Joanna Cosgrove, Online Editor01.02.12
The publication of FDA’s New Dietary Ingredient (NDI) Notification Guidance draft was the single most defining story in the supplement industry in 2011. With the end of the official comment period ending about a month ago, FDA has asked industry members to be patient as it sorts through an estimated 146,000 pages of comments.
The anticipation of what lies ahead was the subject of a webinar organized recently by the United Natural Products Association, which featured Dr. Daniel Fabricant, director of dietary supplement programs at FDA, as its sole speaker.
Early in his presentation, Dr. Fabricant defended the merits of the NDI Notification process, pointing to the product volume growth in the supplement industry. “There were 4000 products when DSHEA [Dietary Supplement Health and Education Act] passed,” he said. “At present, there are roughly 55,600 dietary supplement products on the market, and the Institute of Medicine has estimated that 1000 new dietary supplements are introduced to the market each year, yet FDA has only received approximately 730 NDI notifications since we began reviewing NDI notifications some 16 years ago.”
“Consumers should have access to dietary supplements that are safe, meet quality standards, that are free from contamination and are accurately labeled,” he continued. “FDA’s review of NDI notifications is an important preventive control mechanism to ensure that the consumer is not exposed to unnecessary public health risks in the form of new ingredients with unknown safety profiles.”
Dr. Fabricant acknowledged that FDA has been “wrestling” with many questions raised in the comments, including calls for the withdrawal of the guidance altogether. Last month the American Herbal Products Association (AHPA) levied its criticism, calling for the agency to withdraw the “hugely flawed” Notification Guidance and issue a new guidance that ensured consistency with DSHEA.
“Instead of providing guidance regarding DSHEA’s NDI notification provision, as directed by section 113(b) of the Food Safety Modernization Act (FSMA), the draft guidance seeks to erect extra-legal barriers to market entry, impose food additive- and pharmaceutical-type evaluative criteria, require multiple NDI notifications for dietary supplements beyond those required by law, and transform the legal requirements for marketing of dietary supplements that contain NDIs from the notification process described under law to an FDA approval process,” AHPA wrote.
AHPA maintained that instead of facilitating compliance with the NDI provision of the law, the draft guidance would, if implemented as written with the flaws identified, change the rules that have been in place for the last 17 years and significantly increase the burden on the supplement industry far beyond the intent of Congress with no concomitant benefit for consumers.
A key area of concern in the draft guidance for AHPA is FDA’s call for multiple NDI filings of the same dietary ingredient. “AHPA believes that separate notifications are not required when the initial notification filed for the NDI provides a description of a dietary supplement or a range of dietary supplements that would include the NDI,” the association said. “FDA’s actual practice has been to file without objection premarket notifications that describe the NDI specifically but that only generally describe dietary supplements that will contain the dietary ingredient.”
In addition, “FDA proposes that manufacturers must establish the pedigrees of all old dietary ingredients they use and submit NDI notifications where required for each supplement containing new dietary ingredients,” AHPA said. “The draft guidance would require these notifications to be supported by safety documentation meeting food additive petition requirements, the very requirements DSHEA struck out of the dietary supplement paradigm.”
“AHPA’s view is that this section goes far beyond the intent of the law and is wholly unnecessary and inappropriate in many cases to establish a reasonable expectation of safety,” said Michael McGuffin, AHPA president, noting that in conjunction with its criticism, AHPA also proposed solutions described as being “lawful-starting point[s] for revised guidance.”
“Let me be clear, AHPA has called for FDA to remove the guidance,” Mr. McGuffin asserted. “Nonetheless, we believe there would be a benefit for FDA to offer guidance that doesn’t rewrite the law and that companies that do have NDIs would find useful.”
