FDA’s Fabricant Gives Address at SupplySide West

SupplySide West drew 12,000 industry members November 12–16 in Las Vegas, NV. According to show organizers, this marks a 11% increase in attendance. A main attraction of the event was featured speaker Daniel Fabricant, Ph.D., director of the Division of Dietary Supplement Programs at the U.S. Food and Drug Administration (FDA). Fabricant spoke about several regulatory issues like good manufacturing practices (GMPs) and warning letters.

On that front, companies may not realize they are breaking rules when they tout a good FDA inspection in press materials. “There are no gold stars for quality,” he said. “It’s what you are supposed to do.” Watch for more education sessions on GMPs from FDA, he predicted. He also touched on the redraft of the new dietary supplement ingredients guidance, noting that it has been delayed.

Potential targets for future FDA activity could be caffeinated products, as the agency is concerned with how much caffeine children and pregnant women may be consuming without their full understanding. In addition, he believes that kratom leaf has no place in legitimate dietary supplements because large doses can be dangerous. They have been implicated in several emergency room visits among individuals wishing to achieve an opiate-like effect.

Henri Harland, president and chief executive officer, Neptune Technologies & Bioressources; John Elway, Neptune ambassador; and Howard Schiffer, founder and president of Vitamin Angels.

Fabricant also believes there is a lot of adulterated glucosamine on the market, and that dietary supplements intended for “inflammation support” may be problematic because it is a disease state, in his view. He added that “inflammation” claims must be properly qualified, and that is not easy to do.

The FDA official also spoke about possible recalls of natural supplements that may pose a health threat due to contamination with an antibiotic called chloramphenicol. Raw materials supplied by an industry company (Specialty Enzymes) may contain trace amounts of the natural antibiotic, and have been voluntarily recalled even though the risk of a serious adverse health consequence is remote, says the firm. Chloramphenicol isn't used in the manufacture of the enzyme, but "the issue is believed to originate with agricultural raw materials supplied to an international enzyme manufacturer, from which Specialty Enzymes sources some materials," says the company.

The end result, said Fabricant, is that we may see some finished products made with the affected lots recalled. On November 8, for instance, Sequel Naturals voluntarily recalled Vega One Nutritional Shakes and Sports Performance Protein as a precautionary measure.

Another big event during SupplySide was the second annual charity poker game to benefit Vitamin Angels, sponsored by Neptune Technologies & Bioressources Inc. Attendees had the chance to meet John Elway, ambassador of Neptune’s NKO krill oil and former Denver Broncos quarterback and Hall of Famer. In total, Neptune gave Vitamin Angels $78,500. In addition, Neptune’s Xavier Harland won first place at the tournament, with second place going to Elway. Both men gave their winnings to Vitamin Angels.

WholeFoods Publisher Heather Wainer (right) meets two-time Olympic Gold medalist in rowing Susan Francia at a Bioenergy event.

On the show floor, exhibitors offered much for attendees to see and do. Biothera, based in Eagan, MN, sampled new applications of its Wellmune ingredient, including beverages, children’s gummy supplements and CocoWell truffles. Bioenergy Life Science of Minneapolis, MN, had two Olympians at its booth: two-time Olympic Gold medalist in rowing Susan Francia, and Nordic combined skier Billy Demong, Olympic gold and silver medalist. Both spoke with attendees about how Bioenergy Ribose benefitted their performances.

Sabinsa Corp. of East Windsor, NJ, gave out ProbiOatie Cookies made with LactoSpore. Bridget Reilly, owner of The Bite Market specialty grocer in Orange, CA, makes the gluten-free cookies and sells them from her store. Embria Health Sciences offered the chance to meet Olympian and soccer star Christie Rampone, who told attendees why she is a true believer in EpiCor.

In addition, SupplySide Editor’s Choice Awards Winners were honored in Vegas. The winners were:

Animal Nutrition: Timberline Live Pet Foods for Vita-Bugs

Antioxidant Supplements: Insightful Solutions LLC for OJO Nectar

Beverages: Reed’s Inc. for Culture Club Kombucha

Digestive Health: Patient One MediNutritionals Research LLC for GI One

Functional Food: Ruby’s Naturals LLC for Ruby’s Rockets

Hair Care: Eufora International for Eufora Thickening Collection

Multivitamin: Rainbow Light Nutritional Systems for Embrace Prenatal 35+ Multivitamin

Nutricosmetics: NeoCell for Beauty Bursts

Omega-3: Omega-3 Innovations for Omega Heaven™

Organic: Numi Organic Tea for Savory Tea

Packaging Design: Stack Wine for Stackers