simplified we enjoy working with companies of all sizes. Some of our clients are brand owners but not manufacturers.  They team with contract manufacturers to produce shelf-ready products. This can sometimes make it hard to get the information we need to ensure [...]

2023-12-05T22:29:55-07:00December 5, 2023|

Delay of Enforcement for Cosmetic Registration and Listing

November 8, 2023, FDA announced  that the enforcement date for cosmetic facility registration and product listing will be delayed until July 1, 2024. The announcement stated that this was "to provide regulated industry additional time to comply with these requirements." However, the guidance document itself [...]

2023-11-08T12:57:11-07:00November 8, 2023|

Private Labeling for Retail Expansion

FDA Compliance Simplified is privileged to help companies of all sizes and from all over the globe achieve compliance with FDA regulations.  Many are referred to us by existing customers, some find us online, and other come to us through quality service providers that help [...]

2023-11-06T13:47:58-07:00November 6, 2023|

Major Cosmetic Regulation Revamp

Major Cosmetic Regulation Update March 27, 2023 - FDA Has Stopped Accepting Submissions to the Voluntary Cosmetic Registration Program FDA issued an update today stating that they are no longer accepting voluntary cosmetic establishment registration and that information in the VCRP will not be transferred [...]

2023-03-27T12:33:17-06:00January 23, 2023|

Time to Renew FDA Facility Registrations

The Food and Drug Administration (FDA) requires registration of manufacturing warehousing facilities for most product categories under the agency’s jurisdiction. This is true for food, dietary supplement, pet food, animal feed, drug, medical device, and biologic facilities.  The only exception is the cosmetic sector; registration [...]

2022-12-19T09:18:19-07:00December 5, 2022|

Are Your Test Methods Scientifically Valid?

A respected colleague, Marian Boardley, recently published a blog post that is important for anyone in the dietary supplement industry. I’d like to share some highlights with you. Ms. Boardley frequently evaluates FDA data on inspections and shares her insights.  In her recent post she shared a table [...]

2022-12-01T15:42:58-07:00November 7, 2022|

Proposed New Definition of Healthy for Food Label Claims

The FDA has proposed a new definition of healthy and related terms for the purpose of food labeling.  The current definition became effective in 1994 and focuses on limited levels of total fat, saturated fat, cholesterol, and sodium to establish a food as “healthy”.  Under [...]

2023-03-28T18:27:28-06:00October 18, 2022|

Letter on proposed changes to GRAS regulations

There is a bill before the Senate Committee on Health, Education, Labor, and Pensions that would drastically alter the path to market for new food ingredients.  As an observer of FDA, I expect that this bill will have ramifications for the dietary supplement industry and the New Dietary Ingredient Notification process. 

2022-11-01T16:36:09-06:00June 13, 2022|

New for 2022! Bioengineered Food Labeling

Update February 17, 2022: Please use this link to view the UNPA webinar "In the BEginning"... Dietary Supplements Supply Chain Starts with Ag mentioned in the original post. The webinar opens with a general introduction and the presentations begin as indicated below. Good Agricultural and [...]

2022-08-26T09:34:00-06:00January 31, 2022|

Voluntary Sodium Reduction Targets for Foods

Many of you will recall that the 2016 updates to food nutrition labeling included a lower percent daily value for sodium (2300 mg/day).  Along with that, the update proposed that there should be a gradual reduction in sodium levels.  Last week FDA published a final [...]

2022-08-26T09:34:00-06:00October 25, 2021|

2020 in Review

The year 2020 started out ordinarily enough for the FDA Compliance Simplified team.  We had projects related to foods, dietary supplements, over the counter drugs (OTC), pet foods, and medical devices.  On March 2nd we received our first call regarding a project related to the new virus that was beginning to affect the United States.

2022-08-26T09:34:00-06:00January 3, 2021|

Prop 65 for FDA-regulated Products

Helping companies comply with FDA regulations is our specialty.  But FDA is not the only regulatory body our clients need to be aware of.  As our readers know, from time to time we invite other experts to provide other regulatory information essential to market success [...]

2022-08-26T09:34:00-06:00December 14, 2020|

FDA and COVID-19

FDA has issued new policies affecting the food, dietary supplement, drug, and medical device industries in response to the COVID-19 pandemic.

2022-08-26T09:34:00-06:00March 24, 2020|

Are you CBD curious?

We are based in Colorado, a state that has legalized both medicinal and recreational marijuana use.  Colorado's industrial hemp farming program was initiated through legislation adopted in 2013. On the national scene, passage of  the 2018 Agriculture Improvement Act removed hemp from the controlled substance [...]

2022-08-26T09:34:01-06:00August 6, 2019|
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