Relaxation drink fails to go down well with the FDA


Makers of Drank defend safety, benefits of beverage

By Ashley Luthern

aluthern@vindy.com

YOUNGSTOWN

A new drink available in Ohio invites users to “slow your roll” and relax — but some critics say it mirrors an illegal drug in appearance and effect.

Drank was the first, and now the most popular, of the relaxation beverages. It contains valerian root, rose hips and melatonin — a legal over-the-counter sleep aid.

The concept of Drank came to Peter Bianchi, chief executive of Innovative Beverage Group, which distributes the grape-flavored beverage, when he was a drummer in a touring band.

“You can’t go on stage and miss your time or your beat,” Bianchi said. “... I don’t consume drugs or alcohol, and I had to perform in front of 20,000 people, so I had to be calm.”

This led to a three-year development stage, when Bianchi went to health stores and researched natural sleep and anxiety aids. Melatonin was often recommended, so he said “it had to be in there.”

But because melatonin is not “generally regarded as safe” by the Food and Drug Administration, Drank had to be labeled a dietary supplement.

In a Jan. 13 warning letter to Innovative Beverage Group, the FDA cited studies of melatonin by the Natural Standard, a research collaboration that reviews data on alternative therapies. Although melatonin is usually safe at “recommended doses for short-term use only,” there are safety concerns, especially for children.

The letter stated that “there are limited studies regarding use of melatonin in children [younger than 18 years], and safety has not been established. ... Melatonin should not be used in children without consultation with a physician. ...Melatonin use should be avoided in women who are pregnant or attempting to become pregnant, based on possible hormonal effects ... and it may increase the risk of developmental disorders.”

The company has responded to the warning letter, but the case is still open, wrote Siobhan DeLancey of the FDA Office of Public Affairs in an e-mail.

Drank is distributed locally by Tri-County Wholesale Distributors Inc. of Youngstown, which is affiliated with R.L. Lipton Distributing Co. in Cleveland. R.L. Lipton inked a deal to carry Drank last month.

Bianchi said sales are up in Ohio because of use in the college-age or young-professional demographic.

“A lot of hipsters out there are drinking it because it’s in music videos, and lot of youth and a lot of people that play sports love drinking the product afterwards because it helps them unwind,” Bianchi said. He added that many college students drink it after pulling all-night study sessions.

A vocal opponent of Drank is Dr. Ronald J. Peters Jr. of the University of Texas Health Science Center, who says the company is relating the product to “purple drank” or “sizzurp” — cough syrup mixed with a clear soda.

“The can says Drank, and that is a term for codeine and promethazine that has been prostituted by this company,” Peters said. “It’s taken from the streets to have the social appeal for, in my opinion, a youth. It is purple stuff, which is another name for the codeine promethazine because it has a purple color.”

Bianchi disagreed with these claims.

“We did not come up with this product to emulate a narcotic,” he said. Instead, he said, the name was supposed to reference a hip vernacular that uses drank to mean “a cocktail that’s fun.”

“Purple drank” is popular in Southern states, and isn’t often seen in Ohio, said Lt. Robin Lees with the Youngstown Police Department and the Mahoning Valley Drug Task Force.

“Anything that can be abused, will be,” Lees said. “Any property in a chemical or vapor that causes any kind of altered state, people will pursue.”

Even though local police departments haven’t seen “purple drank,” it does not mean people are not aware of the term “drank,” Peters said.

“This has diffused throughout the nation now in different forms through the Internet, Facebook and as well as the hip-hop industry,” he said.

“...These things are not coincidental. Codeine promethazine gives people anti-energy, this is an anti-energy drink in a purple can named after the street name.”

Despite these allegations, the popularity of Drank continues to soar. It now is distributed in 38 states and expects to be nationwide in December.

The company has never received a complaint of health problems related to melatonin, and it does not condone drug use, said Eric Fischgrund, a senior account executive with Beckerman public relations that represents Innovative Beverage Group. Innovative is a Nevada-based corporation headquartered in Texas, where Bianchi is.

Bianchi himself said he will continue to focus on the beverage genre he created.

“I will not rest until I relax the world,” he said.