For almost 2 decades, industry
organizations, nonprofit groups, and other interested parties have been calling
for clarification from the US Food and Drug Administration (FDA) regarding the new
dietary ingredient (NDI) provision of the Dietary Supplement Health and
Education Act of 1994 (DSHEA). With the passage of the Food Safety
Modernization Act (FSMA) on January 4, 2011—17 years after the passage of DSHEA—FDA
became legally bound to publish guidance explaining the NDI provision. On
behalf of the industry, Sen. Orrin Hatch (R-UT) proposed a 180-day deadline for
FDA to publish its long-awaited clarification of this important, but ambiguous,
portion of DSHEA. The statutory language and
complexity of issues associated with the NDI provision—sometimes referred to as
Section 8 of DSHEA—makes it difficult to interpret and understand, even by
lawyers and regulatory experts. ABC Founder and Executive Director Mark
Blumenthal noted this in ABC’s formal comments submitted to FDA in 2005,
following a public meeting on the subject the previous year. “ABC has been
concerned that industry, media, health professionals, and other areas of the
general public have not adequately understood or appreciated the significance
of Section 8 of DSHEA, the New Dietary Ingredient provision,” he wrote.1 On July 1, 2011, just days before
the FSMA deadline, FDA released a draft guidance document designed to clarify
the NDI process. However, many of the original concerns of ABC and other
parties were not adequately addressed, and industry trade organizations are
generally displeased with the document. Marc Ullman, of Ullman, Shapiro &
Ullman, LLC, a firm that specializes in food and drug law, called the draft
guidance document “unfortunately myopic” and “fatally flawed” in comments
submitted to FDA in August 2011.2
In December of 2011, trade
associations, nonprofit organizations including the American Botanical Council
(ABC), dietary supplement businesses, and Sens. Hatch and Tom Harkin (D-IA)—the
principle authors of DSHEA—collectively called for the FDA’s draft guidance
document to be withdrawn and rewritten, citing sections that are contrary to
the original intent of Congress in passing DSHEA and questioning the document’s
legality. In an authoritative letter to FDA
Commissioner of Food and Drugs Margaret Hamburg, MD, Sens. Hatch and Harkin
suggested the draft guidance would create “substantial, additional costs on
manufacturers without providing additional safety benefits, and would undermine
the access to safe, affordable dietary supplement products that DSHEA was
designed to ensure.”3 Other notable groups that filed
comments include the National College of Natural Medicine (NCNM), the American
Association of Naturopathic Physicians (AANP), and the 5 dietary supplement
trade associations—the American Herbal Products Association (AHPA), the
Consumer Healthcare Products Association (CHPA), the Council for Responsible
Nutrition (CRN), the Natural Products Association (NPA), and the United Natural
Products Alliance (UNPA). According to AHPA, which
submitted 75 pages of comments, the draft guidance will simply not suffice.
“[I]f implemented as written … [the draft guidance would] change the rules that
have been in place for the last 17 years and significantly increase the burden
on the supplement industry,” wrote AHPA President Michael McGuffin.4 Existing Regulations
According to Section 8 of DSHEA,
manufacturers and distributors of dietary ingredients not marketed before the
passage of DSHEA on October 15, 1994—and
not present in the food supply in a form in which the food has not been
chemically altered—are required to notify FDA at least 75 days before
introducing the ingredient to the market.5 The notification must
contain adequate information to demonstrate a reasonable expectation of safety
of the new dietary ingredient under ordinary or labeled conditions of use for the
dietary supplement. (Ingredients sold prior to this date are often unofficially
referred to as “grandfathered” or “old dietary ingredients” [ODIs].) DSHEA created a new safety
standard for dietary ingredients used in supplements. Under the law, FDA may deem
a product adulterated—and therefore illegal—if it does not meet one of the
following 2 requirements: (1) “The dietary supplement contains only dietary ingredients which
have been present in the food supply as an article used for food in a form in
which the food has not been chemically altered.” (2) “There is a history of use or other evidence of safety
establishing that the dietary ingredient when used under the conditions