Other draft guidance comments called for an even stronger approach. Dr. Fabricant spoke about four framework modifications that were suggested in the hopes of ensuring the expectation of safety. “Historical use should rarely, if ever, be sufficient to replace experimental data; entirely novel ingredients should undergo, at a minimum, 90-day human testing; manufacturers should be required to submit to the FDA all available data regarding new ingredients, both favorable and unfavorable; and before assuming that consumers follow instructions on supplement labels, this assumption should be confirmed empirically,” he said. “Absent significant modification, the FDA’s guidance may have the effect of providing a false sense of security to consumers seeking safe dietary supplements.”
A comment in favor of stronger transparency that Dr. Fabricant included in his presentation was this one: “Consumers would probably be very alarmed to learn that synthetic chemical ingredients…can be introduced as components of dietary supplements with no formal safety review or notice to FDA. In light of these serious health concerns, Consumer Union supports FDA initiatives intended to bring more transparency and accountability to the dietary supplement market. The present New Dietary Ingredient Notification Guidance is critical, because it gives manufacturers much-needed clarification as to whether they need to notify the FDA regarding certain supplement products. Without this guidance, many potentially harmful products may reach the market without FDA notification.”
Now that the comment period has ended, Dr. Fabricant mused on how FDA would go about “eating the elephant, one bite at a time.”
“The key thing is that it is a draft Guidance…that represents the agency’s current thinking,” Dr. Frabricant stressed. “The agency is more than willing to discuss alternative approaches just as long as it conforms to statutes and regulations.
“Regardless of what people think of the Guidance, there’s a statutory obligation there,” he added. “Compliance to the statutes and regulations is really the industry’s responsibility. There’s a lot of focus on the guidance, maybe some of that energy may be better spent meeting the statute and complying with everything in the statute and regulations.”
Dr. Fabricant concluded his presentation by repeating that while his timeline for slogging through to the bottom of the comment pile is “up in the air,” he reaffirmed the overarching goal of FDA’s review of NDI notifications to be “an important preventive control mechanism to ensure that the consumer is not exposed to unnecessary public health risks in the form of new ingredients with unknown safety profiles.”
To view previous NDI notifications and FDA responses Dr. Fabricant suggested logging onto this website and entering Docket FDA-1995-S-0039. For questions about a notification, contact the NDI Consumer Safety Office or call 240-402-1756.
The anticipation of what lies ahead was the subject of a webinar organized recently by the United Natural Products Association, which featured Dr. Daniel Fabricant, director of dietary supplement programs at FDA, as its sole speaker.
Early in his presentation, Dr. Fabricant defended the merits of the NDI Notification process, pointing to the product volume growth in the supplement industry. “There were 4000 products when DSHEA [Dietary Supplement Health and Education Act] passed,” he said. “At present, there are roughly 55,600 dietary supplement products on the market, and the Institute of Medicine has estimated that 1000 new dietary supplements are introduced to the market each year, yet FDA has only received approximately 730 NDI notifications since we began reviewing NDI notifications some 16 years ago.”
“Consumers should have access to dietary supplements that are safe, meet quality standards, that are free from contamination and are accurately labeled,” he continued. “FDA’s review of NDI notifications is an important preventive control mechanism to ensure that the consumer is not exposed to unnecessary public health risks in the form of new ingredients with unknown safety profiles.”
Dr. Fabricant acknowledged that FDA has been “wrestling” with many questions raised in the comments, including calls for the withdrawal of the guidance altogether. Last month the American Herbal Products Association (AHPA) levied its criticism, calling for the agency to withdraw the “hugely flawed” Notification Guidance and issue a new guidance that ensured consistency with DSHEA.
“Instead of providing guidance regarding DSHEA’s NDI notification provision, as directed by section 113(b) of the Food Safety Modernization Act (FSMA), the draft guidance seeks to erect extra-legal barriers to market entry, impose food additive- and pharmaceutical-type evaluative criteria, require multiple NDI notifications for dietary supplements beyond those required by law, and transform the legal requirements for marketing of dietary supplements that contain NDIs from the notification process described under law to an FDA approval process,” AHPA wrote.
