Thursday, February 15, 2018

The Meme Wars

With Memes the Medium is the Message

We know from 20th Century media guru Marshall McLuhan that "the medium is the message..." [1] The medium that carries the message 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. [2] In it he makes a fascinating observation, one of many, starting with a term from Aristotle's Rhetoric, "Enthymeme." [3]

He connects the term to Internet "memes" - a word that was originally a play on the term "gene." [4]  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." [5]

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. [6] 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" [7] 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...


-----------

[1] 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."

[2] Workman Publishing, 2015 - ISBN 978-0-7611-8495-9 (Co-producer of the TV series, Mad Men)

[3] https://en.wikipedia.org/wiki/Enthymeme - "An enthymeme (Greek: ἐνθύμημα, enthumēma) is a rhetorical syllogism ... used in oratorical practice."

[4] 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."

[5] Weltman, - see page 25.

[6] http://time.com/3858309/attention-spans-goldfish/ - You Now Have a Shorter Attention Span Than a Goldfish

[7] https://www.facebook.com/groups/1715753248636816/ - Gary Johnson's Dank Meme Stash

Thursday, February 1, 2018

California Prop 65 Services

CALIFORNIA REGULATIONS IMPACT ALL BUSINESSES


California's Proposition 65 changes will cost you money.  You can hire Dr. Goodman and me to manage the changes, or you can risk large fines and legal expenses if you do nothing. Act today!
 

Remember, even if you do not sell directly into California, so long as your product or service is used in California, the regulation applies.


Are you required to give the Prop 65 Warning? If you are and you fail to do so, any California consumer can sue you in California, recover legal fees and get a share of the fine for bringing the case... there is a growing cottage industry in California where people identify and sue unsuspecting companies... like yours!

Go to http://www.ProfessionalSafetyDossier.com and learn how we can help you avoid a costly mistake. Check our FAQs page there.

Robert Goodman, PhD (Biochemistry) and I will search the 900 chemicals on the Prop 65 List and if you have one of those ingredients, determine if you have under the "Safe Harbor" limit or otherwise are below the No Adverse Reaction Level and then Certify that you do not need to give the warning. Unless you do... But, remember, there are loopholes within the loopholes.

Here is the link to a short video explaining our services:  
https://youtu.be/qm6aQnlaKk8

Monday, January 15, 2018

FDA 2017 WARNING LETTERS


FDA IS CONCERNED ABOUT QUALITY CONTROL
AND SO SHOULD YOU BE...


Over the year I see a number of FDA Form 486 Inspection Observations and Warning Letters. It is my practice in January to look back at the FDA's published Warning Letters as well. They are published here: https://www.fda.gov/iceci/enforcementactions/warningletters/2017/default.htm

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:

[1] 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."

[2] 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..."

[3] Making medical claims for DSHEA products is never allowed.

"...regular consumption ... may help stave off disease…." / "...reduced inflammation..."

[4] 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. [1] 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))."

https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm559804.htm

[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)."

https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm590003.htm

[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. "

https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm589575.htm

[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."

https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm589584.htm

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/



THE CLOCK IS TICKING... 
CALIFORNIA PROP 65 WILL IMPACT YOUR BUSINESS THIS YEAR!

Tuesday, January 2, 2018

UK and USA Governments Attack Homeopathy and Herbal Remedies


FDA ATTEMPTING TO KILL HOMEOPATHY [HERBS NEXT!]
IN ILLEGAL ACTION WE MUST STOP!
The UK's National Health "Service" used to run special homeopathic hospitals and herbal dispensaries. Not any more, now that the "one payer" will no longer pay for either and they are being closed. [1]

Unsurprisingly, the FDA is following suit, despite the fact that Homeopathy and the US Homeopathic Pharmacopoeia (USHP) are protected by specific statutes in the US.

Did Health Freedom end when 2017 made its exit? Yes, if the FDA has its way!

