Why GMP Certification Matters When Selecting a Gummy Manufacturer in the USA

The gummy supplement industry is booming right now, and as per some forecasters, it’s expected to cross $27 billion by 2034. A significant portion of this massive pie is expected to come from the USA, which, as of now, is the largest supplement consumption market in the world. 

Most people are now opting for gummies for their vitamin and mineral needs instead of plain old capsules and softgels. So, for businesses that want to capture this huge demand, signing up with a GMP-certified gummy manufacturer in the USA is very important. 

Especially if the plant is to go with a nationwide launch, which requires quick, reliable, and scalable manufacturing partners like TrustWorks, GMP certification is what separates safe and reliable products from potential disaster launches. This article will explain what exactly GMP certification entails and why it’s a non-negotiable thing when signing up with a gummy contract manufacturer. 

What is GMP Certification in the Gummy Industry? 

GMP stands for Good Manufacturing Practices. In some places, it’s written as “cGMP,” where “c” stands for “current” and means that the firm regularly updates with the latest science and technology standards in the industry. 

The FDA (Food and Drug Administration) sets these standards for dietary supplements, including gummies, capsules, softgels, tinctures, and more. These standards include everything from how facilities shall be designed to testing and storage protocols. 

Other than the FDA, third-party organizations like NSF and USP also indulge in a facility certification program, which then adds a further layer of verification and scrutiny beyond basic FDA compliance. The in-depth regulation details can be found in the FDA’s 21 CFR Part 111. 

Specific GMP requirements for gummy manufacturing 

• Water activity must stay between 0.55 and 0.70 to avoid microbial growth.
• Every batch should be weighed to ensure the right dosing per serving.
• Proper testing protocols to be adopted by the manufacturer to match label claims and values
• Raw material must be vetted before admission to the facility and should come from a verified supplier.
• The procedure environment must be sterile with the right temperature, humidity, and hygiene values to prevent the risk of contamination.

Why GMP Certification Matters When Selecting a Gummy Manufacturer

Let’s take a look at the top 3 reasons that sum up the importance of GMP certification: 

1) Consumer Protection + Product Safety 

GMP certification is a seal of assurance for both product and consumer safety. GMP-certified manufacturers have systems in place to prevent microbial (mold, bacteria), chemical (pesticides, heavy metals), and physical contaminations (glass shards, metal fragments). 

The certification forces the manufacturer to match the label claims with actual product concentrations, which is quite important in the supplement industry. If a consumer is taking a 500 IU vitamin D gummy, they should get the same amount in every serving of the bottle. 

Without GMP standards, there’s a huge risk of cross-contamination in facilities where multiple products are manufactured in the same place. For example, someone who has a nut allergy can fall seriously ill if the facility makes both nuts and gummies, and proper cleaning and separation of equipment don’t happen. 

2) Legal Protection and Regulatory Compliance 

Under the Dietary Supplement Health and Education Act, the FDA requires every supplement manufacturer to follow GMP standards. Those who don’t adhere to these guidelines are in clear violation, and signing up with them can lead to raids and seizure of your products by enforcement agencies. 

In simple words, if you are working with a non-certified gummy manufacturer, you are breaking the federal law. Product recalls, raids, warning letters, facility shutdowns, and expensive legal battles are something that any budding or established brand would like to avoid. 

Building back from such blowback is almost an impossible task, as it tarnishes the brand image for good. Plus, having GMP certifications also opens up access to international markets. Most countries won’t import your products if they are not GMP certified. 

3) Risk Mitigation and Supply Chain Integrity 

GMP certification cushions you from supply chain problems. Certified manufacturers keep proper records of what ingredients are being used, what their quality is, and whether the supplier is vetted or not. 

They ask for quality certification for every raw material batch shipped to the facility so that it meets the specifications of the client. This brings down the risk of fraud, especially when cheap knockoffs flood the market or large-scale in-ground dumping from foreign players happens on a large scale. 

If any problem happens in a batch and it fails the quality testing, it can be easily recalled to check which ingredient causes the issue. Also, insurance companies appreciate the established protocols and offer better rates and protection guidelines to brands working with GMP-certified manufacturers like TrustWorks. Hence, from a liability point of view, you are much better protected. 

Why Return on Investment Is Better when Opting for a GMP-certified Manufacturer

It’s a known fact that a GMP-certified manufacturer will charge a slight premium as compared to a non-certified one. However, for this little cost, you get many advantages and save money in the long term. Here are some major benefits: 

• Faster market reach without regulatory delays
• Access to premium retail chains and online stores
• Better consumer trust and chances of repeat orders
• International expansion is easy, with entry into new markets.
• Better risk management, low insurance premiums
• Reduced the risk of batch recall due to poor ingredient quality
• Faster scalability during high-demand seasons

The End Note

If you are reading this, you are now well-equipped to understand the importance of GMP certification in a supplement manufacturer. This certification is a stamp of approval for quality and consistency and can play a pivotal role in your gummy brand’s success. 

The moment people see GMP certification, their trust in your brand gets better, plus your products don’t get seized during FDA raids, and you get better access to international markets. 

So if you are planning to launch some exotic gummies soon, please tie up with GMP-certified manufacturers like TrustWorks for the best results. Not only will it save you money in the long run, but it will also help in establishing a solid brand image. It’s like a reinvestment in your brand’s future.