Monday, May 21, 2018
Thursday, May 3, 2018
WHAT WE CAN LEARN
What Companies Can Learn From the Riddhi Vitamins' Cease and Desist Order*
FROM FDA COURT ORDER
Riddhi USA is a wholesale dietary supplement manufacturing company. It manufactures products for label-owning marketing companies, like many of the Companies that receive the Vitamin Consultancy Newsletter.
After an inspection the violations were considered so egregious that a Federal Judge was asked to order Riddhi to stop all activities until it could meet GMP requirements. Needless to say, all of its customers, Companies like yours, are scrambling to find new manufacturers.
What are the lessons we need to take from this regulatory action?
Let's start by listing what FDA thought were the most serious violations:
"- failing to establish product specificationsThese are nearly all Standard Operating Procedures violations.
-- for the identity, purity, strength and composition of the finished dietary supplements
- inadequate master manufacturing and batch production records
- lack of quality control procedures
- lack of procedures to investigate product complaints
- products’ labeling failed to declare dietary ingredients, allergens and place of business."
Either Riddhi did not have the written procedures or failed to implement them. That also means the customers of Riddhi failed to "be in a state of control" -- the requirement that applies to all label-owners.
Specifications. Records. Procedures...
You need to have them. You need to implement them. FDA publicized the Riddhi case as a warning to all companies that the agency can shut you down if you fail to adopt SOPs, train employees in their use, and actually implement them.
The Vitamin Consultancy provides up-to-day procedures and the OPS 4 SOPs system that enables you to implement the specifications, records and procedures required.
It is up to the Company's senior management to take the lead in careful implementation.
The SOP introduction indicates:
"The following Positions in the Company are listed in these SOPs: the CEO, COO, Quality Control Manager (QCM), Emergency Manager (EM), SOP & CCDS Manager, Customer Service Manager and Warehouse Manager. The COO or (where one is not designated) the CEO shall hold these Manager Positions unless the Positions are filled by appointment by the CEO..."
CEO/COOThe Vitamin Consultancy offers "refresher" training sessions where staff members assigned to the different positions mentioned in the SOPs can recommit to following the SOP procedures.
Customer Service Manager
More information here: http://vitaminconsultancycertification.weebly.com/ops-4-sops.html
Practice Note: Reading the FDA Regulation changing the way conventional food labels are configured. The new Regulation is being delayed until 2020 (good news!).
Yes, I was reading down the hundreds of Comments in the Regulation, and FDA's Responses. This one, #431, got a raised eyebrow, since it is contrary to what FDA has said elsewhere: "We agree there is a difference in biological activity between synthetic and naturally derived β-carotene. "
In the past FDA would object if any vitamin company said "natural" was better than "synthetic." Does that irrational rule still hold? If your naturally derived nutrient ingredient has been shown to be better than synthetic versions, it seems the old rule may no longer hold.
Friday, April 13, 2018
Thursday, February 15, 2018
With Memes the Medium is the Message
We know from 20th Century media guru Marshall McLuhan that "the medium is the message..."  The medium that carries the information is its own message. That seems especially true of our 21st Century hyper-connected Internet virtual reality.
I recently read Josh Weltman's book Seducing Strangers, which I highly recommend.  In it he makes a fascinating observation, one of many, starting with a term from Aristotle's Rhetoric, "Enthymeme." 
He connects the term to Internet "memes" - a word that was originally a play on the term "gene."  A meme is an idea (embodied as a catchphrase, image or the like) which spreads throughout a society in a fashion not unlike the way genes spread through a population.
The point he makes, and the reason for this blog entry, is that there is a certain pattern to the use of Internet Memes that makes them powerful persuasive tools. "If the first part... confuses, the second part must explain. And if the first part explains, the second part should confuse." 
Aristotle's Enthymeme is a logical construct where the "first term" of the syllogism is assumed to be understood by the listener. The the second and third terms of the argument are more persuasive since the first is already in the minds of the listener.