Bottom Line: If you and your company are ready to take action to protect natural remedies, read on, then email me:

We have until March 20th to file formal comments with FDA.  Docket FDA-2017-D-6580 -- comment here: https://www.federalregister.gov/documents/2017/12/20/2017-27157/drug-products-labeled-as-homeopathic-draft-guidance-for-food-and-drug-administration-staff-and

This past year the DEA and the FDA came out publicly saying, for example, that Cannabidiol, CBD, a neurotransmitter produced by mammalian (including human) bodies, was not a lawful nutrient, although the agencies have stopped short of raiding health food stores [as FDA used to do in the 1990s, before the Dietary Supplement Health and Education Act (DSHEA)] to enforce their dictate. [2] 

Right now, although there is a century of laws protecting homeopathy, FDA is attacking homeopathy to “protect” you. They are the government and they are here to "help" — Big Pharma.

On December 18th of this past year FDA issued new regulations that attack homeopathic oral and injectable remedies despite the fact that they are protected by long-standing law. This blatant attack on your health freedom choices is part of a long-term, well-financed conspiracy and, sadly, comes as no surprise. [3]

On your behalf we told FDA, when they started their “regulatory review” of homeopathy to let our natural remedies alone! The attack began “innocently enough” during the previous presidential administration.  FDA asked for comments on how it should “modernize” homeopathy regulations. That’s the government’s first step toward ratcheting-up control. That’s the step to which we had previously replied, telling them, among other things:

"FDA does not have authority from Congress to interfere with traditional homeopathy, nor does Congress have authority to permit such interference. Individuals have the right, under international humanitarian law binding on the United States, of Informed Consent to exercise their Freedom of Choice in health care without government burdening that fundamental right." [4] 

These new regulations followed similar recent action in the UK by its “one payer” nationalized health care system. The UK National Health “Service” has ended its long-standing history of support for safe, gentle and effective homeopathy and herbalism (the UK even has special homeopathic hospitals and homeopathic/herbal dispensaries) in favor of dangerous, deadly and ineffective pharmaceuticals. This trend for medical tyranny has “crossed the pond” as the FDA has attacked legally protected homeopathy in the USA.

This was done in three steps that I have documented. 

First in 2015, when the FDA asked for public comments about regulating homeopathy. That's when we submitted the comments referenced above. By the way, by submitting comments telling FDA they were acting illegally, we preserved the legal right to complain to the courts; we preserved "standing to sue."

Second, as noted in a blog entry I posted last January, FDA was toying with the idea of requiring "disclaimers" on homeopathic products, disclaimers not required by the statute that protects homeopathy in the USA [5].

Third, the most recent action, which illegally attempts to treat HPUS standard homeopathic remedies as unapproved pharmaceutical drugs, requiring a "risk/benefit analysis" which will effectively ban many, if not most, homeopathic remedies. This pseudo-scientific analysis starts with the false claim that homeopathic remedies have no benefit and alleges a "risk" that people using such remedies will fail to use Big Pharma's government approved, dangerous, "side-effect" drugs. 

Such a risk! Since government approved drugs are the main cause of preventable death in the USA, what risk? [6]

The natural product industry has two choices: let Big Pharma and the globalists have their way or force them back, step by step.  I am sure that large producers of homeopathic remedies will have no choice but to challenge the regulation.  

Since we have preserved the right to object to this latest FDA action, cooperation between the industry and the health freedom movement during 2018 may be the only way to preserve our access to homeopathy, and, while dodging the FDA's left punch, we'll need to watch it's right arm for the next attack on herbs and other nutrients, like CBDs.  

The new President, failing to keep his promise to "drain the swamp" seems to be appointing swamp-creatures to run the FDA and empower it to further attacks!

We must choose to force them back. I know you will want to do so, too.  