recommended or suggested in the labeling of the dietary supplement will
reasonably be expected to be safe; and … the manufacturer or distributor of the
dietary ingredient or dietary supplement provides the FDA with information,
including any citation to published articles, which is the basis on which the
manufacturer or distributor has concluded that a dietary supplement containing
such dietary ingredient will reasonably expected to be safe.”5 If a new dietary ingredient is not present in the food supply as an
article used for food in a form in which the food has not been chemically
altered, the manufacturer or distributor of the ingredient must submit notification
to FDA along with data establishing the NDI’s safety (that is, that the NDI
will reasonably be expected to be safe when used under conditions of use
recommended in labeling for the dietary supplement or under ordinary conditions
of use). Claire Kruger, PhD, of Spherix, a
health products consulting firm, offered examples of tests that could help
satisfy this requirement in a September 2011 presentation hosted by Natural Products Insider (NPI). “[A]nimal studies offer a
well-controlled atmosphere,” she suggested. “Other options include a
genotoxicity battery; repeat dose toxicity; chronic/carcinogenicity;
reproductive, developmental/teratology, and absorption, distribution,
metabolism, and elimination (ADME) studies.”6
The Cost of RegulationA special report published in
November 2011 by NPI looked at the
industry’s general understanding of the draft guidance document. Forty-four
percent of the 217 respondents identified themselves as supplement
manufacturers/marketers, followed by 23% who considered themselves ingredient
suppliers.7 Out of 7 possible areas of concern, survey respondents (82%)
were most concerned with the cost of compliance. According to Dr. Kruger, who
spoke at UNPA’s 2-day NDI seminary in June 2011, study expenses can range from
approximately $6,000 for a genetic toxicity battery to more than half a million
dollars for a multi-generation rodent reproductive study.8 Extensive
rodent studies, however, are usually needed only in cases where there is virtually
no pre-existing safety data. Some say the added costs of these
studies could lead to adverse consequences for the industry as well as consumers.
“This would lead to higher consumer prices, reduced variety of product choices,
contraction of jobs and innovation, and would foster an inequitable competitive
environment between manufacturers,” wrote UNPA Executive Director Loren
Israelsen in his organization’s 2011 comments to FDA.9 However, FDA
expects that these safety studies should already have been conducted by the
company, as the law states that manufacturers must ensure the safety of their
product. Therefore, FDA does not take these study costs into consideration. According to the most recent
figures available, FDA has received approximately 700 NDI notifications since
the passage of DSHEA in 1994. This figure, which FDA officials have suggested
represents a relatively low level of compliance, has been explained by some
industry members as a result of general confusion surrounding the NDI provision
and also on the potential cost of acceptable safety tests.10 “FDA has stated its view that
there is only a ‘minimum burden’ on companies that need to generate data to
meet the requirement to submit a NDI notification,” McGuffin noted. “The agency
explains its rationale for this evaluation by ignoring any effort required to
develop the information on which a NDI manufacturer or distributor has based
its conclusion that a dietary supplement that contains the NDI will reasonably
expected to be safe.”4
According to FDA, the agency is
working to address what is currently a relatively low level of adherence to the
NDI provision in DSHEA. “The agency is working hard to both develop new ideas
and enhance our current capabilities with respect to enforcement, deterrence
and promoting compliance, including NDI notifications,” said Daniel Fabricant, PhD,
Director of FDA’s Division of Dietary Supplements, in a July 2011 article in
SupplySide’s Supplements Community Wrap-Up.10 “However, with that stated, this
is a guidance, it does not convey any new binding authority to the agency, it
only clarifies our thinking on the topic. Should there be increased
enforcement/regulatory action on NDIs, it would simply be coincidental,” Dr.
Fabricant added. Old or New? One of the most basic concerns of
industry leaders is the lack of an FDA-approved list of ODIs. Without such a
list, determining which ingredients are NDIs is becoming exceedingly difficult.
