Friday, August 31, 2007

08/31/07 - More on cGMPs impact


1. Health Freedom Blog Update
2. More on the GMPs

1. Vitamin Lawyer Health Freedom Blog New Posting

More News on Lobbying Congress to Divest FDA of Food Authority.

2. More on GMPs

I’ve been reading the GMPs that were issued in June. You can read my initial blog on them at: .

Meanwhile, a number of organizations have also been reviewing the new Rules and I’ve been reviewing what they are saying. AHPA (American herbal Products Association) has been part of the process from the start. Here are excerpts from a report they’ve prepared (my headings in ALL CAPS).

BACKGROUND: "…compared to the existing cGMP for conventional foods, which is expressed … in just under six thousand words, the final rule on dietary supplement cGMP will be codified in 21 CFR 111 in over sixteen thousand words."

"Publication of this final rule is the culmination of a process that was begun in 1995 with the submission to FDA of an “industry draft” by AHPA, CRN, NDMA (now CHPA), NNFA (now NPA), and UNPA. This draft was published as an advance notice of proposed rulemaking on February 6, 1997, and followed by publication of a proposed rule on March 13, 2003" The final rule was published June 22, 2007 and can be seen at:

APPLIES TO: “The rule applies to all firms that manufacture, package, label or hold dietary supplements for sale in the U.S. and Puerto Rico, with the exception of retailers who hold dietary supplements “for the sole purpose of direct retail sale to individual consumers.” The final rule notes, however, that this retailer exception does not extend to “a warehouse or other storage facility for a retailer,” or to “a warehouse or other storage facility that sells directly to individual consumers.”

STRUCTURE OF RULE: The Rule is divided into 16 parts:

“Subpart A General Provisions (*)
Subpart B Personnel
Subpart C Physical Plant and Grounds (* as Buildings and Facilities)
Subpart D Equipment and Utensils (* as Equipment)
Subpart E Requirement to Establish a Production and Process Control System (*as Production and Process Controls)
Subpart F Production and Process Control System – Requirements for Quality Control
Subpart G Production and Process Control System **
Subpart H Production and Process Control System – Requirements for the Master Manufacturing Record
Subpart I Production and Process Control System – Requirements for the Batch Production Record
Subpart J Production and Process Control System – Requirements for Laboratory Operations
Subpart K Production and Process Control System – Requirements for Manufacturing Operations
Subpart L Production and Process Control System – Requirements for Packaging and Labeling Operations
Subpart M Holding and Distributing
Subpart N Returned Dietary Supplements
Subpart O Product Complaints
Subpart P Records and Recordkeeping”

* From the Food GMPs
** “Requirements for Components, Packaging, and Labels and for Product That You Receive for Packaging or Labeling as a Dietary Supplement”

APPLIES TO SOME CAM PRACTITIONERS: "FDA also noted in the preamble to the final rule that it “would be appropriate to consider the exercise of our enforcement discretion, on a case-by-case basis, to determine whether to apply the requirements of this final rule” to health care practitioners, such as acupuncturists, herbalists, and naturopaths who are “adequately trained in their profession” and who provide supplements that they prepare in “one-on-one consultation[s].” The agency stated, however, that it is “not considering exercising our enforcement discretion with respect to practitioners who prepare batches of herbs and sell them to individual consumers without determining whether the dietary supplement is appropriate for each consumer’s needs in a one-on-one personal consultation, or those that prepare batches of a dietary supplement for which there is a known or suspected safety concern.”"

Since that’s written in bureaucratic “bass-ackwards” let’s make that clearer: IF you do individualized one-on-one counseling, the FDA does NOT expect you to meet GMPs; if you repackage ingredients without one-on-one consultations, you will be treated as a distributor and be required to meet GMPs.

I’ve also read the United Natural Products Alliance report on the GMPs. In general their analysis is similar to AHPA. Some points they note (quotes are from the FDA Rule comments):

PRODUCT COMPLAINTS: “The final rule defines product complaint…examples of product complaints are foul odor, off-taste, illness or injury, disintegration time, color variation, tablet size or size variation, under-filled container, foreign material in a DS container, improper packaging, mislabeling or DS that are super potent, sub-potent or contain the wrong ingredient or contain a drug or other contaminant (e.g., bacteria, pesticide, mycotoxin, glass, lead)…”

QUALITY: “Quality means that the dietary supplement consistently meets the established specifications for identity, purity, strength and composition and limits on contaminates and has been manufactured, packaged, labeled and held under conditions to prevent adulteration…”

GMP TRAINING: While FDA will not provide GMP training materials, “…paragraph, § 111.14(b)(2) requires you to make and keep documentation of training, including the date of training, the type of training and the persons trained.”