To start, use and share this link to make your opinion about the FDA attack heard:   https://fans.vote/ACsU7n6KLLo  


Download, print and post this poster at your local health food store:



Then take these steps:

1. Make a generous, tax deductible donation now to Institute for Health Research, here:   http://www.InHeRe.org

2. Show your support directly to the Natural Solutions Foundation as a potential litigant against the FDA (not tax exempt) here:  https://www.nsfmarketplace.com/product/support-the-work-of-natural-solutions/

3. Contact me directly if you or your company want to be part of the advocacy and litigation that will likely be needed to stop this latest FDA outrage. Our half century of health freedom advocacy positions us to coordinate this urgent action. Email me here: ralph.fucetola@usa.net


4.  File your comments here: https://www.federalregister.gov/documents/2017/12/20/2017-27157/drug-products-labeled-as-homeopathic-draft-guidance-for-food-and-drug-administration-staff-and

——————–

[1]  
http://www.telegraph.co.uk/news/2017/07/21/nhs-ban-homeopathy-herbal-medicine-misuse-resources/


[4]  We told FDA to leave our natural remedies alone; when they started this latest attack on Homeopathy, back in 2015, here are the comments I filed with FDA: http://vitaminlawyerhealthfreedom.blogspot.com/2015/06/comments-to-fda-re-homeopathy-fda-has.html

Sunday, October 29, 2017

California Increases Prop 65 Regulation Controls

Proposition 65: Carcinogenic Chemicals Notification
California Increases Regulation Controls



In 1986 California voters adopted Proposition 65,

“That initiative became the Safe Drinking Water and Toxic Enforcement Act of 1986, better known by its original name of Proposition 65. Proposition 65 requires the State to publish a list of chemicals known to cause cancer or birth defects or other reproductive harm. This list, which must be updated at least once a year, has grown to include approximately 800 chemicals since it was first published in 1987. Proposition 65 requires businesses to notify Californians about significant amounts of chemicals in the products they purchase, in their homes or workplaces, or that are released into the environment.”

Since California is a major part of the US economy, as a practical matter, all businesses selling across state lines find that they must conform to the California law, or provide special California labeling for products shipped to sold in California.

The List of chemicals is here; https://oehha.ca.gov/proposition-65/chemicals
There are certain limits on the disclosure rule.

“Businesses with less than 10 employees and government agencies are exempt from Proposition 65’s warning requirements ... Businesses are also exempt from the warning requirement …  if the exposures they cause are so low as to create no significant risk of cancer or birth defects or other reproductive harm...”

“No significant risk” means less than one chance in a 100,000 of causing cancer, or one in 1,000 of causing reproductive harm.

The California government has published “safe harbor” numbers for some substances on the List to guide businesses in determining their responsibilities, here:
https://oehha.ca.gov/proposition-65/general-info/current-proposition-65-no-significant-risk-levels-nsrls-maximum.

The question businesses must consider is whether any chemical in the product is in “significant amounts” and must therefore be disclosed by a Notice on the label or if the “exposures” are so low as to “create no significant risk...” and thus no duty to warn.

If the ingredient is one of the named ingredients on the label and it is on the List then, clearly, the Notice is required.

If the substance is a named ingredient, but is only incidentally present, or is used only in process, the question remains: is there a significant amount to disclose?

California reminds businesses:

“Although a business has the burden of proving a warning is not required, a business is discouraged from providing a warning that is not necessary and instead should consider consulting a qualified professional if it believes an exposure to a listed chemical may not require a Proposition 65 warning.”

When a Warning is required, it must be “clear and reasonable”
https://oehha.ca.gov/media/downloads/crnr/art6regtextclean090116.pdf

In January 2017 California changed the safe harbor rules for when a Warning is “clear and reasonable.