Seventy-five percent of respondents to the NPI
survey said they were “very/a lot concerned about requirements to prove an
‘Old Dietary Ingredient.’”6 Notwithstanding FDA’s draft
guidance, under DSHEA a company is not legally required to prove to FDA that a
dietary ingredient is an ODI prior to marketing. Dietary supplement companies
(manufacturers, marketers, and distributors) should be prepared, however, to
defend the regulatory status of dietary ingredients (and other ingredients)
used in their dietary supplements. Companies must exercise due diligence prior
to marketing to fully vet the ODI vs. NDI issues. In the event that FDA pursues
an enforcement action against a company asserting that a dietary supplement is
adulterated because it contains an NDI for which there is inadequate
information to provide reasonable assurance that the ingredient does not
present a significant or unreasonable risk of illness or injury, the government
will bear the burden of proof to show that the dietary supplement is adulterated
under DSHEA. At the time of DSHEA’s enactment,
there was a general assumption that dietary ingredients sold before DSHEA’s
passage were considered to be safe based on widespread consumer use. “That’s not to say FDA couldn’t remove one of
those ingredients from the marketplace; but, to do so, the burden would be on
the agency,” wrote CRN President Steve Mister in a July 2011 NPI article. “And if FDA could
demonstrate a product carried ‘an unreasonable or significant risk of injury of
illness,’ it could remove that product from the market. FDA did just that with
ephedra.”11 Now, it seems, the agency is
attempting to shift the burden of proof to the industry. According to Dr. Fabricant, “There needs to be independent,
verifiable evidence that the article itself has been offered for sale in the US
as a dietary supplement pre-DSHEA. (Examples: catalogs, price lists, business
records [e.g., invoices, shipping records, bills-of-lading]; and
advertisements).”9 However, almost 17 years after the passage of
DSHEA, these paper documents are often not readily available or accessible and,
with each year, continue to disappear.
A comprehensive list of ODIs was
published in 1999 by the Utah Natural Products Alliance (now UNPA), which
encompassed lists from AHPA, CRN, and the National Nutritional Foods
Association (now NPA). Although FDA rejected the list as authoritative and
failed to give it legal effect, ABC recommended in its December 2011 comments
that an expert panel could help address list discrepancies and other industry
and FDA concerns. Such a list, it was suggested, should be amendable for
ingredients that can demonstrate ODI status in the future, even if not included
in the original list. (One legal expert reviewer of this article noted that in
many cases, these lists are too generic and do not take into account potential chemical
alteration and processing differences among the ingredients; hence, any list
which members of industry would want to be viable and possibly officially
recognized would probably have to be specific to the actual ingredient(s) being
used—not simply the generic term for such an ingredient.)Ingredients Versus Supplements Some members of the dietary
supplement industry were also surprised at the guidance document’s insistence
on submitting notifications for all supplements
containing an NDI, even if the supplement contains an NDI included in a
pre-existing FDA notification, and all the other dietary ingredients in the product
were marketed prior to October 15, 1994. Seventy-three percent of respondents
to the NPI survey were very concerned
“about the restrictive definition of ‘dietary ingredient’ and the need to file
for each finished product rather than for each ingredient.”7 “It seems that a NDI notification
must be submitted to FDA for each individual formula that contains the NDI,”
wrote Shaheen Majeed and Benoit LeGall in their comments from Sabinsa
Corporation, a manufacturer of botanical extracts. “This not only places a tremendous
burden on ingredient and finished product manufacturers, but it will constitute
an unmanageable burden on the Agency, potentially undermining the Agency’s
ability to act on more pressing regulatory issues such as adulteration.”12
In comments filed jointly, CRN
and CHPA also criticized the assumed practicality of requiring notifications
for each individual supplement containing an NDI. “Such a policy is not
grounded in practical realities or science,” they wrote. “And it would result
in industry members submitting burdensome and duplicative notifications that
waste both industry and agency resources without providing any consumer safety
benefit.”13 (However, a reviewer of this article noted that FDA has
already commented that NDI applications that cover the NDI used in a range of
doses, intended uses, and with a range of combinations of ingredients are acceptable.) AHPA—a leader in industry
discussions of NDIs—maintains a database of NDI notifications online; however, there is no seal of approval for any ingredient or
supplement that “passes” the inspection (i.e., that receives a letter of no
objection from FDA). “FDA states that each NDI submission is applicable and
specific to the submitter. Other companies intending to market the same
ingredient would have to submit their own NDI submission,” wrote Chris and
Patrick Noonan in a 2004 HerbalGram article
marking the 10th anniversary of DSHEA’s passage. “In other words,
there are no generic submissions that will benefit all other companies using
the same ingredient.” 14
Jon Benninger, vice president of