For Internet image memes this can be generalized to: If the image confuses (or shocks, or astounds or amuses = surprises) then the words should explain; if the image explains, the words should surprise.
To a degree the image above is an example of the process. The retro-image is typical '60s California and carries with it the whole meme complex of California Living. The words pull it into the present, starting with the current year date and become a warning to those doing business in California that the changing rules will impact them and require attention. www.ProfessionalSafetyDossier.com
The average attention span of the average Internet user is very short. Just seconds.  Notice mainstream TV, for example. The editing cuts (especially for ads) are often the length of a heartbeat, sometimes two or three. Hardly ever more.
Thus the Internet Meme, with its rhetorical tension between image and word, is an ideal tool to get the message through the medium and into the minds of your audience.
Internet communication is becoming a battleground of memes. My Millennial Connections tell me they call it The Meme Wars. Some of the most popular Facebook groups are built around what are called "Dank Memes"  The more dissonance between the image and the words, the better. And so it goes.
If the image astounds, the words explain. If the image explains, the words astound...
 https://en.wikipedia.org/wiki/The_medium_is_the_message - "The medium is the message is a phrase coined by Marshall McLuhan meaning that the form of a medium embeds itself in any message it would transmit or convey, creating a symbiotic relationship by which the medium influences how the message is perceived."
 Workman Publishing, 2015 - ISBN 978-0-7611-8495-9 (Co-producer of the TV series, Mad Men)
 https://en.wikipedia.org/wiki/Enthymeme - "An enthymeme (Greek: ἐνθύμημα, enthumēma) is a rhetorical syllogism ... used in oratorical practice."
 https://en.wikipedia.org/wiki/Internet_meme - "In 2013 Dawkins characterized an Internet meme as being a meme deliberately altered by human creativity—distinguished from biological genes and Dawkins' pre-Internet concept of a meme which involved mutation by random change and spreading through accurate replication as in Darwinian selection."
 Weltman, - see page 25.
 http://time.com/3858309/attention-spans-goldfish/ - You Now Have a Shorter Attention Span Than a Goldfish
 https://www.facebook.com/groups/1715753248636816/ - Gary Johnson's Dank Meme Stash
Thursday, February 1, 2018
Monday, January 15, 2018
FDA IS CONCERNED ABOUT QUALITY CONTROL
AND SO SHOULD YOU BE...
Each year it is possible to see the trends in FDA inspections and concerns. This practice note looks at some of the typical letters that show us what those concerns have been in recent months.
There are four main areas that I've noted:
 Citing medical journal "disease claim" articles to support claims is not allowed.
"When scientific publications or references are used commercially by the seller of a product to promote the product to consumers, such references may become evidence of the product's intended use."
 Failure to establish a system of process and production controls must be addressed.
"...a firm that contracts out some or all of its operations must establish a system of production and process controls to ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the master manufacturing record..."
 Making medical claims for DSHEA products is never allowed.
"...regular consumption ... may help stave off disease…." / "...reduced inflammation..."
 Quality Control / QC Manager issues are primary.
"Your quality control personnel failed to ensure that your manufacturing, packaging, labeling, and holding operations ensure the quality of the dietary supplement..."
Here are some more detailed excerpts from the Warning Letters reviewed that show you in detail how FDA approaches these issues, followed by my recommendations.
[A] Vita Purity
(i) Disease Claim Citations
"Your website also includes disease claims in the form of citations to publications or references. When scientific publications or references are used commercially by the seller of a product to promote the product to consumers, such references may become evidence of the product's intended use. For example, under 21 CFR 101.93(g)(2)(iv)(C), a citation of a publication or reference in the labeling of a product is considered to be a claim about disease treatment or prevention if the citation refers to a disease use and if, in the context of the labeling as a whole, the citation implies treatment or prevention of a disease...
