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Ralph Fucetola JD

Current Good Manufacturing/Marketing Practices

The Vitamin Lawyer Occasional Papers - 2003-01
cGMPs and the Future of the Dietary Supplement Market

2007 update: http://tinyurl.com/2eu6yj
Updated Blog:


Proposed Rule
2003 Update
2006 Update
2007 Update


This paper reports on an FDA “Town Meeting” The Vitamin Lawyer attended on May 9, 2003, with background and prognosis.  The new regulations will impact small firms the most.

This Report is part of a series of occasional papers prepared for The Vitamin Lawyer’s retained client base.  This particular paper is also being provided to other clients and to companies in the industry.  To retain the services of The Vitamin Lawyer, please go to www.vitaminlawyer.com and click on the Services link.

Prior to 1994 dietary supplements were in a kind of regulatory limbo.  People in the industry were never sure when or where the next federal raid would occur.  Due to the heroic efforts of health freedom activists the Dietary Supplement Health and Education Act of 1994 (DSHEA) was adopted by Congress, allowing certain types of claims to be made for Dietary Supplements.  As Vitamin Lawyer clients, you’ve heard me describe the different categories of claims.  Sometimes it seems that my main job is educating marketing people in what they can and cannot say!  Those categories are, General Wellness Claims (allowed without FDA approval), Structure & Function Claims (allowed, but with 30 day post market notice to FDA), Health Claims (allowed only after a formal petition is approved by the FDA) and Disease Treatment Claims, never allowed for Dietary Supplements.

Among the other provisions of DSHEA was a clause that would allow the FDA to establish current good manufacturing practices (CGMPs) for the industry.  The specific clause provides, at 21 USC 342(g): 

“The Secretary may by regulation prescribe good manufacturing practices for dietary supplements.  Such regulations shall be modeled after current good manufacturing practice regulations for food and may not impose standards for which there is no current and generally available analytical methodology.  No standard of current good manufacturing practice may be imposed unless such standard is included in a regulation promulgated after notice and opportunity for comment…”

Now, nearly a decade after the law was adopted, the FDA is proposing CGMPs for Dietary Supplements.  On March 7, 2003 FDA announced:

“The Food and Drug Administration today took action to help consumers get accurately labeled and unadulterated dietary supplements by proposing a new regulation to require current good manufacturing practices (CGMPs) in their manufacturing, packing, and holding. The proposed rule would, for the first time, establish standards to ensure that dietary supplements and dietary ingredients are not adulterated with contaminants or impurities, and are labeled to accurately to reflect the active ingredients and other ingredients in the product.

This proposed rule includes requirements for designing and constructing physical plants, establishing quality control procedures, and testing manufactured dietary ingredients and dietary supplements. It also includes proposed requirements for maintaining records and for handling consumer complaints related to CGMPs.

"Americans must have confidence that the dietary supplements they purchase are not contaminated and that they contain the dietary ingredients and the amounts claimed on the labels," said HHS Secretary Tommy G. Thompson. "Millions of Americans use dietary supplements, and we owe it to them to ensure that they are getting the products [for which] they're paying..."

In recent years, analyses of dietary supplements by a private sector laboratory suggest that a substantial number of dietary supplement products analyzed may not contain the amounts of dietary ingredients that would be expected to be found based on their product labels….”

The Vitamin Lawyer comments – this unnamed “laboratory” could not have tested enough of the thousands of products available for such a sweeping allegation.  This allegation must be seen in light of the extraordinary events transpiring in Australia over the past month, where the main contract alternative remedy and dietary supplement manufacturer, Pan (in business since 1901) was caught substituting ingredients, not properly cleaning mixers, and failing to control ingredient ratios.  It lost its certification.  As a result, over 1,300 products have been recalled and many small purveyors are on the brink of bankruptcy.  This is being touted by the regulators as “proof” that CGMPs must be established and enforced.  They forget to mention that Australia already has a rigid control system and that certain investigative reporters have shown that it was the failure of the regulators that led to the debacle.


Proposed cGMPs

 The FDA's Proposed Rule would –

“…would establish new standards or "current good manufacturing practices" (CGMPs) to help reduce risks associated with adulterated or misbranded dietary supplement products.

“The proposed rule would establish industry-wide standards necessary to ensure that dietary supplements are manufactured consistently as to identity, purity, quality, strength, and composition.

