The natural products manufacturer said that it was first alerted to the issue on Jan. 5 by a ConsumerLabs.com report and immediately launched an investigation that confirmed that some of the items in four lots indeed fell short of specification.
“While there is no health risk in this situation, we take regulatory compliance and meeting label claims seriously, and giving consumers what they pay for even more seriously,” said Dan Richard, NOW Health Group VP of global sales and marketing. “We are issuing a voluntary recall and being transparent with the industry as a first step, to be followed by adding additional safeguards to our quality assurance protocols, especially for products we don’t make ourselves.”
The recall covers lots #3316650 and #3309243 of NOW Phosphatidyl Serine Extra Strength 300 mg Softgels (50 count) and lots #3309194 and #3316624 of the Protocol for Life Balance practitioner brand, marketed to support cognitive health. NOW confirmed fewer than 10,000 units of the NOW brand and less than 3,000 units of the Protocol brand have been sold.
A blending issue
The investigation traced the inconsistencies to a contract manufacturer and attributed the source of the problem to “difficulty blending lecithin and achieving uniformity”.
“Various product testing confirmed 30 mg and 55 mg per soft gel for some units and over 300 mg for others from the same lot,” Joshlyn Atoyebi, senior compliance manager at NOW, told NutraIngredients-USA. “[T]his is how we can tell that the problem is a blending issue with the contract manufacturer rather than a problem with the phosphatidylserine itself.”
NOW manufactures close to 80% of its dietary supplements at its in-house facilities across the U.S. and Canada and relies on 25 different contract manufacturers to supplement its internal capacities. It highlights its commitment to rigorous quality protocols, which include over 19,000 quality tests a month throughout the manufacturing process in its ISO-accredited labs.
In the case of the phosphatidylserine lots, NOW said that products are formulated with a standard 324 mg, representing an 8% overage, and that pre-shipment samples tested in its third-party ISO-accredited analytical and microbiological lab passed at over 300 mg/softgels.
“Obviously, in light of this situation, we will adjust our testing procedures and protocols with our contract manufacturers to ensure that this never happens again,” Atoyebi said. “NOW continues to focus on comprehensive testing and will only continue to get better.”
Focus on quality assurance
This comprehensive testing extends to surveillance of other supplements on the market through a product policing program NOW launched in 2017 to check whether unfamiliar brands sold on Amazon meet label claims.
The 17 testing rounds to date have uncovered “subpar” to “baffling” to “abysmal” results tied to potency, labeling, contamination, adulteration and heavy metal level issues across over 150 tested products, including “serious failings” in the phosphatidylserine category.
NOW said that it is working with the U.S. Food and Drug Administration to execute its recall, which includes contacting all customers who ordered the affected products with detailed instructions on next steps.
