NDI Submissions Fare Better With Early FDA Contact
This article was originally published in The Tan Sheet
FDA officials encourage firms to work with them before submitting notifications to ensure all necessary information is included, increasing a firm’s chance of success. Most NDI notifications the agency rejects have incomplete information, they say.
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FDA proposed “a pretty crazy” NDI notification draft guidance, says attorney Wes Siegner, because “they think everything is an NDI.” Other stakeholders acknowledge FDA wants tighter regulation of the industry, but say writing and imposing rules for supplement manufacturing is a two-way street.
USPlabs says it will reformulate its DMAA supplements, although it “stands by the safety and legality” of the products. FDA says “credible science” shows DMAA is not a botanical, not a dietary ingredient and will not be accepted in an NDI notification.
J&J reports worldwide consumer sales dipped 0.6% to $3.6 billion despite retailers buying more upper respiratory and analgesic products to prepare for the cough and cold season. But in key OTC categories the firm is regaining market share it lost when its iconic brands were temporarily not available.