One online source reported:

“The new regulations now require that the safe-harbor warning include the word “WARNING” in all capital letters and bold print and further require that a symbol consisting of a black exclamation point in a yellow equilateral triangle with a bold black outline precede the warning.  The new regulations further specify different safe-harbor warnings for products that contain only carcinogens, only reproductive toxicants, both listed carcinogens and listed reproductive toxicants, or a listed chemical that is both a carcinogen and reproductive toxicant.” http://www.klgates.com/warning-proposition-65-warning-requirements-have-changed-01-04-2017/

Here is how a compliant warning will look when the new regs are fully enforced:



Happily there is a simpler “on bottle” warning that can be used at least for the time being.



In addition to the on the label Warning, the new regs address online warnings:

“To comply with the safe-harbor provisions for Internet purchases, the new regulations require companies to include the safe-harbor warnings on the product display page, in a hyperlink using the word “WARNING” on the product display page, or by otherwise prominently displaying the warning to the purchaser prior to completing the purchase.”

In summary, the new regs will direct consumers to a special P65 government web page. It will be important to make sure that required link opens in a new tab, so the potential customer will not lose the purchase page while looking at the Warning.

Further, going forward, when you give the required Warning, you must also name the chemical(s) for which the warning is given. You will need accurate tests and a clear Proposition 65 Plan.

The new regulations are fully effective on August 30, 2018 for any product manufactured after that date.

The sooner companies get ready, the better! The Vitamin Consultancy will offer Proposition 65 “No Significant Risk” Dossiers, similar to our Cosmetic Safety Dossier – www.CosmeticSafetyDossier.com – to enable compliance with the law, by either complying with the Warning requirement or by having the assurance that the substances pose no significant risk.


The Vitamin Consultancy Archives are here:
http://vitaminlawyerarchives.blogspot.com/
The Vitamin Health Freedom Blog is here:
http://vitaminlawyerhealthfreedom.blogspot.com/


Saturday, September 9, 2017

Intentional Adulteration Defense

Intentional Adulteration Defense
Online Free Trade Certificate

Newsletter of 09 September 2017
INTENTIONAL ADULTERATION
FOOD DEFENSE

Guidance for Industry
Mitigation Strategies to Protect Food
Against Intentional Adulteration -
What You Need to Know About the FDA Regulation:
Small Entity Compliance Guide

https://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/ucm562216.htm

Congress adopted the Food Safety [sic] Modernization Act (FSMA) in 2010 (I was involved in the successful effort to protect DSHEA from some of the provisions of the act). Among other steps, the Act directed the Food and Drug Administration (FDA) as the food regulatory agency of the U.S. Department of Health and Human Services to, as FDA states, "better protect public health by, among other things, adopting a modern, preventive, and risk-based approach to food safety regulation."

On May 27, 2016, FDA published a final rule, Mitigation Strategies to Protect Food Against Intentional Adulteration (IA rule) (81 FR 34165), that, the Agency states, "creates new requirements for the production of food by registered food facilities to protect the food supply against intentional adulteration. "

Posted on August 24, 2017 FDA issued a Small Entity Compliance Guide in accordance with section 212 of the Small Business Regulatory Enforcement Fairness Act (Public Law 104-121, as amended by Public Law 110-28). FDA says, "This guidance document is intended to assist small entities in complying with the rule set forth in 21 CFR 121 concerning Mitigation Strategies to Protect Food Against Intentional Adulteration. The rule is binding and has the full force and effect of law."

The good news is that the Guide gives companies several years to comply with the more stringent regulations.

You can read the entire Guide here: https://www.fda.gov/downloads/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/UCM562223.pdf or you can subscribe to the Vitamin Consultancy's OPS -- Operating Procedures System, to be assured of haveing the tools you need to be in compliance.

