The FDA's Proposed CGMPs and the Future of the Dietary Supplement Market

New Rule to Control identity, purity, quality, strength, and composition" of products.

http://www.vitaminlawyernews.com

This release 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.
 
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 like John Hammell (www.iahf.com) 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, youve 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.
 
 The FDA's Proposed Rule "...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 recent conversations Ive had with activist John Hammell and 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.
 
While no one wants to see adulterated or misbranded products in the marketplace, the FDAs 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.

 Ralph Fucetola JD
 Ralph.Fucetola@usa.net
http://www.vitaminlawyer.com