The FDA regulates nutraceutals as dietary supplements. You are right in that they cant claim health benefits that don't exist or aren't proven, but I don't see that being too difficult. They dont need to make such claims as the actual market for the product has created that narrative for themselves. The regulation is far more lenient from the FDA when compared to pharmaceuticals. If Herbalife, with some of the stunts they have pulled over the years, have managed to operate in the US like they have (weight loss claims, a product associated with liver failure, using the FDA as marketing) I don't see any issue for NZS.
Extract from the FDA website regarding the administration of the Dietary Supplement Health and Information Act:
"Manufacturers and distributors of dietary supplements and dietary ingredients are prohibited from marketing products that are adulterated or misbranded. That means that these firms are responsible for evaluating the safety and labeling of their products before marketing to ensure that they meet all the requirements of DSHEA and FDA regulations.
FDA is responsible for taking action against any adulterated or misbranded dietary supplement product after it reaches the market."
Also, NZS already has listing approval from the FDA and European Union to export to the United States and Europe respectively. They shipped Mussel Powder to the EU last quarter. The "doors" to these economies are already opened.
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