LAS VEGAS—The SupplySide West education sessions, sponsored by BASF, continued on Wednesday, with attendees taking timeout to get updates on key regulatory issues and learn about market trends that could yield new product opportunities.

The issue of endorsements and testimonials has taken on new complexity with the emergence of social media in the business world. Attorney Justin Prochnow, Greenberg & Traurig LLP, said FDA and FTC are looking at social media sites to determine if a company shows intent to sell products for diseases. Also, anything said by an endorser is considered a statement by the sponsoring company, and endorsers talking about products on social media sites like Twitter need to disclose material connections to advertisers by including appropriate hashtags, such as #endorser or #paid. “The No. 1 source of agency action is disclosure,” he said.

In Europe, the big issue and major concern for industry is the present EFSA (European Food Safety Authority) opinion on claims, which threatens to become law as-is, which would severely and negatively impact dietary supplements and foods in the European Union (EU), according to Martin Last, Health Food Manufacturers Association (HFMA) and MPL Marketing Services. As it stands, the EU is appears to be applying a drug assessment model to food/supplements, resulting in a 97-percent failure rate for generic claims (similar to U.S. structure-function claims) submissions. Last said HFMA and other industry associations across Europe have joined forces with other stakeholders and even academics and the scientific community to fight the pending legislation.

Back in the United States, GMPs are still a big issue, even if NDIs are currently taking up most of the industry stage. Joy Joseph, Joys Quality Systems, told a packed audience of manufacturers, “You need to worry about GMPs, because you are failing.” The former Pharmavite quality-control expert also advised companies, “Get it in your head that if you aren’t in compliance with GMPs, your products are adulterated.”

She reminded all companies were required to be in compliance a year ago, even if they haven’t yet faced inspection. Among her detailed advice on how to comply were suggestions for how to write specs for procedures, processing, vendor qualification, laboratory operations and testing. In fact, she noted the No. 1 issues with GMPs has been failure to test and raw material and/or qualify the supplier and certificate of analysis (CoA). One tip she offered was to consider FDA’s allowance for subset testing utilizing a statistical sampling program. Above all, she urged companies to learn all about the reg, train all employees on GMPs, write procedures and document/retain everything. As all this can be overwhelming for companies large and small, she recommended companies get help on any of the GMP requirements from the plethora of resources available.

Sharrann Simmons, Silliker, also took on an aspect of regulatory oversight, helping audience members understand the top-line impact of the Food Safety Modernization Act (FSMA) on dietary supplement manufacturers. As she noted, because supplements are regulated as a subset of foods, producers must comply with almost all aspects of FSMA, with the notable exception of mandatory compliance with supplement GMPs. Simmons ran through not only the philosophy behind FSMA—hazard analysis plus preventive controls—but how the implementation is proceeding. She called out three parts of FDA's strategic plan for 2012 to 2016 as particularly of interest to supplement companies. Specifically, the agency noted it will aim to develop and implement compliance and regulatory strategies to address dietary supplement safety issues; advance post-market surveillance in dietary supplement regulations; and advance pre-market oversight of dietary supplements via the NDI guidance.

Switching gears, two nutrition presentations on Wednesday addressed market trends and business strategies. Greg Stephens, Windrose Partners, talked about key success factors and the critical aspects that companies should look at when making a decision about commercial product development. Such aspects include whether there is an unmet consumer need; an available market opportunity; the lifestyle fit for consumers; and product safety and efficacy. In addition, one aspect of increasing importance is sensory and organoleptics, as mass market consumers have higher standards for taste, and how preventive products meant to be consumed over time must meet taste and sensory requirements.

The final presentation on Wednesday featured Datamonitor's Tom Vierhile on the topic of personalized nutrition and the future of functional foods. He set the stage by noting the majority of global consumers attach high importance to individuality and self-expression. Manufacturers are already delivering products for more targeted markets—think gluten-free or other allergen-free items. Nutrigenomic products, Vierhile argued, could be seen as the next step in the continuum of functional foods; three items driving the interest in this area and in personalized nutrition are the distinctiveness of genetic profiles, a growing focus on prevention, and the potential cost savings to society.