business development for the Health & Nutrition Network at Virgo Publishing,
believes there are some exceptions. According to an NPI article, Benninger said that “Dietary supplements that stay
within the defined parameters (conditions of uses, formulation definitions,
etc.) of a NDI notification submitted by the ingredient supplier DO NOT have to
submit their own notification. Just to be clear, this would only apply to a
dietary supplement that contains the exact ingredient that is subject of the
NDI notification. … Also, the conditions of use recommended or suggested in the
labeling of the dietary supplement must not be different from those conditions
of use stated in the NDI notification.”15Still, members of the industry
are not satisfied with FDA’s interpretation of the statute. Industry
representatives maintain that the massive amount of NDI notifications that need
to be filed could ultimately result in products being pulled from the market. “If industry took FDA’s directive
and literally began filing NDIs on all these ‘new’ ingredients, it could
overwhelm the agency,” wrote Mister. “[It could] result in trusted ingredients
with strong safety records being removed from the market until FDA reviews the
notice and responds.”16 Chemical Alteration and Solvents In addition to industry’s general
concerns, questions have also been raised about the statute’s definition and
meaning of “chemically altered.” This term is defined in the Statement of
Agreement, which, according to the chief sponsors of DSHEA, comprises the
entire legislative history for the bill. “Chemically altered” is defined by
what is not included, namely, the following physical
modifications: minor loss of volatile components, dehydration, lyophlization
(freeze-drying), milling, tincture or solution in water, slurry, powder, or
solid in suspension.”5 If an ingredient is “chemically
altered,” even if it was marketed in a more basic form (e.g., a whole herb
powder or an herbal tincture) before October 15, 1994, the manufacturer or
supplier of the ingredient is required to submit a notification and safety data
to FDA. However, almost 2 decades since passage of DSHEA, advances in technology
have provided new, safer methods of preparation for botanical and other dietary
ingredients that could not have been predicted at the time—technologies and
processes that ought not per se
trigger FDA premarket notification requirements, according to numerous comments.
“In short, [according to FDA’s
view of DSHEA], only the most basic manufacturing methods would not chemically
alter an ingredient,” stated ANH in its comments
to FDA. “The result is to deny use of innovations that leave the biochemistry
of ingredients unchanged but that involve new modalities for production.”17To illustrate, supercritical
carbon dioxide extraction is often cited as an example of a process that,
although known to be safe, would require a NDI notification. “Carbon dioxide
(CO2) is a direct food substance affirmed as Generally Recognized as Safe
(GRAS),” Sabinsa Corporation noted in its 2011 comments. “Due to the health,
environmental and safety concerns associated with the use of some organic solvents
and the possible solvent contamination of the final product, supercritical
fluid extraction, using CO2, as an extraction fluid, offers an excellent
alternative to the use of chemical solvents. Carbon dioxide leaves no reside or
causes no damages to the ingredient profile.”12 Because DSHEA was enacted as part
of an effort to ensure the accessibility and safety of a range of dietary
ingredients in dietary supplements, various experts have expressed concern that
the language in FDA’s draft NDI guidance
document is contrary to the true intent of the law. “ABC believes that the
emphasis for the matter of determining whether an NDI notification should be
made should focus on the safety (which implicates chemical profile) of the resulting
extract, not the process by which it is made nor the solvent(s) that is/are
used in the extraction process,” said Blumenthal.10 However, some argue that these
measures are specifically designed to increase product safety. At UNPA’s 2011
conference on FDA’s NDI Draft Guidance, Nancy Booth, a scientific consultant
from Spherix, said that virtually any type of processing—even water
extraction—could introduce environmental contaminants and therefore should be
regulated appropriately.18 Other industry experts insist that the Good
Manufacturing Practices (GMP) regulations, which focus on how products are manufactured and impose requirements to prevent
adulteration in processing, are the proper method to address these concerns,
and that NDI requirements should focus on the safety of the underlying
ingredient, not the manufacturing process. Regardless of the intent of DSHEA,
if FDA were to enforce the NDI provision according to its draft guidance, the
number of NDI notifications would undoubtedly increase significantly. FDA,
however, insists that clarification of this process will result in a smoother
process. “The second goal of the guidance is to enhance the quality of those
submissions, so although we will be receiving a higher volume, the increased
quality of the information will reduce the amount of follow-up necessary and
thus servicing to offset the influx,” said Dr. Fabricant.10
Synthetic Botanicals and New Ingredient CategoriesIn the years since the passage of
DSHEA, advances in technology have also allowed industry members to effectively
create synthetic versions of some ingredients, and other novel ingredients such
as bacteria (e.g., probiotics) are increasingly included in supplements.
