PLT Health Solutions, Inc. has published a new claims dossier for its Synapsa natural memory support ingredient. This dossier is a multidisciplinary, risk-informed approach to developing and using claims in the marketing of a natural ingredient. For the Synapsa claims dossier, PLT engaged the services of TAP-ROOT, a NJ-based company focused on claims substantiation and scientific communications, to provide an impartial review of the validity of the science supporting Synapsa claims. The publication includes a comprehensive list of suggested claims, a legal executive summary and in-depth reviews of the substantiation of claims. In the case of Synapsa, these include ‘chronic’ claims—that cover long-term use of the ingredient, ‘acute’ claims that are based around short-term, experiential use of the ingredient and general claims in the area of cognitive health. 
 
Synapsa Natural Memory Support is a patented, standardized form of Bacopa monnieri that has been the subject of more than 30 years of scientific study.  In six double-blind, placebo-controlled clinical studies, healthy adults using Synapsa showed significantly improved performance in areas such as visual processing, learning rate, working memory, information retention and mental performance in cognitively demanding environments versus a placebo regimen. The Comprehensive List of Claims in the new dossier includes in-depth reviews on supporting 19 different potential claims for consumer products that contain or feature Synapsa.
 
According to Dr. Barbara Davis, vice president of medical & scientific affairs for PLT Health Solutions, in an environment that focuses on proven efficacy and building trust at the consumer level, beyond addressing potential FDA-driven regulatory issues, a quality claims dossier can function as a company-wide lens to focus product development and launch efforts, and as a guide for research, marketing and quality management functions. “Claims reviews are increasingly becoming an integral part of managing the regulatory issues associated with efficacy claims for ingredients and formulated consumer products. But properly developed, the claims dossier has applicability beyond the regulatory function within a company— touching all phases of product development and commercialization and allowing smoother, more efficient and more powerful product launches,” she said. “An effective claims dossier can help consumer product development and marketing teams uncover new market opportunities and address these with confidence and integrity. What’s more, a dynamic dossier can identify gaps in the science surrounding an ingredient and suggest new end-points to improve the research supporting ingredients and formulated consumer products,” she added.
 
PLT360 – A Transparency & Trust Building Initiative
The new claims dossier approach that has been developed by PLT is an outgrowth of the company’s PLT360 initiative that considers Efficacy as an essential pillar for demonstrating quality and transparency for natural ingredients. The Efficacy pillar of PLT360 places an emphasis on delivering high levels of efficacy and the most positive consumer experience in each ingredient class the company offers. Premium ingredients offered for sale by PLT Health Solutions receive scientific evaluation to ensure that they offer best-in-class performance. For many ingredients, PLT conducts a multi-targeted, on-going program of scientific evaluation to support customer marketing activities and develop differentiation and intellectual property.
 
PLT frequently works with outside companies as part of a third party verification program of its scientific findings. For the Synapsa dossier, PLT selected Dr. Risa Schulman and her TAP-ROOT organization to provide guidance and analysis of the clinical trials that have been performed on Synapsa. “By combing the science both critically and with a focused eye towards appropriate regulatory use, the dossier presents a high quality, user-friendly assessment of the totality of the literature, providing a firmly informed basis to make claims use decisions with confidence,” said Dr. Schulman.
 
A Substantial Investment in Claims Support
The Synapsa Claims Dossier is available to customers of PLT who are actively developing or marketing consumer products that include the ingredient—and not to the general public. The PLT Medical & Scientific Affairs team plans to work closely with customer scientific and marketing teams to communicate the depth and potential power of the dossier for their product development efforts. “This next-generation claims dossier is a new way of thinking and communicating about claims that takes into account PLT experience in academia, in consumer product development and in decades of supplying science-supported branded ingredients. We’ve had customers tell us that we can save them 6 months of product development time with this type of documentation,” said Dr. Davis. “It also represents a commitment to transparency by PLT. Our work with Risa Schulman and TAP-ROOT was essential in developing the Synapsa claims dossier. Her familiarity with the current regulatory environment and the needs of consumer products companies informed her insights and the rigor with which she reviewed our science. We’re excited about the ability of this approach to add real value to our relationships with our customers,” she added.
 
For more information: www.PLTHealth.com