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Headline News

FDA's New Industry Regulations Contain Troubling Flaws
by Wyn Snow, Managing Editor

The 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?

What problems will the new GMPs solve?

The 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 label—a challenge that has plagued the industry for many reasons, only some of which relate to shoddy manufacturing practices.

SupplementQuality.com spoke with a variety of people to learn how these new GMPs will impact both industry and consumers—and found a mixed bag of reactions.

Those 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 GMPs—but believe the increased testing requirements are excessive and will be burdensome to their members.

Impact on consumers

Consumers 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.

(See also sidebar: Conversation with Mark Blumenthal about impact on consumers.)

Excessive testing was one of two main problems that people described. The other was unclear terminology—making it difficult for companies to understand what would be required of them.

Ambiguous language

Many 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 regulations.

Indeed, most differences between this new GMP and previous proposals are due to a shift towards pharmaceutical standards—even 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.)

Impact falls most heavily on smaller companies

Having 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.

However, 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:

53% were very small (fewer than 20 employees)
36% were small (fewer than 500 employees or $20 million in sales)
11% were large (500 or more employees, $20+ million in sales)

This 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?

How much testing is necessary?

Previously, 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.

There 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 received—and 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.

This type of "before, during and-after" testing also makes no sense in the context of a repackager—a 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).

And 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 into account.

Consumer will pay cost of excessive testing

If 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.

New GMPs biased against industry

Far more troubling than various specific flaws—which presumably can and will be fixed by comments and suggestions from industry—is 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 members.

Both 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."

McGuffin 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.)

In conclusion

While 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:

  • The 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.

  • There is no requirement for environmental control during shipping (see sidebar: Environmental controls can reduce need for redundant testing).

  • There is no requirement for expiration dates.

  • The introductory/preamble/prologue section contains much irrelevant misinformation based on erroneous assumptions.

SupplementQuality.com recommends that you contact the FDA with your concerns.

To submit your comments on these proposed GMP regulations, click on the following link:
www.accessdata.fda.gov/scripts/oc/dockets/commentdocket.cfm
Refer to docket number: 1996N-0417. (To find this regulation easily, we recommend that you sort the pages by Docket-ID number.)

Or if that process does not work, email your comments to fdadockets@oc.fda.gov. Be sure to cite docket number 1996N-0417.

Sources

Mark Blumenthal, executive director, American Botanical Council (ABC). Personal communication. 19 March 2003.

Paul 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.

Sheryl 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.

Virginia Cox, Consumer Healthcare Products Association (CHPA). Personal communication, 19 March 2003.

Michael McGuffin, president, American Herbal Products Association (AHPA). Personal communication. 20 June 2003.

Len 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.

Kathleen Pompliano, NSF International (NSF), Ann Arbor MI. Personal communication, 17 March 2003.

United 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.

Roy Upton, executive director of the American Herbal Pharmacopoeia (AHP). Personal communication, 17 March 2003.end-of-story

 

   
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