BATCH TESTING: “We are persuaded that as an alternative to testing each finished batch of product, we can allow for the use of a statistically sound sampling and testing program for finished batches of DS unless a manufacturer chooses to test every batch. Such a sampling and testing program is feasible when controls are implemented earlier than the final product stage in the manufacturing process. Controls include the use of a C of A from a qualified supplier for specifications other than the identity of a DI and the establishment and monitoring of in-process manufacturing controls.”

“We agree with the comments that if we reduce the requirements for testing at the finished batch stage, then it is critical that you determine whether components meet specifications. We address this issue in the following two ways: (1) Each manufacturer must confirm the identity of each component prior to use (you must test or examine DIs to verify the identity but may rely on a C of A to confirm the identity of components other than DS) and (2) Each company must confirm other required specifications for components prior to use, either by relying upon a C of A or by testing or examining the components.”

“Because of the critical importance of insuring the proper identity of DIs – they are the central defining ingredient of a DS – we are requiring each firm that uses a DI to perform its own testing or examination for identity of each DI prior to use. Firms may not rely upon a C of A provided by suppliers to determine the identity of a DI before use. … We believe that the minimum criteria that we are establishing for a C of A, together with the requirement that a firm relying on a C of A must qualify a supplier and periodically repeat that qualification process can prevent the problems that have occurred with faulty certificates in the past.”

“Under final § 111.75(a), a firm may rely upon a C of A from its supplier of a component provided that certain criteria are met which include the following: (1) The firm first qualifies the supplier by establishing the reliability of the supplier’s C of A through confirmation of the results of the supplier’s tests or examinations; (2) The C of A includes a description of the tests or examination method(s) used, limits of the tests or examinations, and actual results of the tests or examinations; (3) The firm maintains documentation of how it qualified the supplier; (4) The firm periodically reconfirms the supplier’s C of A; (5) The firm’s quality control personnel review and approve the documentation setting for the basis for qualification (and re-qualification) of any supplier.”

PRODUCT SPECIFICATIONS: “The requirement to establish specifications is not limited to when a manufacturer purports that its product possesses attributes of strength and composition on the label. One comment asks for guidance as to what constitutes an official or scientifically valid standard for specifications. We are not aware of any officially recognized standard for specifications… the manufacturer establishes the set of criteria to which a product should conform to be considered acceptable for its intended use. In general, a specification may include a list of tests, references to analytical procedures, and appropriate acceptance criteria that are numerical limits, ranges or other criteria for the tests described.”

COMPLIANCE NOTIFICATION: “…an unqualified statement such as ‘produced in compliance with dietary supplement current good manufacturing requirements,’ without more, could suggest the product may be safe and effective or somehow superior to other DS products that are subject to the same CGMP requirements (id.) [and] would likely be considered misleading …, but that including language clarifying to consumers that all DS must be manufactured in compliance with CGMP requirements, and that such compliance does not mean that the DS is safe or effective, may be a way to cure that unqualified statement … Thus, we are not prohibiting voluntary statements on the DS label, provided that such statements are truthful and non-misleading…”

GMP & AER: And, despite the new AER law, “We continue to strongly recommend that firms that receive product complaints, that are not ‘serious adverse events’ notify us about any illness or injury, because, for example, we may have additional expertise or data that may be helpful in investigating the complaint or determining whether the problem applies to more than one product…We encourage you to include our recommendations in the written procedures that you develop for handling product complaints.”

CONCLUSION: Your bottom line: over the next three years, as GMPs become effective first for large firms, then in 2 years for medium firms (under 500 employees) and finally in three years for small (under 20 employees) individual firms will have to manage their compliance with the requirements. The Vitamin Lawyer Consultancy will be available to help.

STANDARD SOP: Expect my revised Standard Operating Procedures (for Dietary Supplement companies and for CAM practitioners) providing for phasing in the GMP requirements, to be available in the next month or so. I’ll let you know as soon as they are ready. You can see outlines of my pre-final rule SOPs at - these will be re-organized to fit the 16 GMP categories noted above. I estimate it will take 2 – 3 hours to customize the revised formats for each operating company responsible for GMPs.

