12.07.20
The Council for Responsible Nutrition (CRN), a dietary supplement trade association, recently responded to two pending issues taking place at the federal level which will likely have ramifications for the entire dietary supplements industry.
First, CRN submitted a response to the U.S. Food and Drug Administration (FDA) regarding warning letters the agency issued, which stated its position that N-acetyl-L-cysteine (NAC) is not a dietary supplement. Secondly, the U.S. Department of Health and Human Services (HHS) recently proposed a new rule which would establish a plan for HHS and the agencies under it to periodically review existing regulations and amend or rescind those that are “duplicative, outdated, or overly burdensome.”
CRN: ‘Revert the NAC Policy’
On Dec. 4, the trade association submitted a response to FDA regarding warning letters it sent out, stating its position that NAC is not a dietary supplement. CRN asked the FDA to reverse a recently-adopted position that manufacturers are prohibited from marketing NAC-containing products as dietary supplements, claiming that this policy is legally invalid. FDA had a longstanding policy of allowing manufacturers to market NAC-containing products as dietary supplements for decades, until July 2020.
“In fact, FDA has considered over 100 structure-function claim notifications regarding NAC, and at least one qualified health claim petition for a dietary supplement containing NAC, and has not objected to the presence of NAC in any of these products,” Steve Mister, president and CEO of CRN, wrote.
FDA’s position on the matter was that NAC was approved as a new drug in 1963, and, to the agency’s knowledge, was not marketed as a dietary supplement prior. “FDA has failed to provide any rationale for this policy change other than the basic assertions made in these warning letters,” though, according to Mister.
According to Mister, the documentation for the decades-old NAC drug approval contain unreliable information, such as handwritten dates, and unverifiable information. Additionally, NAC drugs approved prior to 2016 are comprised of different forms of NAC than which is found in dietary supplements, Mister said.
CRN’s full response to the warning letters can be viewed here.
New HHS Proposal
In a letter submitted to the U.S. Department of Health and Human Services, CRN addressed a number of concerns it has with a proposed HHS rule, “Securing Updated and Necessary Statutory Evaluations Timely,” which would allow all agencies under the auspices of the department to periodically review their regulations, as well as to set expiration dates for its regulations, subject to certain exceptions, unless the regulations are found to be subject to the Regulatory Flexibility Act.
“CRN supports regulatory reform and values opportunities to review and modernize regulations to ensure that they are no more burdensome than necessary,” Mister wrote. “We applaud HHS’s efforts to take another look at the regulatory review process and consider ways to improve it. However, we have significant concerns about the expansive and accelerated approach taken in the proposed rule. In general, CRN is concerned that the suggested approach would require intense work from FDA that would not only take critical agency resources and experience away from managing the COVID-19 pandemic and routine agency activities, but also would not allow for the kind of targeted and reasoned regulatory reform that is necessary and appropriate.”
“Further, we are concerned that there is a genuine potential that the Proposed Rule could lead to the inadvertent sunsetting of regulations that have been in place for many years and are essential to maintaining consumer confidence in our nation’s food supply, including dietary supplements, as well as a level playing field within the industry,” Mister continued. “Abandoning these rules of law has the potential to breed chaos, confusion, and distrust that could irreparably harm regulated industry and the benefitting public alike.”
The five main qualms that CRN had with the proposed rule were that it should provide greater clarity about how sunset exceptions will function, that it should outline the process behind how reviews would be conducted, that the proposed rule has an unrealistic timeline, that there are no guarantees necessary regulations will be reviewed in a timely manner, and that the use of machine learning in regulatory reform is a novel approach and members of the public will not have an opportunity to comment on its use.
CRN’s full response to the HHS proposal can be viewed here.
First, CRN submitted a response to the U.S. Food and Drug Administration (FDA) regarding warning letters the agency issued, which stated its position that N-acetyl-L-cysteine (NAC) is not a dietary supplement. Secondly, the U.S. Department of Health and Human Services (HHS) recently proposed a new rule which would establish a plan for HHS and the agencies under it to periodically review existing regulations and amend or rescind those that are “duplicative, outdated, or overly burdensome.”
CRN: ‘Revert the NAC Policy’
On Dec. 4, the trade association submitted a response to FDA regarding warning letters it sent out, stating its position that NAC is not a dietary supplement. CRN asked the FDA to reverse a recently-adopted position that manufacturers are prohibited from marketing NAC-containing products as dietary supplements, claiming that this policy is legally invalid. FDA had a longstanding policy of allowing manufacturers to market NAC-containing products as dietary supplements for decades, until July 2020.
“In fact, FDA has considered over 100 structure-function claim notifications regarding NAC, and at least one qualified health claim petition for a dietary supplement containing NAC, and has not objected to the presence of NAC in any of these products,” Steve Mister, president and CEO of CRN, wrote.
FDA’s position on the matter was that NAC was approved as a new drug in 1963, and, to the agency’s knowledge, was not marketed as a dietary supplement prior. “FDA has failed to provide any rationale for this policy change other than the basic assertions made in these warning letters,” though, according to Mister.
According to Mister, the documentation for the decades-old NAC drug approval contain unreliable information, such as handwritten dates, and unverifiable information. Additionally, NAC drugs approved prior to 2016 are comprised of different forms of NAC than which is found in dietary supplements, Mister said.
CRN’s full response to the warning letters can be viewed here.
New HHS Proposal
In a letter submitted to the U.S. Department of Health and Human Services, CRN addressed a number of concerns it has with a proposed HHS rule, “Securing Updated and Necessary Statutory Evaluations Timely,” which would allow all agencies under the auspices of the department to periodically review their regulations, as well as to set expiration dates for its regulations, subject to certain exceptions, unless the regulations are found to be subject to the Regulatory Flexibility Act.
“CRN supports regulatory reform and values opportunities to review and modernize regulations to ensure that they are no more burdensome than necessary,” Mister wrote. “We applaud HHS’s efforts to take another look at the regulatory review process and consider ways to improve it. However, we have significant concerns about the expansive and accelerated approach taken in the proposed rule. In general, CRN is concerned that the suggested approach would require intense work from FDA that would not only take critical agency resources and experience away from managing the COVID-19 pandemic and routine agency activities, but also would not allow for the kind of targeted and reasoned regulatory reform that is necessary and appropriate.”
“Further, we are concerned that there is a genuine potential that the Proposed Rule could lead to the inadvertent sunsetting of regulations that have been in place for many years and are essential to maintaining consumer confidence in our nation’s food supply, including dietary supplements, as well as a level playing field within the industry,” Mister continued. “Abandoning these rules of law has the potential to breed chaos, confusion, and distrust that could irreparably harm regulated industry and the benefitting public alike.”
The five main qualms that CRN had with the proposed rule were that it should provide greater clarity about how sunset exceptions will function, that it should outline the process behind how reviews would be conducted, that the proposed rule has an unrealistic timeline, that there are no guarantees necessary regulations will be reviewed in a timely manner, and that the use of machine learning in regulatory reform is a novel approach and members of the public will not have an opportunity to comment on its use.
CRN’s full response to the HHS proposal can be viewed here.