(ii) Production and Process Controls
...You failed to establish a system of production and process controls to ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the master manufacturing record (21 CFR 111.55). Specifically, you had no written procedures for the responsibilities of the quality control operations, including written procedures for conducting a material review and making a disposition decision, as required by 21 CFR 111.103, and no written procedures for approving for release, or rejecting, any packaged and labeled dietary supplement (including a repackaged or relabeled dietary supplement) for distribution, as required by 21 CFR 111.127(h).
You receive finished, packaged and labeled dietary supplements from a manufacturer that manufactures the dietary supplements on your behalf (your contract manufacturer). You hold and distribute the dietary supplements. You state that you specify the active ingredients and their proportions for each of your products. You design and approve the product labels and have them printed and shipped to your contract manufacturer. You sometimes procure dietary ingredients and supply them to your contract manufacturer. You state that you assume your contract manufacturer is responsible for preparing a master manufacturing record, exercising quality control functions, and verifying that the finished products meet specifications. You state that you assume your contract manufacturer is complying with 21 CFR Part 111 because you are unaware of any problems at the plant. You state that you do not have a written agreement with your contract manufacturer, and have not performed any audit or engaged in any other activity to determine the acceptability of the manufacturer to manufacture your dietary supplement products, or to ensure the quality of the dietary supplements received and that the products are packaged and labeled as specified in the master manufacturing record.
As a distributor that contracts with a manufacturer to manufacture, package, and label dietary supplements on your behalf that your firm releases for distribution under your firm’s name, your firm has an obligation to know what and how manufacturing, packaging, and/or labeling activities are performed so that you can make decisions related to whether your dietary supplement products conform to established specifications and whether to approve and release the products for distribution. [72 Fed. Reg. 34752, 34790 (Jun. 25, 2007)]. Although a firm may contract out certain dietary supplement manufacturing, packaging, and/or labeling operations, it cannot contract out its ultimate responsibility to ensure that the dietary supplement it places into commerce (or causes to be placed into commerce) is not adulterated for failure to comply with dietary supplement CGMP requirements.  In particular, the Act prohibits a person from introducing or delivering for introduction, or causing the delivery or introduction, into interstate commerce a dietary supplement that is adulterated under section 402(g) for failure to comply with dietary supplement CGMP requirements [see 21 U.S.C. §§ 342(g) and 331(a)]. Thus, a firm that contracts out some or all of its operations must establish a system of production and process controls to ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the master manufacturing record (21 CFR 111.55). The quality control personnel must ensure that the manufacturing, packaging, labeling, and holding operations ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the master manufacturing record (21 CFR 111.105). Further, you must have documentation of the quality control personnel review and approval for release of any packaged and labeled dietary supplement (21 CFR 111.127(h) and 111.140(b)(2))."
[B] Maine Natural Health
(i) Disallowed claims
“Vitamin D [an ingredient in the product] may improve heart health…. heart disease is the leading cause of death in the US, which makes vitamin D an important nutrient.”
“Benefits of fish oil [an ingredient in the product] include: reduced inflammation”
“[T]he omega-3 fatty acids in fish oil [an ingredient in the product]…have shown beneficial results for a variety of health problems….like high blood pressure and arthritis. This means regular consumption of fish oil may help stave off disease….”
(ii) Master Manufacturing Record Required
"You failed to prepare and follow a written master manufacturing record (MMR) for each unique formulation of dietary supplement that you manufacture, and for each batch size, to ensure uniformity in the finished batch, from batch to batch, as required by 21 CFR 111.205(a). Specifically, during the inspection we noted that you are not preparing master manufacturing records that are unique to the batch sizes being manufactured for each of your dietary supplements. For example, our review of your records indicated that on May 5, 2016, you manufactured one batch of Vanilla Recovery Whey Protein using (b)(4) with a final batch size of (b)(4) and on July 5, 2016, you manufactured another batch of the same product using (b)(4) with a final batch size of (b)(4) following the same master manufacturing record for each batch.
