NutraStar Secures Valuable Food Defense Certification and Engages Workforce with NJMEP’s Help

Background

NutraStar is a local manufacturer that specializes in producing custom formulated tablets, capsules, and powders for nutraceutical brands. Located in Farmingdale, NJ, NutraStar has a staff over 250 employees on-site and they manufacture 10 million capsules, 100,000 bottles, and 10,000 kg of custom formulated powder per day, all out of their 60,000 square foot production facility. They are one of the top contract manufacturers for leading supplement brands. NutraStar manufactures their custom formulations using the highestquality raw materials.

Their products, especially capsules, provide quick and efficient dosesfor supplement consumers. They have some of the most technologically sophisticated encapsulation machinery available on the market and deliver their products within industry-leading turnaround times.

Challenge

The FDA requires food manufacturers to comply with the latest food defense requirements. NutraStar needed to ensure its workforce was trained on the proper food defense strategies before the FDA’s next visit. In addition, NutraStar understood they needed to take this training seriously and maintain their food defense practices after its FDA audit to remain in good standing with the global safety science organization, UL Solutions. The UL helps companies to demonstrate safety, enhance sustainability, strengthen security, deliver quality, manage risk, and achieve regulatory compliance. The audit encompasses all GMP regulations.

NutraStar was looking for a partner that can help them remain compliant with both the UL and FDA. The FDA recently started requiring food manufacturers to follow the food defense regulations to be considered compliant and receive their GMP certification. Without the GMP certification, it would be difficult for them to continue operating. Customers have requested that NutraStar have the certification before continuing business with them. Customers will check for the certification on a third-party database.

“We knew that if we weren’t compliant and we did not follow through with the full process, there’s no way we would get that certificate and we wouldn’t be able to show it to our customers,” explained NutraStar Director of Quality, Sam Brownstein. “They have a way of looking us up in a database. They know that even if we say we’re working on it, and we’ve gotten an extension, but if that deadline had come and we didn’t have an audit, we would not be in the third party’s database. That would be a major loss of customers. We needed to comply, and we needed to have training, and we needed our staff to have an understanding of what the requirements are.”

Solution

NutraStar explored options to upskill their staff and become certified by the FDA’s upcoming deadline, and discovered NJMEP has the expertise that would address all their needs. They reached out to NJMEP for help and explained their challenge to the NJMEP account manager.

Their account manager is familiar with the regulations, the timeframe needed for preparation, and its importance. The account manager knew they didn’t have much time to prepare so he worked with NutraStar’s team to quickly develop a plan. A plan was created immediately after the account manager surveyed their facility and staff and saw how much time they would need for food defense training and certification.

“Within a couple of weeks, the trainer was here. It was a very good experience. The trainer was very hands-on and got everybody involved. Everybody was really able to walk away after that and write their own program for this food defense, which was quite unique,” Brownstein said. “The trainees, and everybody on the team that was trained, came back and told me it was interactive, it was fun, and it was something that they would do again with this trainer. That was like a game changer to me.”

The key topics that were discussed:

• Understanding the importance of a food defense and training
• Explaining actionable process steps (APS), mitigation strategies
• Describe ways to protect food from intentional adulteration
• Understanding how to recognize and report suspicious activity
• Review FDA Employee FIRST Learning Objectives
• Review employees, role in preventing intentional adulteration

Training took a total of 12 hours to complete, including the eight hours of on-site training and four hours of training customization. The training’s focus was on the physical structure for food defense elements to help better explain 21 CFR 121 regulations. Working with a knowledgeable consultant to come up with a quick plan allowed NutraStar to have food defense certification before the deadline, become GMP certified, and ultimately continue their business with customers.

Results

NutraStar’s staff received their certification after completing the food defense training, and they completed all the requirements in time for their next audits with the FDA and UL. They also received a perfect audit score of 100 as a result of the training provided by NJMEP’s team. This in turn drew more interest from customers who specifically look at audit scores before continuing business.

The results below reflect the impact NutraStar experienced while engaging with NJMEP:

• Retained Sales: $10,000,000
• New Sales: $2,000,000
• Retained Jobs: 2
• New Jobs: 2
• Cost Savings: $20,000