Talking Regulatory Issues With Mark LeDoux


Vitamin Retailer magazine asked Mark LeDoux, Chairman & CEO of Natural Alternatives International based in Carlsbad, CA (nai-online.com), for his take on three regulatory-related questions.

Here are his comments:

VR: What is the single biggest regulatory or enforcement problem that the natural products industry currently faces?

To some degree, the largest challenge in the regulatory or enforcement area of our industry is the glaring lack of in person inspections of production facilities, the apparent disdain of NDI enforcement of some form of protection for companies that have done the significant work of demonstrating new dietary ingredients as being safely made and safe for human consumption, and the apparent disinterest of the agencies tasked with consumer protection to proffer that they only will get involved with copy-cat products that cause injury or death.

That seems like a tacit endorsement of copy-cat products that have not undergone the statutory requirements associated with NDI filings and the corresponding amount of scientific and production data, not to mention toxicology data required under a careful reading of the NDI process.

Even when glaringly violative products are identified in commerce and brought to the attention of the agency it seems that a lack of interest in actual enforcement is now standard operating procedure.

This does little to embrace the construct and implementation of the Dietary Supplement Health and Education Act of 1994.

VR: What is the single-biggest problem or challenge that natural-product retailers now face?

The industry faces a myriad of challenges at the moment, but chief among them is the apparent reluctance of regulatory agencies such as the FDA from doing product seizures that are clearly violative of federal law.

To continue to allow ‘banned substances’ to be sold either in retail or online even when said products are brought to the agency’s attention by members of responsible industry, the lack of enforcement of the provisions of DSHEA and subsequent legislation does little to enhance public perception of the quality of products in the industry. It is seldom that an industry will need to ask for enforcement of key provisions of regulatory remedies embodied in federal legislation, and so the inaction by the agency tasked with implementation is truly remarkable.

VR: The FDA recently refused to reverse its position that NAC is not a dietary supplement but, at the same time, it has indicated that it does not plan to enforce against otherwise legally marketed NAC supplements. Please comment.

Primarily, the driving force in dealing with allowing materials to be permitted for consumer sale as dietary supplements should center on issues of product safety. The safety profile of n-acetyl l-cysteine has been demonstrated to be extremely safe, as it has been in use for several decades without a significant body of AERs on file (Adverse Event Reports).

I personally think the agency should continue to allow this life-giving supplement to be sold assuming the material presented meets monograph standards for safety, purity and identity, and that any efforts to restrict this material in light of some tortured explanation that an inhalation or intravenous solution containing the same compound was once declared an effective drug is something of an overreach.

Given the vast data in peer reviewed science supporting the role of glutathione in health management, particularly in the face of a multi-year pandemic, alone should suggest the agency turn its attention to other materials that have a paucity of safety data, and therefore should undergo additional scrutiny.

Feature

Vitamin Retailer magazine asked Mark LeDoux, Chairman & CEO of Natural Alternatives International based in Carlsbad, CA (nai-online.com), for his take on three regulatory-related questions.

Here are his comments:

VR: What is the single biggest regulatory or enforcement problem that the natural products industry currently faces?

To some degree, the largest challenge in the regulatory or enforcement area of our industry is the glaring lack of in person inspections of production facilities, the apparent disdain of NDI enforcement of some form of protection for companies that have done the significant work of demonstrating new dietary ingredients as being safely made and safe for human consumption, and the apparent disinterest of the agencies tasked with consumer protection to proffer that they only will get involved with copy-cat products that cause injury or death.

That seems like a tacit endorsement of copy-cat products that have not undergone the statutory requirements associated with NDI filings and the corresponding amount of scientific and production data, not to mention toxicology data required under a careful reading of the NDI process.

Even when glaringly violative products are identified in commerce and brought to the attention of the agency it seems that a lack of interest in actual enforcement is now standard operating procedure.

This does little to embrace the construct and implementation of the Dietary Supplement Health and Education Act of 1994.

VR: What is the single-biggest problem or challenge that natural-product retailers now face?

The industry faces a myriad of challenges at the moment, but chief among them is the apparent reluctance of regulatory agencies such as the FDA from doing product seizures that are clearly violative of federal law.

To continue to allow ‘banned substances’ to be sold either in retail or online even when said products are brought to the agency’s attention by members of responsible industry, the lack of enforcement of the provisions of DSHEA and subsequent legislation does little to enhance public perception of the quality of products in the industry. It is seldom that an industry will need to ask for enforcement of key provisions of regulatory remedies embodied in federal legislation, and so the inaction by the agency tasked with implementation is truly remarkable.

VR: The FDA recently refused to reverse its position that NAC is not a dietary supplement but, at the same time, it has indicated that it does not plan to enforce against otherwise legally marketed NAC supplements. Please comment.

Primarily, the driving force in dealing with allowing materials to be permitted for consumer sale as dietary supplements should center on issues of product safety. The safety profile of n-acetyl l-cysteine has been demonstrated to be extremely safe, as it has been in use for several decades without a significant body of AERs on file (Adverse Event Reports).

I personally think the agency should continue to allow this life-giving supplement to be sold assuming the material presented meets monograph standards for safety, purity and identity, and that any efforts to restrict this material in light of some tortured explanation that an inhalation or intravenous solution containing the same compound was once declared an effective drug is something of an overreach.

Given the vast data in peer reviewed science supporting the role of glutathione in health management, particularly in the face of a multi-year pandemic, alone should suggest the agency turn its attention to other materials that have a paucity of safety data, and therefore should undergo additional scrutiny.





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