Additionally, in preparing your master manufacturing records for all dietary supplements you manufacture, you must ensure that they meet the requirements of 21 CFR 111.210. For example, the current master manufacturing record for [redacted] Whey Protein does not include the strength, concentration, weight, or measure of each dietary ingredient for each batch size, as required by 21 CFR 111.210(a)."
[C] Brain Alert
(i) Ultimate Responsibility for Your Own Labels
"Although a firm may contract out certain dietary supplement manufacturing, packaging, and/or labeling operations, it cannot contract out its ultimate responsibility to ensure that the dietary supplement it places into commerce (or causes to be placed into commerce) is not adulterated for failure to comply with dietary supplement CGMP requirements [see United States v. Dotterweich, 320 U.S. 277, 284 (1943) (explaining that an offense can be committed under the Act by anyone who has “a responsible share in the furtherance of the transaction which the statute outlaws”); United States v. Park, 421 U.S. 658, 672 (1975) (holding that criminal liability under the Act does not turn on awareness of wrongdoing, and that “agents vested with the responsibility, and power commensurate with that responsibility, to devise whatever measures are necessary to ensure compliance with the Act” can be held accountable for violations of the Act)]. In particular, the Act prohibits a person from introducing or delivering for introduction, or causing the delivery or introduction, into interstate commerce a dietary supplement that is adulterated under section 402(g) for failure to comply with dietary supplement CGMP requirements [see 21 U.S.C. §§ 342(g) and 331(a)]. Thus, a firm that contracts with other firms to conduct certain dietary supplement manufacturing, packaging, and labeling operations for it is responsible for ensuring that the product is not adulterated for failure to comply with dietary supplement CGMP requirements, regardless of who actually performs the dietary supplement CGMP operations. "
[D] Dynamic Technical Formulations
(i) Quality Control Personnel
"Your quality control personnel failed to ensure that your manufacturing, packaging, labeling, and holding operations ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the master manufacturing record, as required by 21 CFR 111.105. Specifically, your quality control personnel failed to approve or reject all processes, specifications, written procedures, controls, tests, and examinations and deviations from or modifications to them, that may affect the identity, purity, strength, or composition of a dietary supplement [see 21 CFR 111.105(a)]. Additionally, the personnel you identified to perform quality control operations do not have the education, training, or experience to perform quality control functions, as required by 21 CFR 111.12(c). Specifically, you identified yourself to our investigator as the quality manager, but admitted that you were not familiar with the Dietary Supplement GMPs and had not received any training to perform the duties associated with quality control.
To fulfill the requirements for quality control operations, your firm must establish and follow written procedures for the responsibilities of the quality control operations, including written procedures for conducting a material review and making a disposition decision, as required by 21 CFR 111.103. You must implement quality control operations in your manufacturing, packaging, labeling, and holding operations for producing the dietary supplement to ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the master manufacturing record, as required by 21 CFR 111.65."
BOTTOM LINE -- RECOMMENDATIONS FOR ACTION
We can see from these warnings that the industry is being held to ever higher standards of conduct, as FDA seeks to impose strict Quality Controls. The position of Quality Control Manager is very important. FDA prefers that the QCM is not the Chief Operating Officer, the COO, but reports to, and has immediate access to, the COO and CEO. Each company needs to appoint and train a QCM (and be able to substantiate that training).
My quarter-hour Quality Control webinar (with eBook) covers the duties and qualifications of your QCM. If you want to see my 26 slide presentation, please let me know. I'd be happy to send you the link to the eBook, which has just been posted with the Webinar. If you have access to my Webinar System you can find it there. If not, why not? http://www.vitaminconsultancy.com/webinars.php
These newsletters are archived here: http://vitaminlawyerarchives.blogspot.com/
CALIFORNIA PROP 65 WILL IMPACT YOUR BUSINESS THIS YEAR!