{"id":15274,"date":"2019-05-29T15:53:21","date_gmt":"2019-05-29T15:53:21","guid":{"rendered":"https:\/\/www.nutracapusa.com\/?p=15274"},"modified":"2022-01-16T10:57:03","modified_gmt":"2022-01-16T10:57:03","slug":"fda-official-highlights-noncompliance-with-dietary-ingredient-requirement-enforcement-challenges","status":"publish","type":"post","link":"https:\/\/www.nutracapusa.com\/blog\/fda-official-highlights-noncompliance-with-dietary-ingredient-requirement-enforcement-challenges\/","title":{"rendered":"FDA official highlights noncompliance with dietary ingredient requirement, enforcement challenges"},"content":{"rendered":"\n\t\t\t\t\n

Only a small fraction of the ingredient notifications required under the Dietary Supplement Health and Education Act of 1994 (DSHEA) have been submitted to FDA since the 1990s, an agency official concluded during a May 16 public meeting<\/a>.<\/p>\n\n\n\n

Distributors and manufacturers must notify FDA, providing the agency evidence of safety 75 days before introducing a new dietary ingredient (NDI) into interstate commerce.<\/p>\n\n\n\n

Although many companies are suspected of neglecting to comply with the notification requirement, the director of FDA\u2019s Office of Dietary Supplement Programs (ODSP), Steven Tave, suggested his agency doesn\u2019t have a way to accurately measure all the NDIs that should have been submitted to FDA but were not.<\/p>\n\n\n\n

Part of FDA\u2019s challenge is the law exempted from the NDI notification (NDIN) requirement dietary ingredients marketed before Oct. 15, 1994, and those that have \u201cbeen present in the food supply as an article used for food in a form in which the food has not been chemically altered.\u201d<\/p>\n\n\n\n

Nonetheless, Tave calculated less than 25 percent of the required NDINs have been submitted to FDA. His conclusion is based, in part, on an estimated 50,000 dietary products on the market today. Tave\u2019s figure is at the low end of FDA\u2019s estimates of the current dietary supplement products on the market, which could number as high as 80,000.<\/p>\n\n\n\n

Only 4,000 products were on the market in 1994, according to Congress\u2019 estimates, so at least 46,000 new dietary supplement products have been introduced since 1994.<\/p>\n\n\n\n

Responding to criticism that companies have failed to comply with the NDIN requirement, industry sources have pointed out many new products are exempt from the NDIN requirement because they are, for example, combinations of old ingredients grandfathered under DSHEA.<\/p>\n\n\n\n

Tave acknowledged such exemptions were not subject to the NDIN requirement.<\/p>\n\n\n\n

\u201cLet\u2019s say 90 percent of these products did not require a notification,” he said. \u201cThat still leaves 10 percent of the products that did require a notification.\u201d<\/p>\n\n\n\n

That means the distributors or manufacturers of 4,600 products were obligated to notify FDA, providing evidence that their NDI is reasonably expected to be safe. However, only about 1,100 NDINs have been submitted to FDA since the law was signed, Tave reported.<\/p>\n\n\n\n

Tave noted people could \u201cquibble with the math,\u201d but he suggested the order of magnitude was correct.<\/p>\n\n\n\n

Read The Full Article<\/strong> HERE<\/a><\/p>\n\t\t","protected":false},"excerpt":{"rendered":"

Only a small fraction of the ingredient notifications required under the Dietary Supplement Health and Education Act of 1994 (DSHEA) have been submitted to FDA since the 1990s, an agency official concluded during a May 16 public meeting. Distributors and manufacturers must notify FDA, providing the agency evidence of safety 75 days before introducing a new…<\/p>\n","protected":false},"author":6,"featured_media":15275,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"content-type":"","footnotes":""},"categories":[37],"tags":[],"_links":{"self":[{"href":"https:\/\/www.nutracapusa.com\/wp-json\/wp\/v2\/posts\/15274"}],"collection":[{"href":"https:\/\/www.nutracapusa.com\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.nutracapusa.com\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.nutracapusa.com\/wp-json\/wp\/v2\/users\/6"}],"replies":[{"embeddable":true,"href":"https:\/\/www.nutracapusa.com\/wp-json\/wp\/v2\/comments?post=15274"}],"version-history":[{"count":1,"href":"https:\/\/www.nutracapusa.com\/wp-json\/wp\/v2\/posts\/15274\/revisions"}],"predecessor-version":[{"id":20286,"href":"https:\/\/www.nutracapusa.com\/wp-json\/wp\/v2\/posts\/15274\/revisions\/20286"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.nutracapusa.com\/wp-json\/wp\/v2\/media\/15275"}],"wp:attachment":[{"href":"https:\/\/www.nutracapusa.com\/wp-json\/wp\/v2\/media?parent=15274"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.nutracapusa.com\/wp-json\/wp\/v2\/categories?post=15274"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.nutracapusa.com\/wp-json\/wp\/v2\/tags?post=15274"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}