Today, scientists are able to
create compounds in a lab that are indistinguishable from those found in
nature. Ingredient suppliers may choose to synthesize certain ingredients for
environmental, quality-control, or economic reasons, said Blumenthal. Mister of CRN urges FDA to
consider the bigger picture. “What’s particularly troubling is that this isn’t
even a question of safety. To FDA, it’s definitional—if the [botanical]
ingredient is produced in a lab, no matter how bio-identical it is—it can’t be
used in a dietary supplement, period. And no amount of safety data appears that
it will change the agency’s mind,” he said.18 FDA has not yet specifically
expounded on non-botanical [and non-vitamin] synthetic ingredients, e.g., synthetic
co-enzyme-Q10 or L-carnitine. On that basis, these synthetic ingredients can be
considered legal dietary ingredients. Further, synthetic botanical constituents
that are also GRAS or approved food additives can also be legal dietary
ingredients. Further, the focus on digestive
health in recent years has led to the marketing of many products with
beneficial bacteria, as noted by Sabinsa Corporation in its comments. “In the draft guidance section IV.C.3, FDA simply states
that ‘bacteria that have never been consumed as food are unlikely to be dietary
ingredients.’ With this statement, FDA appears to eliminate all new probiotic
strains, which have not been consumed yet as food, from consideration as
dietary ingredients.”12 According to Dr. Fabricant, when
it comes to the law as written, it is a matter of semantics. “Ingredients need
to be dietary ingredients before they can be NDIs,” he said. “Synthetic
botanicals and probiotics may not lie in the diet, and thus may better fit into
the food additive category. It’s up to product manufacturers to
prove probiotics were in the diet of man before they were isolated as an
ingredient and used in a dietary supplement or as a GRAS ingredient.”6
Next Steps Despite the impassioned reactions
from concerned parties after the publication of the draft guidance, the passage
of DSHEA is still seen as a boon to the dietary supplement industry. A July
2011 NDI article described it as “a
big win for the industry [that] set up several principles that has allowed
industry to thrive to this day, including supplements being regulated as foods
rather than drugs…. and supplements not requiring FDA preapproval.”19 However, the publication of the
draft guidance threatens that legacy according to some industry spokespeople. The
general consensus from many industry members is that the draft guidance
document is a move by FDA to increase regulation of dietary supplements and dietary
ingredients, setting up a premarket approval system that was not the intent of
Congress in enacting DSHEA. “It would appear… that the Agency is intending to
use this guidance as a means to create a non-statutory pre-market approval
system vehicle for any dietary ingredient that the Agency deems is an NDI,”
Blumenthal wrote.20 Dr. Fabricant maintains that the draft
guidance document is consistent with the language of DSHEA. “Guidance documents
are not usually enforceable rules or requirements by themselves, but serve more
to define standards and expectations and in this case it would be to more
clearly communicate the new dietary ingredient requirements under [DSHEA],” he
said.10 In addition to calling for
withdrawal and revisions to the document, steps are already being taken to
change the law. Representative Dan Burton (R-IN) introduced a new bill in 2011 designed
to ease the burden of the NDI provision. The bill, known as the “Dietary
Supplement Protection Act,” moves the ODI deadline date of October 15, 1994 to
a more recent date in early 2007, effectively grandfathering supplement
ingredients marketed before that date. The virtually untarnished safety record
of dietary supplements, according to industry supporters, supports this change.21
In addition to concerns
previously addressed, the nutrition, weight-management, and personal care
products company Herbalife recommended that FDA simplify the NDI notification
process and increase transparency by using NDI master files that can help FDA
protect intellectual property or trade secrets that may be included in an NDI
submission. The master file system would also make the notification process
easier because submitters could cite the master file as part of the
notification rather than needing to generate additional safety data on the same
ingredient.22 In order to increase the efficiency
of the NDI notification process, Herbalife proposed that FDA check for all
required components before starting the 75-day countdown. FDA could then
proceed to a review of safety data and accept or reject the notification, if
appropriate. “Once implemented, a procedure like this would offer FDA,
industry, and observers (Congress, the public, interest groups) an easy way to
know the status of any pending NDI filing and to plan product development,”
Herbalife said in its public comments on the draft guidance.22 To date, FDA has received an
estimated 149,000 pages of comments regarding the July 2011 draft guidance documents.7
Much time is needed, they say, to review all of the comments before proceeding
with an official response. The timeline for action is currently unknown. “[W]e absolutely don’t want this
to just sit around as a draft for years,” said Duffy McKay, ND, vice-president
of scientific and regulatory affairs for CRN. “That would be the worst outcome.
Some people want it to be withdrawn, others want substantial revisions. But
doing nothing would be detrimental; it would be unfair to leave the industry in
limbo.”23
—Tyler Smith References
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