As we reported yesterday , Oregon’s top law officer Ellen Rosenblum filed a petition against 5-Hour on December 23 to compel it to comply with a Civil Investigative Demand (CID) she issued last January.
This seeks information to advance a multi-state investigation (with Oregon one of five lead states) into the safety and advertising of the energy shot; however, 5-Hour hotly contests the petition, and claims it has already complied with the CID.
Elaine Lutz, spokesperson, told this website last night that 5-Hour's parents, Innovation Ventures and Living Essentials, “have cooperated and worked collaboratively with officials taking part in the inquiry of 5-Hour Energy advertising, including producing all of the necessary information for in-depth scientific review 5-Hour Energy products.
“In fact, the ownership of 5-Hour Energy’s formulations provided all the ingredients – only redacting specific amounts, which it considers highly confidential, and proprietary trade secrets,” she said.
Brand fears loss of key competitive advantages
Lutz said that 5-Hour’s owners are contesting the release of specific formulations, since competitors had actively sought the information.
“The business is not confident that its proprietary formulas can be properly safeguarded as a ‘trade secret’ if turned over to government officials,” she added.
Describing Rosenblum’s request for the formula (to properly investigate 5-Hours’s ‘no crash’ claim) as “overreach”, Lutz said: “Our business will lose key competitive advantages if it is compelled to disclose its highly confidential formula information that makes 5-Hour Energy shots the leading products in its category.”
“Such disclosure would destroy the economic value of our innovative efforts, potentially arm our competitors and deprive our business of the benefits of our innovation.”
Trade secrets threatened by ‘electronic age’
5-Hour had worked for a decade and spent significant sums to protect its proprietary formula, Lutz said.
This comprises Citicoline, Tyrosine, Phenylalanine, Taurine, Malic Acid, Glucuronolactone, Caffeine (200mg) and Vitamins 3, B6, B9, B12, while the four-calorie, 2oz shot that uses sucralose.
“In this electronic age, one person can irrevocably destroy the privacy of information by posting content to the internet, whether acting innocently, negligently, or intentionally,” Lutz said.
These arguments don't wash with Oregon assistant attorney in charge of the Health Fraud Unit of the Financial Fraud and Consumer Protection Section of the state's Department of Justice (DOJ), David Hart, who on December 24 made a declaration supporting Rosenblum's petition for full disclosure of ingredient levels.
"Unredacted versions of documents at issue are necessary for DOJ to make an informed Unlawful Trade Practices Act (UTPA) enforcement decision," Hart, who is leading Oregon's investigation, wrote.
"This is especially true at this early investigative stage, in which DOJ is attempting to gather evidence to determine whether probable cause exists to bring suit for a UTPA violation," he added.
Oregon is investigating 5-Hour for 'misleading statements' under three heads: the 'no crash' claim, the product's suitability for children and a 'Doctor's Recommend' advertising campaign.
Oregon state attorney questions 5-Hour's safety
Hart notes that 5-Hour has been subject to 92 adverse incident reports from the Center for Food Safety Adverse Event Reporting System (CAERS), a US Food and Drug Administration (FDA) database related to specific products.
"Eleven of the adverse events reported for 5-Hour Energy involved fatalities. Others involved heart attacks, chest pains, increased heart rate, heart arrhythmia and spontaneous abortion," he wrote.
Earlier in the document, Hart warns that the health effects of 5-Hour's ingredients - including tyrosine and phenylalanine in tandem with caffeine - are not known.
Addressing the Oregon assistant AG’s concerns over the safety of 5-Hour Energy, Lutz said the brand was introduced in 2004 and now sold nine million bottles a week.
Marketed as a dietary supplement rather than beverage, 5-Hour Energy is designed for adults not children, she added, and is safe when consumed according to recommended use guidelines.
As a dietary supplement, the shot complies with the Dietary Supplement Health and Education Act (DSHEA) regulations for labeling, manufacturing practices, Lutz said, and its ingredients are Generally Recognized as Safe (GRAS) by the US FDA.
*Article amended 8/1/14: 5-Hour Energy contains sucralose, but not Tate & Lyle's Splenda sucralose, as previously mentioned.