Regulatory Compliance Programs

Regulatory compliance programs are ultimately intended to protect consumers from harmful products. Likewise, they help ensure a safe environment for those who manufacture your product. Without regulatory compliance programs, we’d be living in the wild West when it comes to food and nutraceutical safety.

In short, it can be if you are not prepared. FDA inspection is a critical step for many small businesses hoping to market a food or nutraceutical product. Passing FDA inspection is a multifaceted process with many moving parts. Kurt C Schneider, CFS has over 30 years of experience helping businesses like yours to pass FDA inspection. Call Kurt at 714.657.8508 for a no-obligation consultation.

To put it simply, if the section has the phrase ‘Must Have’ then you need to comply with the strict letter of that section. Failure to do so constitutes a non-compliance during an inspection which can result in failing the inspection. Thew phrase ‘Should Have’ is the government’s way of saying ‘you should have this in your quality program but you won’t be marked down during an inspection if you don’t’.

Knowing when to comply with the ‘Should Haves’ can mean the difference between a large, costly, tedious quality program that hinders your ability to manufacture and sell product, and a streamlined program that serves the purpose of providing safe to consume products to your customers while not being a costly or burdensome program to run.

Kurt Schneider, CFS has many years of experience developing these programs for small businesses, and can help you determine which ‘Should Haves’ you need to follow, and which ones can become ‘Nice to Haves.’

When considering regulatory compliance programs, it’s important to remember both federal and state requirements. Kurt C Schneider is a food and nutraceutical compliance expert who is well-equipped to help you navigate these (often overwhelming) waters.

Remember; even if it is the contract manufacturer who produced, stored and shipped your product, in the eyes of the Federal Government, you as the Brand Owner are 100% responsible for any issues your product causes in the marketplace. That means you need to be aware of anything and everything your contract manufacturer is doing while manufacturing and holding your product. Kurt Schneider, CFS works with the contract manufacturer to ensure all activities are transparent to the Brand Owner, and records are provided for every batch made.

It is fast becoming a ‘must have’ for new products to be certified Natural, Organic, Gluten-Free, Non-GMO, Dairy Free and the like. Most of these certifications are based on either written Federal regulations or state requirements. In some cases, such and labeling your product as ‘Natural’, there has been no standard developed by the FDA to date. While that makes it a simple process to label a product ‘Natural’, there are numerous interpretations of what ‘Natural’ means. To determine if your product can be labeled ‘Natural’ requires knowledge of all the interpretations and choosing the correct one. Kurt Schneider, CFS has helped many of his clients make this determination, as well as helping them navigate the government requirements for all the other types of labels you might want to add to your product.