Wednesday, May 15, 2019

Specifications, Testing and Samples. Webinar

April 2019 Newsletter
This Issue:  New STS Webinar and New Product Checklist

The Vitamin Consultancy

STS Webinar

My new STS webinar focuses on three areas from Part IX of the DSHEA GMPs: Specifications, Testing and Samples. Webinar video (27 minutes), ebook and the New Product checklist included.  The Vitamin Consultancy regular retainer clients will automatically receive access to this important webinar.  For all other clients, we have a special (April only) introductory price:  $99 for full access.  Just email me at ralph.fucetola@gmail.com with STS in the subject line and I'll send you a PayPal money request and give you access.


 

NEW PRODUCT CHECKLIST

The essential elements in my new webinar are summarized in the New Product Checklist, consisting of 6 pages. The checklist takes you from the idea for a new product through all the specification, testing and regulatory requirements for a new DSHEA product. The Vitamin Consultancy regular retainer clients have received the checklist. The Checklist is available to all others for a nominal fee of $25. If you want a copy, please email me at ralph.fucetola@gmail.com with "Checklist" in the subject line and I will send you a PayPal invoice.

TIME RAN OUT.

If you think you have enough time to get ready for California's new, tougher, Proposition 65 warning rules, you are wrong. The new rules started 6 MONTHS ago. If you think your product does not get into California, think again. If you think no one will notice, remember that Prop 65 is enforced by a hoard of private lawyers looking to grab fees and penalties from your company. 

More information on how Dr. Goodman and I can help:  www.ProfessionalSafetyDossier.com


Here is my article about all this, posted at Open Source Truth: http://www.opensourcetruth.com/proposition-65-california-ratchets-up-cancer-repro-harm-warning-rules/

Friday, February 15, 2019

February Vitamin Consultancy Newsletter STS WEBINAR


[1] FDA Takes Action Against Products Claiming to Treat Disease

[2] NEW WEBINAR: When must you have batches of your product tested?


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[1] The journalists at Vitamin Retailer have been investigating FDA's latest actions and report "On Feb. 11, the U.S. Food and Drug Administration (FDA) posted 12 warning letters and 5 online advisory letters to foreign and domestic companies that are illegally selling more than 58 products, many that are sold as dietary supplements, which are unapproved new drugs and/or misbranded drugs that claim to prevent, treat or cure Alzheimer’s disease and a number of other serious diseases and health conditions." https://vitaminretailer.com/fda-takes-action-against-products-claiming-to-treat-disease-seeks-to-strengthen-oversight/

Looking more closely at the warning letters and actions, we find that they are mostly about the "claims" being made, not the ingredients (though some disreputable companies have adulterated their vitamin products with unapproved drugs).  The lesson:  be careful what you claim.  Be very careful about the words you use to describe those claims!  For example, one of the valid nutrient ingredients mentioned was Alpha GPC (L-Alpha glycerophosphocholine) --not because it is a "drug" -- but because the claims made were about treating cognitive impairment medical conditions.

The article reports that FDA Commissioner Scott Gottlieb, MD said, “Today’s actions are part of the FDA’s larger effort to address the booming growth of the dietary supplement industry through the implementation of modern regulatory initiatives that will enable the agency to preserve the balanced vision of the Dietary Supplement Health and Education Act (DSHEA), enacted by Congress 25 years ago. That law sought to achieve the right balance between preserving consumers’ access to lawful
supplements, promoting innovation in these products, while upholding our obligation to protect the public from unsafe and unlawful products and holding accountable those actors who are unable or unwilling to comply with the requirements of the law. Our newest policy efforts will seize the game-changing opportunity to further strengthen the regulatory framework overseeing dietary supplements and will hone in on important steps to both promote industry innovation while upholding the safety of these products as part of our overall commitment to protecting public health.”

Bottom Line:  pay attention to the words you use to state your claims... and have the Vitamin Consultancy review them before you communicate to the public!

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STS WEBINAR & EBOOK

[2] Here is a Practice Question I often receive from my Vitamin Consultancy clients.

Does FDA require that the Label Owner of a DSHEA Dietary Supplement have finished product batch-tested [in addition to verifying the ingredients]?

Yes.  Here are the batch testing concerns from Subpart C of the GMP regulations:

1.  That the product meets the specifications for the product in 6 specific areas - 21 CFR 111.75(a) through (g)
2.  That an expiration date, if any, is scientifically valid [Such a date is not required by FDA, so I do not recommend expiration dates]
3.  Specific types of tests required - 21 CFR 111.75(h)(2)
4.  Must test for: identity, purity, strength, composition, and the limits on types of contamination that may adulterate - 21 CFR 111.75(c) & (d)
5.  Every finished batch must be tested - 21 CFR 111.75(c)
6.  There are certain exemptions - 21 CFR 111.75(d)

In addition to testing concerns, Part IX also addresses Specifications and Samples. You have to determine what your specifications are for 7 specific areas set forth in Subpart B and, under Subpart C, you have to determine whether your product meets the specifications in 6 specific areas listed there.