“The minimum standards include requirements on the design and construction of physical plants that facilitate maintenance, cleaning, and proper manufacturing operations, for quality control procedures, for testing final product or incoming and inprocess materials, for handling consumer complaints, and for maintaining records.

“Examples of product quality problems the CGMPs will help prevent are: superpotent, subpotent, wrong ingredient, drug contaminant, other contaminant (e.g., bacteria, pesticide, glass, lead), color variation, tablet size or size variation, under-filled containers, foreign material in a dietary supplement container, improper packaging, and mislabeling.

“The proposed CGMPs would apply to all firms that manufacture, package, or hold dietary ingredients or dietary supplements, including those involved with the activities of testing, quality control, packaging and labeling, and distributing them. The proposed regulations also would apply to both domestic firms and foreign firms that manufacture, package, or hold dietary ingredients and dietary supplements for distribution into the U.S.  [Comment from The Vitamin Lawyer:  please note that the rules will also apply to firms that “…hold… dietary supplements… [including] distributing them…”  This is not just a problem for the contract manufacturers, but is a major change that will impact every distributor with its own labels.  Especially note that distributors will be responsible for keeping records of Adverse Reactions that may be due to failures to abide by CGMPs.]

“FDA is soliciting comments from the public and industry on this proposal. Written comments will be received until [June 6, 2003]…”

Further, FDA stated,

"This proposed rule would establish the standards necessary to ensure that dietary supplements and dietary ingredients are not adulterated with contaminants or impurities and are labeled to accurately reflect the active ingredients and other ingredients in the product.

“Specifically this proposal would:

 - Require the use of new industry-wide standards in the manufacturing, packing, and holding of dietary supplements, thus reducing risks associated with dietary supplements that are contaminated with harmful or undesirable substances such as pesticides, heavy metals, or other impurities or are not properly labeled to accurately describe what they contain.

 - Ensure that the identity, purity, quality, strength, and composition of dietary supplements are accurately reflected on the product label, which would be a significant step in assuring consumers they are purchasing the type and amount of ingredients declared.”

It was clear from the Town Meeting of May 9, 2003 that the FDA is very aware of the potential impact on small vitamin businesses.  The main problem is that they are not realistically considering the economic impact on small business, as the law requires of them.  First, while admitting that the vast majority of the firms are very small, most with less than 20 employees, they have defined “small” as companies with less than 500 employees.  There are only a handful of companies with more than 500 employees in the business.  The only concession to “small” firms is a three year phase in of the regulations.  That means a company with 400 plus employees and up to $50 million is sales would have the same record keeping and other requirements as a truly small firm -- clearly a rule that may drive small companies out of business.

From a recent conversation I’ve had with  research scientist Durk Pearson, it is certain that leading nutrient lawyer Jonathan Emord will be bringing a lawsuit on behalf of Durk Pearson and his partner Sandy Shaw to overthrow the final regulations.  Pearson and Shaw have won a number of significant court victories in recent years (including the landmark Health Claims case of Pearson v Shalala and had a hand in the Supreme Court leading Commercial Speech case of Thompson v Western States Medical Centers – see The Vitamin Lawyer News for details, www.vitaminlawyernews.com).

It appeared to this observer that the Town Meeting had been devised to “prove” that the FDA was living up to its obligation to consider the impact on small business.  One of the four FDA speakers, Peter Vardon of the Office of Scientific Analysis and Research (OSAR) was there specifically to provide an economic analysis.  He admitted that there was a large degree of uncertainty in the analysis.  Some of the points he raised:

- The largest costs to firms will be (1) record keeping and (2) product testing.

- The estimated costs during the three-year phase-in will be $38,000 to $47,000 per year per firm.  This will impact small as well as large firms.

- The median firm has 8 employees and less than $500,000 in income.  Between 250 and 300 of such firms may go out of business as a result of the regulations.

Additional impacts of the regulations that will effect small businesses include:

Adverse reaction record keeping and reporting will be a major element in this new system.  While we were told that “serious adverse events” should be reported through MedWatch, the regulations will require records to be kept of any AEs related to CGMPs.  This will include follow-up investigations by the distributor and records of the resolution of any complaints.

If you have your own labeled product, that product must be tested “at least once” to assure the “identity, purity, quality, strength, and composition” of the product.

Manufacturers are required to follow CGMPs and to maintain three types of records, (1) batch records (while the regulations may not require Lot Numbers on each label, such a practice could limit the scope of recalls], (2) Calibration Records [but not “process and equipment validation”] and (3) Consumer Complaints.  There are hygienic requirements for facilities and employees.

