Monthly Newsletter February 2023

NDI Draft Guidance Image

Bad Boys, Bad Boys, what you gonna do? What you gonna do when FDA comes for you?

This year brings renewed speculation about the largely anticipated news of the FDA fiiiiinally enforcing NDI Notifications. While the NDI draft guidance is still making its way through the rule making process, the FDA is on record that they’ve been hunting and have found numerous potential violators. So they have a hit list of sorts. Are you on it? How do you find out? Contact us to help. Real question becomes, will they wait until the guidance is finalized or will they just carry on as if it were? Another question, more importantly, what are they going to actually do about it? Uneven enforcement seems to be a never-ending theme with the Agency, and publicly shaming violators with Warning Letters or encouraging “voluntary” recalls just doesn’t cut it to have a wide enough and timely impact. There are other tools at their disposal, but will they use them or just keep punting and hope the industry resolves everything itself? Because that has worked out so well. Hmmmmmmmm. Read More

Enhanced Label Reviews & Remediation

Top tier reviews of your dietary supplement, food, or beverage labels to ensure accurate and compliant with industry regulations and claims. Label and packaging artwork modification or builds based on the most in-depth and regulatory specific reviews available. Learn More

Litigation Consulting & Expert
Witness Services

We provide critical investigation, litigation support and expert witness services for legal matters involving product testing, contaminations, recalls, labeling and claims, contractual breaches, whistle blower matters and much more… Learn More

Product Complaint
Investigations & Closing

Ensure compliance of your Product Complaint handling practices with efficient evaluations and investigations through to close out for your dietary supplements, foods, or beverages. Don’t just log them, close them and protect your brand. Learn More

Other Updates

We’re adding more show to the schedule with a number of team members attending various national and international trade shows coming up…can we schedule a time to connect?

•  February 15th 2023 – Sports & Active Nutrition Summit
•  February 16th 2023 – Annual Plant-Based Foods & Protein Summit
•  March 7th 2023 – Expo West 2023
•  April 28th 2023 – Conference for Food Protection
•  May 9th 2023 – Vitafoods Europe