Friday, August 17, 2007

08/17/07 - Web Site Mistakes - Speaking in NJ 09/19


1. Health Freedom Blog Update
2. Web Site Mistakes
3. Wiki Biased Editing Exposed
4. I’ll be speaking in NJ on September 19th

1. Vitamin Lawyer Health Freedom Blog New Posting

New link established to allow Health Claims comments to FDA! Comments end: 08/31/08.

2. Entireweb Newsletter * August 14, 2007 * ISSUE #361 *

Excerpts from: Do You Make These Mistakes With Your Web Site?

“… no web site is absolutely perfect… But there are some basic web site mistakes …
- Not enough content. - …minimal information along with their contact information on their web sites … today's web visitors are looking for … lots of good quality content … build credibility for your business.
- Old or outdated content. - If you want visitors and search engines to pay attention to your web site, you need to keep adding new content and updating the existing information....
- Not being search engine friendly. - … in order to be included in the search engine databases.
- Not monitoring your site in the search engines. - … Monitoring your web site means that you can react to changes and take appropriate steps to make sure your site shows up in the search results and that web traffic keeps flowing.
- The site is built using Frames or Flash. - Not too many web sites still make this mistake…
Making your web site the best it can be is a very effective and affordable marketing option for most small businesses. Of all the other types of advertising and marketing that you do each year, your web site has the potential to be seen by more customers, can continue to promote your company perpetually through links, is always accessible to customers, and can instantly reflect changes and provide fresh information to draw people in….”
About the Author: Lauren Hobson is the Editor of Biz Talk Newsletter and the Five Sparrows Marketing Blog from Five Sparrows, LLC at

3. Wiki Biased Editing Exposed

Has your company been the victim of derogatory Wikipedia postings?

Says “The credibility of the online encyclopedia Wikipedia has taken another dive after a newly developed software program exposed how the CIA, corporations like Diebold and others routinely edit entries to bury criticism and manipulate the truth . . . Now a CalTech graduate student has developed a software tool that threatens to slam the final nail in the coffin of any credibility Wikipedia had left… Wikipedia Scanner -- the brainchild of CalTech computation and neural-systems graduate student Virgil Griffith -- offers users a searchable database that ties millions of anonymous Wikipedia edits to organizations where those edits apparently originated, by cross-referencing the edits with data on who owns the associated block of internet IP addresses," reports Wired News.”

"The Wikipedia Scanner ( also allows users to type in an IP range and find out which organizations are editing what pages on Wikipedia."

Adds PrisonPlanet: "Though Wikipedia's raison d'etre is obviously based around allowing users to edit the content, the checks to prevent abuse and organized partisan attack campaigns against certain subjects or ideas are non-existent and the absence of any kind of reasonable moderation is destroying Wiki's reputation. ... Wikipedia is fast becoming a complete anathema to reliable research and will see its wavering reputation as a trustworthy source for information quickly evaporate if it continues to allow itself to be abused by intelligence agencies, corporations and dedicated trolls."

Over the past two years we've noted that attempts to put positive postings on Wikipedia about alternative healthcare and natural nutrients has been met with attacks by "Quackwatch" types, even as the "official" Quackwatch sites and founders have been found by courts to be untrustworthy of belief. Will see over the next few months if Wikipedia is capable of reforming itself to regain its credibility.

4. I’ll be speaking in NJ on September 19th - Here’s the flyer from NJNHP:

New Jersey Natural Health Professionals & Natural Solutions Foundation
Health Freedom vs. Health Tyranny: Your Voice Matters

September 19, 2007 7:00 p.m. - 10:00 p.m.
VFW Post 7925 - 45 Plymouth Road - Fairfield, New Jersey

Guest Speakers:
Rima E. Laibow, MD
Founder Natural Solutions Foundation
Maj. Gen. Albert N. Stubblebine III (US Army Ret.)
President Natural Solutions Foundation
Ralph Fucetola, JD
Best known as “The Vitamin Lawyer”
Professor Murray Sabrin
Spokesperson for Presidential Candidate & U.S.Congressman Ron Paul

For more information/reservations, please contact:
Sharan Woods, President
New Jersey Natural Health Professionals
Fairfield, New Jersey

Saturday, August 11, 2007

08/11/07 - Superfooods Market to Double by 2011


1. Health Freedom Blog Updates
2. Superfoods market to double by 2011

1. Vitamin Lawyer Health Freedom Blog New Postings

AER Regulations Immanent… EU Backs off banning natural vitamins!!

