FDA Warns NYSW On Manufacturing, Marketing of VBlast

vblast_acaiThe U.S. Food and Drug Administration (FDA) has sent a warning letter to NYSW Beverage Brands, claiming the company failed to comply with manufacturing requirements for its VBlast line of cap-activated drinks.

In a complaint dated Jan. 7, 2015,  the FDA also indicated that NYSW’s labeling of VBlast products as liquid dietary supplements is contentious because the company represents them as beverages, both by using the words “water” and “punch” in product descriptions, and by packaging them “in a similar manner to other beverage products, such as vitamin waters.”

The action is reminiscent of similar warnings taken against Rockstar Energy, Revolt Distribution and Lithia Mineral Water in 2012. In Rockstar’s case, the FDA warned the company over its Rockstar Roasted energy products, which, despite being labeled as supplements, were represented, advertised, and sold as beverages. Moreover, the agency viewed the line as “adulterated” because it included Ginkgo, which the FDA lists as an unapproved ingredient for use in food and beverage products. Along the same lines, the agency rapped Revolt Distribution for labeling its Slowtivate relaxation drink as a dietary supplement while marketing it as a beverage. At the time, Slowtivate was formulated with the sleep-inducing hormone melatonin, which is also not approved for food usage.

The FDA’s letter to VBlast did not name a specific unapproved ingredient, instead citing a number of violations of the agency’s Current Good Manufacturing Practice regulations for Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements.

“These violations cause your dietary supplement products including, but not limited to, ‘VBlast Acai Berry,’ ‘VBlast Wildberry,’ and ‘VBlast Tropical Punch’ to be adulterated within the meaning of section 402(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 342(g)(1)] in that they have been prepared, packed, or held under conditions that do not meet CGMP requirements for dietary supplements,” the letter reads.

fda 150The agency noted that the “letter should not be interpreted to mean that FDA agrees with the characterization of your [VBlast products] as dietary supplements.”

“In fact, the labels for your “VBlast Acai Berry,” “VBlast Wildberry,” “VBlast Tropical Punch,” “VBlast Gator Pit Energy Formula,” and “VBlast Pomegranate + Cherry” products that we collected during our inspection revealed that these products are represented for use as conventional foods,” the FDA wrote.

Justin Prochnow, an attorney at Greenberg Traurig, LLP who handles civil litigation and regulatory filings for food and beverage companies, says that because there is a wider range of ingredients permissible in supplements as opposed to beverages, companies will often elect to sell their product as a supplement rather than a beverage.

“But if you’re going to sell your product as a supplement, then that’s what it is,” Prochnow told BevNET. “It’s not your energy drink. It’s not your energy water. It has to be your energy supplement.”

In January, 2014, the FDA issued a guidance for distinguishing liquid dietary supplements from beverages, which can be found here.

UPDATE: VBlast is now being sold and marketed as a beverage and not a dietary supplement. In a letter to the company dated June 5, 2015, the FDA largely approved of changes that NYSW Beverage Brands made to VBlast labels in response to the January warning letter.

“Our review of your response and revised labels has found that based on the changes made to your labels, your products listed below are now considered conventional foods. As such, these products are no longer subject to the Current Good Manufacturing Practice regulations for Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, found in Title 21 of the Code of Federal Regulations, Part 111 (21 CFR Part 111),” wrote FDA compliance officer Lillian C. Aveta.