Here is what the FDA says is the Primary Requirement:

"The rule requires a written food defense plan for all covered facilities ... (21 CFR 121.5). The written plan must include (21 CFR 121.126):

    • A vulnerability assessment to identify -
        significant vulnerabilities and
        actionableprocess steps,
        and associated explanations
    • Mitigation strategies and associated explanations
    • Procedures for food defense monitoring
    • Procedures for food defense corrective actions
    • Procedures for food defense verification"

Therefore, primarily, you will need to adopt and implement an Intentional Adulteration Avoidance SOP that meets the Primary Requirement and others set out in the Guide. Drafted by the Vitamin Consultancy's experts, you can rest assured that this new Standard Operating Procedure will both meet the letter of the law and be structured so your company can implement effectively within the OPS system.

For more on OPS 4 SOPs, see my new videos posted here:http://vitaminlawyerarchives.blogspot.com/2017/08/three-new-vitamin-consultancy-videos.html

Email me to bring your company into the modern OPS era. ralph.fucetola@usa.net

---------------------------------

New Free Trade Certificate  -- https://www.access.fda.gov/oaa

https://www.fda.gov/Food/NewsEvents/ConstituentUpdates/ucm541785.htm

Starting earlier this year Certificates of Free Sale (COFS) for food products regulated by the U.S. Food and Drug Administration’s Center for Food Safety and Applied Nutrition (CFSAN) will be issued online as downloadable PDFs. The change from paper to PDF certificates will make the process of issuing COFS more efficient for both exporters and the agency.

Review of a certificate may be required by foreign countries as part of the process to import a product into those countries. FDA issues COFS for certain CFSAN-regulated food products upon request by an exporter. FDA does not require export certificates to export foods to foreign countries.

The FDA Certificate Application Process (CAP) is CFSAN's web-based application for accepting requests, reviewing, processing, managing, tracking, and administering CFSAN export certificates. To access CAP, log in to FDA Industry Systems at https://www.access.fda.gov/oaa and select the "Certificate Application Process" option from the list of systems available. If you do not have an account with FDA Industry Systems, you will need to create one.

The advantages of CAP include:
  • Online submission of applications;
  • Reduction in application processing time;
  • Online receipt of certificates via PDF;
  • Real-time status updates via email and online tracking; and
  • Ability to copy, edit, and resubmit applications.

If exporters are unable to use the new PDF system, they may contact FDA and we will provide assistance.

CFSAN COFS will have a new look, including an updated letterhead and image of the HHS seal. PDF certificates issued directly to the applicant are considered original certificates and the Department of State is able to authenticate the certificates. For each certificate, FDA will provide a unique Certificate Identifier (ID). Foreign government officials authorized by the FDA can use this Certificate ID to verify the authenticity of the certificate. Exporters will need to ensure that the printed certificates are clear and legible. An example of the new look of the certificate is below.

If you have any questions or concerns, please email CFSANExportCertification@fda.hhs.gov or call 240-402-2307.

Friday, August 18, 2017

Three New Vitamin Consultancy Videos

Three New Videos Updating Regulations
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3 Vitamin Consultancy Videos

My summer blockbusters will help preserve your natural product business.  Three videos -- two of which are my gift to you for being on this email list -- are Continuing Education (CEs) for the natural products industry.

The first features Robert Goodman PhD and me talking about our Cosmetic Safety Dossier service. In both the US and the EU third party safety certifications are an important part of successful cosmetics marketing. You can see the video on the CSD web site; click here:
 

The second is my explanation of the new OPS -- the Operating Procedures System -- which makes it simple to use your company's SOPs to actually run the business efficiently and in compliance with FDA requirements. This training video will be added to the Vitamin Consultancy Webinar system, but here it is for you now, gratis. Click here:
 

The third is my new Webinar on Quality Control The 26 slide presentation covers both FDA QC requirements and the qualifications needed for your QC Manager. Don't have a QCM? You need to watch this video. If you are the person who acts as QCM in your company, you need to watch it even moreso! Please email me for access: ralph.fucetola@usa.net with QC Webinar in the subject line.

Have a great balance of the summer... winter holiday marketing starts soon!

Regards,
ralph ...
Ralph Fucetola JD