2. Superfoods market set to double by 2011 - Alex McNally

“Aug. 10, 2007 - The superfood and drink market is expected to almost double in the ten year period up to 2011, says a report published today, with soy products and exotic fruits leading the charge.

…Michael Hughes, market analyst and author of the report Super Food and Drinks: Consumer Attitudes To Nutrient Rich Products, said shoppers are actively seeking nutrient rich fresh, organic and functional food and drinks and turning their backs on foods high in fats, sugars and salts… Hughes said: "The trend towards 'positive nutrition' is well reflected by the recent popularization of superfoods, especially in the UK and US."

As a result, superfoods and drinks, like acai and goji berries, are seeing a surge in demand. Datamonitor defined superfoods for the purpose of the report as foods rich in "specific nutrients and phyto-chemicals (i.e. anti-oxidants) and are promoted as being able to improve health condition and/or disease prevention." A spokesperson told that the definition includes both foods which are naturally high in nutritional value and those with added nutrition. This means it can include much of the functional food market. Many food and drinks associated with superfood status have also enjoyed healthy growth in the last five years and this - in part - can be attributed to this status, he added. Hughes said: "The popularization of superfoods means that many food and drinks now have a 'healthy-halo' which significantly influences consumer preferences."

Exotic, highly fashionable fruits such as acai berries, goji berries and pomegranates have all risen in popularity, with pomegranate currently one of the most fashionable superfood ingredients, the analyst said. In the period January 2005 to May 2007, there had already been a 500 per cent increase in the number of products using pomegranate as an ingredient compared to the period 1999 to 2004.

Hughes added: "Right now, pomegranate is the hot ingredient, but this is likely to be superseded given that new ingredients are being continuously touted. "Monitoring these developments will be vital if industry players are going to fully capitalize on the superfoods movement." … Green tea sales have grown substantially in the US. The market grew from €18m ($119m) in 2001 to €116m ($160m) in 2006… Datamonitor also identified an opportunity for manufacturers to respond to growing time constraints which are leading to people in Europe missing around 100 meals a years because they do not have time. The report suggests companies can take advantage of this by offering nutritionally enhanced snacks as a substitution for missed meals.

Friday, August 3, 2007

08/03/07 - AER Regulations about to be issued.


1. Health Freedom Blog Update
2. AER Regulations Immanent
1. Vitamin Lawyer Health Freedom Blog New Posting
FDA enabling act delayed! Hope abounds…

2. AER Regulations Immanent

This late breaking news from NutraIngredients. Please note this indicates that FDA is about to issue the Adverse Event Reporting regulations mandated by the law President Bush signed last December. The law is supposed to go into effect 12/22/07. These guidelines would be the 4th major guideline about Dietary Supplements issued by FDA over the past half year or so.... an unprecedented level of regulation enhancement.

CRN urges FDA interpret adverse events bill with caution - By Clarisse Douaud

08/03/2007 - The Council for Responsible Nutrition (CRN) has expressed its concern to the US Food & Drug Administration (FDA) over alleged labeling requirements the agency may include in its upcoming adverse events reporting guidance ... The points in question pertain to a requirement for labels to include a full street address as well as introductory language informing customers how … [report adverse events] … ‘To issue guidance that would require de facto label changes would cause a great deal of confusion…’ wrote [CRN] in the July 31 letter addressed to … FDA's Center for Food Safety and Applied Nutrition… Known as the AER bill, the amendment to the Food, Drug and Cosmetic Act was passed in December 2007 and will oblige supplement manufacturers, packers and distributors to notify FDA of any serious adverse adverse events reports (AERs). The bill is applauded by industry associations for its potential as an extra post-market precautionary measure to secure more credibility for supplement makers… now anticipating the imminent release of FDA's guidance on "the minimum data elements that should be included in a serious adverse event report". The document will essentially outline how the bill is to be interpreted … The so-called introductory language would instruct consumers how to use the contact information. For … example…: "To report an adverse event, contact..." and "If you experience problems with this product, contact…"