Herbalife, the biggest company in the dietary supplement industry by yearly sales, is strongly behind the new database which went live in late April. The database is a cooperative effort among trade organizations and other industry stakeholders. Vasilos (Bill) Frankos PhD, Herbalife’s senior vice president for global product science, safety and compliance, said he believes it will grow to be the kind of resource he wished he had during his time at the Food and Drug Administration, where he was the director of what was then the Division (now Office) of Dietary Supplement Programs.
Helping FDA understand marketplace
“I do think it will be a major initiative that will improve transparency and will assist FDA in understanding the marketplace in totality,” Frankos told NutraIngredients-USA.“It will provide them with a lot of data that they didn’t have before.”
The Supplement OWL allows users to access the registry through the internet and to search product entries by brand name, ingredient, health category and a host of other options. The registry provides ingredient listings, serving sizes, a copy of the Supplement Facts box, and other information about the supplements.
A second tier includes additional information that may be voluntarily submitted by each dietary supplement manufacturer. For example, manufacturers may choose to include information such as third-party cGMP certifications, product specifications, documentation of supply-chain and/or production sustainability programs, or other product credentials. Manufacturers have the option to determine who will have access permission to view the information submitted in Tier 2. This section will include a nominal charge.
Getting started with uploading labels involves a three-step process, beginning with outreach to UL, the global independent safety science company who is developing and administering the technology that drives the Supplement OWL, to learn what product and label information will need to be submitted. Then, companies can choose from four options to determine the best method to submit their labels: 1) electronic transfer from an existing IT system; 2) conversion from the ODS label database; 3) manual data entry; or 4) a third-party upload service.
Filling in the manufacturing gap
Frankos said one of the key parts of the database will be a confidential panel which only individual companies and FDA can see. This will allow companies input information that they would otherwise deem proprietary. This could be especially helpful in this day and age when so many products are made by contract manufacturers, he said.
“It will include information about where the product is manufactured and who is the immediate contact,” Frankos said. “FDA does not have much manufacturing data, and that is a weakness as far as FDA is concerned. If the agency knows where a product is being manufactured, they can stage a confidential inspection. If they have to ask first where products are made, people get on the phone and the contract manufacturer knows you’re coming before you get there.”
Frankos said the Supplement OWL could also help companies interact better with their retail partners. As the demands for transparency increase, retailers are starting to ask more and more questions, causing suppliers and brand holders to have to generate reams of paper for each new client. Much that information can now reside in teh database, Frankos said.
“Retailers are going to start asking what kind of information is available to them. Companies won’t have to generate new letters basically regurgitating all this stuff ever time they want to sell products to a new retail partner,”he said.
A better industry
The hope is that the Supplement OWL will help weed out bad actors in the industry. The rejoinder could be that the bad actors have always flown under the radar and would likely be happy to continue to do so. While participation in the database is voluntary, as it gains traction, having your product listed there could become something of a precondition for market entry, Frankos said.
“Over time there will be continuing pressure on the industry to be transparent and the OWL is where you will put this information. If major retailers start to only accept products that are in the Supplement OWL database, that limits where you can sell your products if you chose not to participate,” he said.