Distributors with their own labels are responsible to insure that the products are not misbranded – that is, they have the declared amounts and that there is not claim without prior substantiation.

All companies must have designated quality control personnel (can be a part-time position) and must investigate all adverse events related to CGMPs.

While the FDA, at the Town Meeting, sought to position the new regulations as “like” the Part 110 Umbrella Food GMPs, in my opinion, the proposed CGPMs are not, as required by statute, “modeled after current good manufacturing practice regulations for food…”  Further, the FDA has failed to adequately address the small business impact.

As part of my retainer services, The Vitamin Lawyer will be providing Comments to the FDA along these lines on behalf of very small firms, in conjunction with the extensive Comments that Counsel Emord will submit (with Durk Pearson’s permission, we will be “joining in” those Comments, since the rules of Court limit future litigation to issues raised in the Comment process).

While no one wants to see adulterated or misbranded products in the marketplace, the FDA’s proposals put too great a burden on truly small firms.  Rather, the full burden of regulation should fall on the pharma-type large firms, with the standard Umbrella Food GMPs providing guidance to the small firms.

In either event, the Nutrient Marketplace continues to evolve in response to market forces and government intervention.  The Vitamin Lawyer will keep you informed as matters develop.


2003 Update
08/18/03 rev. 12/12/03

 If you make or market dietary supplements, you need to be ready for the coming changes in the vitamin regulatory situation.  A couple of news notes that give you the flavor of what is happening, and then, below, some suggestions about what you can do.


 September 3, 2003 - The FDA has announced the formation of a special inspection team, changes in its pre-approval inspection program, and the release of four draft guidance documents and a final guidance on various manufacturing issues as part of a continuing effort to improve current good manufacturing practices (cGMPs).

The agency hopes these steps will help make pharmaceutical manufacturing "more efficient and safer," FDA Commissioner Mark McClellan said. The guidances are intended to help the pharma industry and the agency "focus their efforts where they are most beneficial, on critical and risky areas," he said Wednesday.  The five guidances, published in today's Federal Register, were:

  1. A draft guidance establishing a dispute resolution process for science and technical issues related to cGMPs;
  2. A draft guidance setting guidelines for using comparability protocols to implement changes in manufacturing processes after obtaining marketing approval for protein-based human and veterinary drugs and biological products;
  3. A draft guidance establishing a regulatory framework to encourage voluntary implementation of new manufacturing and quality assurance technologies;
  4. A draft guidance updating recommendations on aseptic processing for sterile drug products; and
  5. A final guidance outlining the FDA's enforcement of 21 CFR Part 11, dealing with electronic records and signatures.

The guidances and other actions are part of a two-year agency initiative, "Pharmaceutical cGMPs for the 21st Century: A Risk-Based Approach."

STED Program - MORE "Harmonization" on the way - 09/15/03
Summary Technical Documentation for Demonstrating Conformity to the
Essential Principles of Safety and Performance of Medical Devices"

Says FDA - "The Center for Devices and Radiological Health (CDRH), U.S. Food and Drug Administration (FDA) is pleased to announce a pilot program to assess the feasibility of using an internationally harmonized format in review of submissions for device safety and performance *** for the benefits that will accrue to the medical device community." - http://www.fda.gov/cdrh/International/sted.html

The Vitamin Lawyer cGMPs Services


1. All Vitamin Label Owners MUST file the required Claim Notice
FDA Structure and Function Claims Notice Requirements

2. Of course your web site also needs a Site Use,
Privacy, Disclosure, Disclaimer Statement!

3.  Contact the me for my Interim cGMP Policy Statement
(for me to adapt to your company)
for your company to legally adopt, as you prepare for
implementation of the new regulations -
email ralph.fucetola@usa.net and put cGMP
in the subject line
{fees for this service start at the single hour level}.

See: http://tinyurl.com/2eu6yj
For Outlines of Formats

4. The Vitamin Lawyer is here to help... cGMP Consultations,
Checklists, Risk Assessment Policies, QC Procedures...

 What happens when the  FDA visits your company?
 FDA Inspection Concerns

 The Right of the Public to the Truth
 The Standard of Substantiation


2006 Update

Information on the 2006 Adverse Event Reporting law:

2007 Update

May: OMB Approves cGMPs
June: cGMPs Issued; effective August 2007

 Ralph Fucetola JD                                                                                            ralph.Fucetola@usa.net

© 2003, 2006, 2007 [08/15/07]



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