DSHEA 2.0 Legislative Reforms Addressing Deficiencies in the Dietary Supplement Marketplace

DSHEA 2.0 Legislative Reforms Addressing Deficiencies in the Dietary Supplement Marketplace The Problem The Cause The Solution Undefined Marketplace Prevents FDA from Identifying & Adequately Assessing Products and Ingredients for Safety FDA does not know what products are • Supplements are often introduced and sold without FDA • Require that manufacturers list all products in a publicly accessibl. [...] Dangerous products can fall between • Supplements containing only non-dietary ingredients • Modify the definition of adulterated/misbranded supplements to the regulatory “cracks” (e.g., pure cannot be regulated as dietary supplements even if they include all products marketed as supplements or like supplements tianeptine or phenibut) are marketed as such that do not contain a dietary ingredient Su. [...] Code § 350b) ▪ [Alternatively] can no longer reasonably be certain of no harm (our recommended NDIN standard) Product dangers are underreported • Industry is currently obligated to only report serious • Require manufacturer reporting of all adverse events adverse events they receive from consumers to the FDA • Require supplement labels and online listings to include phone • Consumers lack adequate. [...] • Require companies to summarize data used to substantiate the claims Weak Enforcement FDA cannot keep up with marketplace • The former $4 billion industry comprised of about 4,000 • Provide Office of Dietary Supplement and Programs (ODSP) with growth, including increasing online unique products is now an industry worth more than $40 $10 million in additional funds to improve its oversight and sal. [...] • Provide FDA discretion in setting penalties to take into account the start a new company to evade • FDA cannot consider whether a company has nature, circumstances, extent, and gravity of the violations and any enforcement.