I had the privilege of working a decade for Jarrow Formulas. During my tenure at Jarrow, I had the opportunity to witness the opening of Jarrow Formulas’ sister company, Jarrow Industries, now a 135,000 square-foot Pharmaceutical Grade, cGMP-certified contact manufacturing facility located in Santa Fe Springs, CA. If you’ve ever had the chance to tour these cool facilities, I encourage you to do so. They are unbelievable.
Unless you’ve been living in a cave over the past several months, the natural products industry has seen a significant increase in regulations by the FDA. For years, the dietary supplement industry has been scrutinized by the media for deceptive marketing. And rightfully so. Many of the health claims that have been featured on product labels border on obscene. I’m not saying this was widespread and that many companies were doing this. I am saying that the actions of a few had a profound impact on our industry. Under-regulation by the FDA led to legitimate concerns that these products were getting a pass on playing fair. Until now.
New FDA regulations for the dietary supplement industry look to eradicate consumer concern and the potential health risks associated with these products. Dietary supplement contract manufacturers are now required to adhere to GMPs. The FDA 21 Code of Federal Regulations (CFR) Part 111 was established to insure the identity, purity, quality, strength, and composition of dietary supplements and applies to those involved in the manufacture, packaging, labeling or holding of a dietary supplement, with the exception of retail establishments selling directly to consumers.
These new regulations not only mandate that contract manufacturers adhere to cGMPs, but has also ratcheted up competition in an industry that is seeing robust growth. In fact, according to a new Packaged Facts report featured on the nutraingredients-usa.com entitled Nutritional Supplements in the US, domestic dietary supplement sales grew 7% in 2012 despite the awful economy. The report says sales were $11.5 billion in 2012 and forecasts that sales will reach $15.5 billion in 2017. We are truly in a growth industry!
Interestingly, contract manufacturers have had to make every effort to separate themselves in a very competitive landscape. I have personally been in dozens of facilities that have a wide range of compelling capabilities. That said, I reached out to a gentleman I genuinely respect, Eugene Ung, CEO of Best Formulations, based in City of Industry, CA about this topic. I found his feedback to be particularly right on point. He believes a first-rate contract manufacturer should bring the following to the table.
And I’ll get to those qualities in my next post.