New Industry Regulations Contain Troubling Flaws
by Wyn Snow, Managing Editor
FDA has proposed a new set of good manufacturing practice (GMP)
regulations, and the comment period ends August 11. What changes
do these new GMP regulations introduce? Do they solve any of the
industry's current problems? What impact will they have on consumers?
And why should consumers care?
problems will the new GMPs solve?
central feature of the new GMPs is that companies will be required
to test both raw materials and final products for identity, purity,
quality, strength and composition. This is designed to ensure that
the contents of the bottle matches the contents of the labela
challenge that has plagued the industry for many reasons, only some
of which relate to shoddy manufacturing practices.
spoke with a variety of people to learn how these new GMPs will
impact both industry and consumersand found a mixed bag of
who represent companies on the larger end of the spectrum, many
of whom also produce drugs (both over-the-counter and prescription)
welcomed the GMPs and said their members are, for the most part,
already in compliance. (See sidebar: Comments
from industry spokespersons.) Those in smaller companies
also welcomed the GMPsbut believe the increased testing requirements
are excessive and will be burdensome to their members.
can anticipate two end results. The new GMPs will establish a long-needed
consistent "bottom line" for the quality of manufacturing processes.
However, supplement prices will rise as the cost of increased, and
sometimes unnecessary, testing is passed on to the consumer.
Conversation with Mark Blumenthal about impact on consumers.)
testing was one of two main problems that people described. The
other was unclear terminologymaking it difficult for companies
to understand what would be required of them.
people mentioned ambiguities in the language as a problem (see sidebar:
Unclear language). The document does not define the meanings
of the key terms identity, purity, quality, strength and
composition. Several noted that the term composition
does not exist in the food GMPs and was clearly imported from pharmaceutical
most differences between this new GMP and previous proposals are
due to a shift towards pharmaceutical standardseven though
the Dietary Supplement Health and Education Act of 1994 (DSHEA)
clearly states that GMPs for dietary supplements are to be based
on food GMPs. (See 4-way
comparison of GMPs for drugs, food, and the earlier and
current proposals for dietary supplements.)
falls most heavily on smaller companies
an official set of GMPs will establish a level playing field for
quality standards in the industry. For the most part, people believe
this will benefit the industry by improving both product quality
and consumer confidence.
the proposed GMPs also tend to favor the largest companies and place
a disproportionately heavy burden on the smaller ones, which is
a significant fraction of the industry. According to a survey conducted
by the Research Triangle Institute in 1999, for 1224 companies whose
size could be determined:
very small (fewer than 20 employees)
small (fewer than 500 employees or $20 million in sales)
large (500 or more employees, $20+ million in sales)
heavier impact is primarily due to higher requirements for testing
in the new GMPs. The cost of increased testing is likely to push
the smaller players out of the market and encourage consolidation.
Whether that is a good or bad thing is debatable, but the crucial
question is: Are the testing requirements necessary or excessive?
much testing is necessary?
manufacturers were allowed to accept a "certificate of analysis"
from a supplier as proof of the identity and strength of a raw material.
Now, they must not only test all raw materials themselves, but must
also retest every time the material is moved from one facility
to another, even if there is no change in ownership.
are clearly two points where knowledge of identity (what it is)
and strength (potency) is vital for the manufacturing process: the
beginning, where raw materials are receivedand the end, where
final products are shipped out the door. Testing between those points
is useful only if the manufacturing process might change either
the nature of the substance or its potency.
type of "before, during and-after" testing also makes no sense in
the context of a repackagera company that does no manufacturing
itself, instead taking in a finished product that is ready for the
consumer and placing a new label on it. Indeed, retesting might
be completely unnecessary for products known to be very stable (such
as most calcium supplements).
there lies the crux of the problem with the new GMP testing requirements:
They will be applied to every company and every dietary supplement,
regardless of the specific circumstances of the company or the nature
of the supplement. This is like Moscow setting production quotas
and prices for all manufacturing and consumer goods throughout the
Soviet Union. It's a cumbersome, inefficient and oftentimes ineffective
procedure that doesn't take exceptions or special circumstances
will pay cost of excessive testing
redundant testing is always necessary to ensure consistent product
quality, then additional cost and higher market price is understandable-
but instead, the cost of all that testing, some of which is quite
unnecessary, will be passed on to the consumer
as higher prices.
GMPs biased against industry
more troubling than various specific flawswhich presumably
can and will be fixed by comments and suggestions from industryis
the overall tone and attitude of the proposed GMPs. The initial
487 pages of this 547-page document are a long preamble that characterizes
the entire industry as following the worst practices of its sleaziest
Michael McGuffin, president of the American Herbal Products Association,
and Roy Upton, executive director of the American Herbal Pharmacopoeia,
accuse the FDA of lying. A sentence near the beginning of the new
GMP preamble says, "Now for the first time, contaminated dietary
supplements will not be allowed to be sold."
responds by saying, "But that's an outright lie. It is already illegal
to sell contaminated dietary supplements." And Upton says, "Dietary
supplements have always been required to be authentic and pure.
So it's a complete lie." (See
McGuffin's full critique of preamble.)
the FDA's new proposed GMP regulation is likely to strengthen the
quality and consistency of products in the industry, it does have
several important flaws:
terms identity, purity, quality, strength and composition
are not defined in any way, and thus the requirements that companies
must meet are not clear.
Testing requirements are excessive and inflexible. They do not
focus on the specific testing needs of various supplements and
ingredients, nor do they take adequate account of where a company
and its procedures fit within the overall flow from raw material
to retail shelves.
is no requirement for environmental control during shipping
(see sidebar: Environmental
controls can reduce need for redundant testing).
is no requirement for expiration dates.
introductory/preamble/prologue section contains much irrelevant
misinformation based on erroneous assumptions.
recommends that you contact the FDA with your concerns.
submit your comments on these proposed GMP regulations, click on
the following link:
to docket number: 1996N-0417. (To find this regulation easily, we
recommend that you sort the pages by Docket-ID number.)
if that process does not work, email your comments to firstname.lastname@example.org.
Be sure to cite docket number 1996N-0417.
Blumenthal, executive director, American Botanical Council (ABC).
Personal communication. 19 March 2003.
Bolar. GMP Comparison Chart: Side by side comparison of new GMP
proposal, the 1997 proposal, food GMPs and drug GMPs. Regulatory
affairs committee, Council for Responsible Nutrition, 2003. www.crnusa.org/pdfs/GMP4way.pdf.
Cates et al. Survey of Manufacturing Practices in the Dietary Supplement
Industry. Center for Economics Research, Research Triangle Institute,
17 May 2000. www.foodriskclearinghouse.umd.edu/Doc/Dietary_Supplement_Survey.pdf.
Cox, Consumer Healthcare Products Association (CHPA).
Personal communication, 19 March 2003.
McGuffin, president, American Herbal Products Association (AHPA).
Personal communication. 20 June 2003.
Monheit. "Editorial: GMP's-A Framework for Industry or Just an Answer
to the FDA?" NPI Center website, 9 May 2003. www.npicenter.com/index.asp?action=NBViewDoc&DocumentID=4367.
Pompliano, NSF International (NSF),
Ann Arbor MI. Personal communication, 17 March 2003.
States Pharmacopeia. "USP Welcomes FDA Proposed Rules for Good Manufacturing
Practices Rules to Help Assure Consumers Taking Dietary Supplements."
Press release 3 April 2003. www.npicenter.com/index.asp?action=NBViewDoc&DocumentID=4192.
Upton, executive director of the American Herbal Pharmacopoeia (AHP).
Personal communication, 17 March 2003.