Comparison of Subpart B and C Specification Requirements:

B.  Required to Establish

1. control point specifications
2. components
3. in-process
4. labels and packaging
5. finished batch
6. received for packaging and labeling
7. finished product packaging and labeling

C.  Required to Determine Product Meets

1. components
2. in-process
3. finished batch
4. received for packaging and labeling
5. labels and packaging
6. finished product packaging and labeling

[Subpart A is about "General Requirements" and Subpart B is about Requirements to Establish Specifications; Subpart C is about testing. Subpart D* is about specifications and verification of dietary ingredients and Subpart E is about representative and reserve samples]

My new Specifications, Testing and Sampling (STS) Webinar and eBook cover these matters in greater detail with references to the specific regulations and standards required.  Email me with "STS Webinar" in the subject line and we can arrange your access to the webinar and its accompanying ebook.

As always, of course, my monthly retainer clients will automatically receive access to this new Webinar and eBook as soon as they are posted.

Tuesday, January 22, 2019

It's a New Year - Time to Audit Your Compliance to Changing Regulations

It's a New Year - Time to Audit Your Compliance to Changing Regulations
Your Company MUST have a PCQI
New Food Safety Training Webinar

FDA's Food Safety Regulation requires a written plan and a trained PCQI - Preventative Controls Qualified Individual. I have you covered.

I prepared a 15 page Food Safety Plan that closely tracks the Regulation, 21 CFR 117.126. Then I prepared an 18 minute training webinar and eBook, along with a certification test. If you pass, you receive a PCQI Certification of Completion of the training.

The Certification Training Program is structured to introduce the trainee to a standard Food Safety Plan under FDA regulations. All registered food facilities are required to have a written Food Safety Plan in place and in operation. After completing the webinar and reviewing the Food Safety Plan Format and the eBook, contact me to receive the Certification Test, and upon completion and return of the test, the Preventative Controls Qualified Individual (PCQI) Certification will be provided.

Is your company required to register as a food facility [and is therefore required to have a Food Safety Plan]? If you handle food, yes.

This certification program, including the Food Safety Plan, eBook and webinar training, is priced at $600 -- but, for recipients of the Vitamin Consultancy Newsletter, I am offering a 50% Discount, if purchased during the month of January, 2019. Just email me at: ralph.fucetola@usa.net with "FSP" in the subject line.

Says the FDA: “The Food Safety Modernization Act of 2011 (FSMA) directs the Food and Drug Administration (FDA) as the food regulatory agency of the U.S. Department of Health and Human Services to better protect public health by, among other things, adopting a modern, preventive, and risk-based approach to food safety regulation. On September 17, 2015, FDA published the final rule Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food (PCHF rule) (80 FR 55907). This final rule became effective on November 16, 2015. It creates new requirements for the production of human food by registered food facilities... The intent of this guide is to inform domestic and foreign food facilities about the PCHF regulation and enable them to better understand the requirements of the rule. The rule is binding and has the full force and effect of law.”

The Regulation provides that the Plan shall contain the following Contents:
(1) The written hazard analysis as required by § 117.130(a)(2);
(2) The written preventive controls as required by § 117.135(b);
(3) The written supply-chain program as required by subpart G of this part;
(4) The written recall plan as required by § 117.139(a);
(5) The written procedures for monitoring the implementation of the preventive controls as required by § 117.145(a)(1);
(6) The written corrective action procedures as required by § 117.150(a)(1); and
(7) The written verification procedures as required by § 117.165(b).
The Plan has 22 separate sections. The PCQI must be a manager of the company and must be trained, with proof of training.

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Horizon v Jonuzi et al. 
Last month the case survived a Summary Judgment Motion.

This may be the most important lawsuit pending in the USA regarding Insurance Industry reimbursement for holistic and integrative treatments and therapies... including dietary supplements as Medical Foods. This pending litigation can construe the Affordable Care Act to forbid insurance carrier discrimination against holistic and integrative practitioners, permitting proper insurance coding for such therapies.

From the standpoint of the Mission of the Institute, this change would facilitate retrospective research into holistic and integrative modalities (through coding statistics). That's why the Institute for Health Research is sponsoring crowdfunding support for the litigation. [Note: I am not the attorney of record on this case.]

Read more here: https://vitaminlawyerhealthfreedom.blogspot.com/2018/12/provider-nondiscrimination-case.html

Please read about it, and help our crowdfunding effort. This case is quite important!

Donate here: https://fundly.com/support-natural-therapies

And while you are at it... remember the Institute is now sponsoring a holistic and integrative IRB program for all you researchers. www.inhere.org/institutional-review-board/