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JUNE: While a certain draft guidance document on new dietary ingredients (NDIs) has grabbed all of the headlines, it has not been the only issue keeping the sector’s regulatory affairs experts awake at night. Indeed, just days before the NDI guidance was issued in early July, Senator Dick Durbin (D-IL) unleashed The Dietary Supplement Labeling Act, a bill which was immediately attacked by the industry's trade associations as “misinformed and misguided”. The bill would direct the Food and Drug Administration (FDA) to define ‘conventional foods’, require manufacturers to register dietary supplement products to the FDA, require labels to disclose the known risks of ingredients and display a mandatory warning if the product contains a dietary ingredient that may cause potentially serious adverse events. But what’s happened to this bill? According to a spokeswoman at Sen. Durbin’s office, it remains with the Committee on Health, Education, Labor, and Pensions. “Senator Durbin is committed to the legislation and would like to see bipartisan support. The next steps would be holding a hearing (unfortunately, Senator Durbin is not on the Senate HELP Committee though) and /or moving this bill on its own or as a part of a larger piece of legislation. “ Click here for details. |
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Apocalypse now? FDA unveils draft guidance on new dietary ingredients (NDIs) |
Phytosterols, health claims, and ‘arbitrary and capricious decision making’ |
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While a certain draft guidance document on new dietary ingredients (NDIs) has grabbed all of the headlines, it has not been the only issue keeping the sector’s regulatory affairs experts awake at night.
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