02.10.22
In the ongoing deliberation over the legal status of N-acetyl cysteine (NAC) as a dietary ingredient, the United Natural Products Alliance (UNPA) has submitted additional evidence of the ingredient’s use in dietary products to the U.S. Food and Drug Administration (FDA)’s Office of Dietary Supplement Programs. The evidence was submitted on January 25, after the organization’s NAC working group undertook a search for histories of sale, marketing, and manufacturing of NAC.
Beginning last year, the agency took issue with the ingredient’s use in warning letters to several companies marketing the ingredient, noting the ingredient was used in a drug marketed as Mucomyst in 1963, prior to the the Dietary Supplement Health and Education Act (DSHEA) of 1994. However, evidence has been provided by several trade associations, including the American Herbal Products Association, Council for Responsible Nutrition, and Natural Products Association, showing the use of NAC as a dietary ingredient prior to DSHEA’s passage. A provision of DSHEA allows for dietary supplement ingredients to be “grandfathered” into legal status if they were legally marketed as such prior to the legislation’s passage.
“Our efforts were fruitful and as a result, a number of relevant documents were found that established, in UNPA’s opinion, definitive sale of NAC as a dietary ingredient prior to the October 15, 1994 grandfather date,” UNPA said.
Members of the UNPA NAC working group included: Arizona Nutritional Supplements; American Association of Naturopathic Physicians; Bastyr University; FDA Compliance Simplified; Holistic Primary Care; NOW Foods; and Ortho Molecular.
“We want to thank all of the volunteers of the NAC working group for their efforts and contributions,” said Larisa Pavlick, vice president of global regulatory and compliance for UNPA. “We provided critical documentation to the FDA regarding NAC as a supplement. This project was a challenge after so many years have passed since DSHEA.”
UNPA provided a statement of its position on the matter. It asserted that FDA is acting outside of its statutory jurisdiction and authority in attempting to exclude NAC from the dietary supplement market. It is also of the position that there is definitive evidence of pre-DSHEA use of NAC, that NAC is safe, and that these points are broadly agreed upon. It also said that it will continue to pursue the issue “until a proper outcome is reached, which is recognition of NAC as a lawful ODI [Old Dietary Ingredient as defined by DSHEA] and FDA abandons its misguided retro lookback policy.”
Beginning last year, the agency took issue with the ingredient’s use in warning letters to several companies marketing the ingredient, noting the ingredient was used in a drug marketed as Mucomyst in 1963, prior to the the Dietary Supplement Health and Education Act (DSHEA) of 1994. However, evidence has been provided by several trade associations, including the American Herbal Products Association, Council for Responsible Nutrition, and Natural Products Association, showing the use of NAC as a dietary ingredient prior to DSHEA’s passage. A provision of DSHEA allows for dietary supplement ingredients to be “grandfathered” into legal status if they were legally marketed as such prior to the legislation’s passage.
“Our efforts were fruitful and as a result, a number of relevant documents were found that established, in UNPA’s opinion, definitive sale of NAC as a dietary ingredient prior to the October 15, 1994 grandfather date,” UNPA said.
Members of the UNPA NAC working group included: Arizona Nutritional Supplements; American Association of Naturopathic Physicians; Bastyr University; FDA Compliance Simplified; Holistic Primary Care; NOW Foods; and Ortho Molecular.
“We want to thank all of the volunteers of the NAC working group for their efforts and contributions,” said Larisa Pavlick, vice president of global regulatory and compliance for UNPA. “We provided critical documentation to the FDA regarding NAC as a supplement. This project was a challenge after so many years have passed since DSHEA.”
UNPA provided a statement of its position on the matter. It asserted that FDA is acting outside of its statutory jurisdiction and authority in attempting to exclude NAC from the dietary supplement market. It is also of the position that there is definitive evidence of pre-DSHEA use of NAC, that NAC is safe, and that these points are broadly agreed upon. It also said that it will continue to pursue the issue “until a proper outcome is reached, which is recognition of NAC as a lawful ODI [Old Dietary Ingredient as defined by DSHEA] and FDA abandons its misguided retro lookback policy.”
