Introduced yesterday, the thin strips adhere to the tongue, where they dissolve to release probiotics into the mouth.
According to Ganeden, they provide “an alternative for individuals who are unable or prefer not to take supplements in pill or liquid form.” The strips are particularly suited to children or the elderly, said the firm.
The product, which Ganeden intends to license to manufactures for private label use, is said to deliver up to 1.5bn CFU (colony forming units) per strip.
Regulation: Supplements or not?
The regulation of strips such as these can be two-fold: Some products can be classified as supplements, whereas others cannot.
In an e-mail to NutraIngredients-USA.com, FDA clarified its position:
“As long as the product is intended to be swallowed, its physical form of delivery does not matter. Thus, dissolvable strips, lozenges, etc. can all be dietary supplements. The key aspect is that they are intended to be swallowed - that is what will satisfy the ‘intended for ingestion’ element of the statutory definition,” wrote an agency spokesperson in an e-mail.
“If, however, they were intended to be dissolved in the mouth and absorbed prior to swallowing, they would not be dietary supplements.”
In terms of what category the latter type of product would fall under, FDA said it would have to review its packaging in its entirety to make a determination about the appropriateness of its labeling.
Ganeden told NutraIngredients-USA.com that it will be marketing its product as a supplement. “Our directions will say ‘dissolve on tongue and swallow’ – so this will create a liquid mixed with saliva that will be injested.”
In a press release announcing the launch of the strips, Ganeden’s CEO Andrew Lefkowitz said the “innovative application is another step forward in expanding the breadth of convenient products available to consumers”.
Ganeden said it was able to overcome the challenges of formulating a probiotic strip that delivers an effective probiotic dose.
Previously, said the firm, “probiotic thin strip applications were limited as the harsh manufacturing conditions required to develop the strips would render most probiotic strains ineffective”. The company’s branded GanedenBC30 – a spore forming bacterium – survives the process due to its protective hardened shell.
The director general of the International Probiotics Association (IPA), a trade group, agreed that other companies have attempted to develop probiotic strips but were unsuccessful due to the inability of the strain to survive.
Ganeden had said it did intend to market the product under its own consumer brands, but to provide it to manufacturers for their own branding.
The strips are available in 10 and 30 pack boxes of individually foil-packed strips.
Other supplement delivery systems developed by Ganeden include tablets, chews, drink mixes, effervescent tablets and liquid suspension. In addition, it recently introduced a system allowing probiotics to be stored in a bottle cap and dispensed into the drink at the point of consumption.