AHPA maintained that instead of facilitating compliance with the NDI provision of the law, the draft guidance would, if implemented as written with the flaws identified, change the rules that have been in place for the last 17 years and significantly increase the burden on the supplement industry far beyond the intent of Congress with no concomitant benefit for consumers.
A key area of concern in the draft guidance for AHPA is FDA’s call for multiple NDI filings of the same dietary ingredient. “AHPA believes that separate notifications are not required when the initial notification filed for the NDI provides a description of a dietary supplement or a range of dietary supplements that would include the NDI,” the association said. “FDA’s actual practice has been to file without objection premarket notifications that describe the NDI specifically but that only generally describe dietary supplements that will contain the dietary ingredient.”
In addition, “FDA proposes that manufacturers must establish the pedigrees of all old dietary ingredients they use and submit NDI notifications where required for each supplement containing new dietary ingredients,” AHPA said. “The draft guidance would require these notifications to be supported by safety documentation meeting food additive petition requirements, the very requirements DSHEA struck out of the dietary supplement paradigm.”
“AHPA’s view is that this section goes far beyond the intent of the law and is wholly unnecessary and inappropriate in many cases to establish a reasonable expectation of safety,” said Michael McGuffin, AHPA president, noting that in conjunction with its criticism, AHPA also proposed solutions described as being “lawful-starting point[s] for revised guidance.”
“Let me be clear, AHPA has called for FDA to remove the guidance,” Mr. McGuffin asserted. “Nonetheless, we believe there would be a benefit for FDA to offer guidance that doesn’t rewrite the law and that companies that do have NDIs would find useful.”
Other draft guidance comments called for an even stronger approach. Dr. Fabricant spoke about four framework modifications that were suggested in the hopes of ensuring the expectation of safety. “Historical use should rarely, if ever, be sufficient to replace experimental data; entirely novel ingredients should undergo, at a minimum, 90-day human testing; manufacturers should be required to submit to the FDA all available data regarding new ingredients, both favorable and unfavorable; and before assuming that consumers follow instructions on supplement labels, this assumption should be confirmed empirically,” he said. “Absent significant modification, the FDA’s guidance may have the effect of providing a false sense of security to consumers seeking safe dietary supplements.”
A comment in favor of stronger transparency that Dr. Fabricant included in his presentation was this one: “Consumers would probably be very alarmed to learn that synthetic chemical ingredients…can be introduced as components of dietary supplements with no formal safety review or notice to FDA. In light of these serious health concerns, Consumer Union supports FDA initiatives intended to bring more transparency and accountability to the dietary supplement market. The present New Dietary Ingredient Notification Guidance is critical, because it gives manufacturers much-needed clarification as to whether they need to notify the FDA regarding certain supplement products. Without this guidance, many potentially harmful products may reach the market without FDA notification.”
Now that the comment period has ended, Dr. Fabricant mused on how FDA would go about “eating the elephant, one bite at a time.”
“The key thing is that it is a draft Guidance…that represents the agency’s current thinking,” Dr. Frabricant stressed. “The agency is more than willing to discuss alternative approaches just as long as it conforms to statutes and regulations.
“Regardless of what people think of the Guidance, there’s a statutory obligation there,” he added. “Compliance to the statutes and regulations is really the industry’s responsibility. There’s a lot of focus on the guidance, maybe some of that energy may be better spent meeting the statute and complying with everything in the statute and regulations.”
Dr. Fabricant concluded his presentation by repeating that while his timeline for slogging through to the bottom of the comment pile is “up in the air,” he reaffirmed the overarching goal of FDA’s review of NDI notifications to be “an important preventive control mechanism to ensure that the consumer is not exposed to unnecessary public health risks in the form of new ingredients with unknown safety profiles.”
To view previous NDI notifications and FDA responses Dr. Fabricant suggested logging onto this website and entering Docket FDA-1995-S-0039. For questions about a notification, contact the NDI Consumer Safety Office or call 240-402-1756.
