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.

-----------------------
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/

Monday, December 3, 2018

Year End 2018 Newsletter



Note: notice, notification: private and confidential . . . . . .
Year-End Round-Up: More Happenings That Impacts Your Business.
From Conscience to Miracles... the Vitamin Consultancy has News for You.
-----
Here Are Some
News Items of Interest
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Update on my experience with Dr. Wolf's "Divine Wellness" ethically harvested ovine placenta, CBD and Nano Gold supplement.  

The apparent lesion on my chest continues to heal and the new skin that's grown back over seems normal.  This is an "off label" topical use of a DSHEA supplement product.

Here is the link to this product:   https://www.divinewellnessclub.com/idevaffiliate/idevaffiliate.php?id=103

You can see the original note in last month's email here:   http://vitaminlawyerarchives.blogspot.com/2018/11/keeping-up-with-agency-regulations.html [article 4.1]

BTW, Dr. Wolf is coming out with a version of the product without CBD or hemp oil.
-----
Philanthropic Credit Grants --
May Be Considered
A Private Barter Facilitation System

Sponsored by a private sovran church association, PCs may be the private currency of the future.  For a limited time the organization is granting 5,000 units to each individual, just for signing up.

I URGE YOU TO SIGN UP NOW:  https://www.philanthropicbank.info/ 

Go to "Register" at upper right corner.
-----
VICTORY IN PROVIDER DISCRIMINATION CASE!

I am one of the experts working with the defense in the NJ case of Horizon v Jonuzi et al.  Horizon (BlueCross/Blue Shield) sued Atlantic Integrative Medical Center for "fraud" although not one client of the center complained.  These insurance fraud cases usually end with capitulation by the provider, or by way of a Summary Judgment Motion, in favor of the insurer.  Horizon brought the SJM -- and last week, lost the motion!  Defendants' lawyer said he cannot remember another case where the defense survived this type of attack!

What this means is that this case may be a proper vehicle to test the extent of the Affordable Care Act's "provider nondiscrimination" clause -- this case may set a precedent forcing insurers to cover holistic and integrative care!

We need your help to effectively present this defense and counterclaim.  Donate here:  https://fundly.com/support-natural-therapies/

-----
New HHS Guidance

Says the Acting HHS Secretary:  "For too long too many of these healthcare practitioners have been bullied and discriminated against because of their religious beliefs and moral convictions leaving many of them to wonder whether they have a future in our healthcare system.  When faithful Americans are bullied out of the public square and out of public service, when bigotry is allowed to flourish, we all lose."

This article covers the story:  https://explainlife.com/trump-lays-groundwork-to-ban-mandatory-vaccinations-across-u-s-2730/

And here is the new Disclosure Statement any company, hospital, or agency that gets Federal Funding needs to give to its employees:

DEPARTMENT OF HEALTH AND HUMAN SERVICES
45 CFR Part 88
[Docket No.: HHS–OCR–2018–0002]
RIN 0945–ZA03
Protecting Statutory Conscience Rights in Health Care; Delegations of Authority
AGENCY: Office for Civil Rights (OCR), Office of the Secretary, HHS.
https://www.gpo.gov/fdsys/pkg/FR-2018-01-26/pdf/2018-01226.pdf

Appendix A to Part 88—Notice Concerning Federal Health Care Conscience and Associated AntiDiscrimination Protections

[Name of recipient, the Department, or Department component] complies with Federal health care conscience and associated anti-discrimination laws and does not exclude, treat adversely, coerce, or otherwise discriminate against persons or entities on the basis of their religious beliefs or moral convictions. You have the right to decline to participate in, refer for, undergo, or pay for certain health care-related treatments, research, or services (such as abortion or assisted suicide, among others) which violate your conscience, religious beliefs, or moral convictions under Federal law.

If you believe that [Name of recipient, the Department, or Department component] has failed to accommodate your conscientious, religious, or moral objection, or has unlawfully discriminated against you on those grounds, you can file a conscience and religious freedom complaint with the U.S. Department of Health and Human Services, Office for Civil Rights, electronically through the Office for Civil Rights Complaint Portal, available at https://ocrportal.hhs.gov/ocr/portal/lobby.jsf or by mail or phone at: U.S. Department of Health and Human Services, 200 Independence Avenue SW, Room 509F, HHH Building, Washington, DC 20201, 1–800–368–1019, 800–537–7697 (TDD).

Complaint forms and more information about Federal health care conscience and associated anti-discrimination laws are available at http://www.hhs.gov/conscience.

Dated: January 18, 2018.
Eric D. Hargan,
Acting Secretary, Department of Health and
Human Services.
[FR Doc. 2018–01226 Filed 1–19–18; 11:15 am]
-----
TIME RAN OUT

California's new, tougher, Proposition 65 warning rules are in effect. 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/

Systems Processing Integration


Check out my new web site for my OPS 4 SOPs System.  This is the site you need to organize your basic Branding and Regulatory documents.  www.SystemsProcessingIntegration.com 

Sunday, November 11, 2018

Keeping Up with Agency Regulations

November Vitamin Consultancy eNewsletter
Keeping Up with Changing Regulations

[1] FDA on "Natural"

https://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/LabelingNutrition/ucm456090.htm

"Although the FDA has not engaged in rulemaking to establish a formal definition for the term "natural," we do have a longstanding policy concerning the use of "natural" in human food labeling. The FDA has considered the term "natural" to mean that nothing artificial or synthetic (including all color additives regardless of source) has been included in, or has been added to, a food that would not normally be expected to be in that food. However, this policy was not intended to address food production methods, such as the use of pesticides, nor did it explicitly address food processing or manufacturing methods, such as thermal technologies, pasteurization, or irradiation. The FDA also did not consider whether the term "natural" should describe any nutritional or other health benefit."

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

[2] FDA GMPs -- TEN YEARS OLD

The Natural Products Association is engaging in a tenth year review of the FDA dietary supplement GMPs.  Some valuable information is being developed.  One bottom-line point:  there is a new FDA emphasis on adequate Quality Assurance, which means specific staff members tasked with that role.  QA must sign off on all product batches and the person signing off must not be the person overseeing the production.  This applies to both manufacturers and to the label-owner who is expected to "be in a state of control."

For example, a recent warning letter to a label owner which was sent to me for review cited two violations of QA
"1. Your quality control operations did not include determining whether each finished batch conforms to established product specifications.

2. Your quality control operations did not include approving and releasing, or rejecting, each finished batch for distribution."
Remember, these points were raised directly with the label-owner, not the manufacturer.  Bottom line:  Do you have Product Specifications? Do you have a person responsible for QA?  Is QA included in your SOPs.

My retainer clients are compliant. Are you?  www.SystemsProcessingIntegration.com

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

[3] FDA Mandatory Food Recall Authority

November 5, 2018 - The U.S. Food and Drug Administration has released a final guidance regarding the agency’s mandatory recall authority under the FDA Food Safety Modernization Act (FSMA).

"The 2011 food safety law gave FDA mandatory recall authority for foods if there is a reasonable probability that the food is adulterated or misbranded under certain FDA authorities, and that the food could cause serious illnesses or death. FDA must give the responsible party an opportunity to conduct a voluntary recall before ordering a mandatory recall. Prior to the enactment of FSMA, FDA could only rely on manufacturers to voluntarily recall certain potentially harmful food products.

https://www.federalregister.gov/documents/2018/11/06/2018-24247/guidance-questions-and-answers-regarding-mandatory-food-recalls

Comment: you may recall that Dr. Laibow and I fought hard in 2010 and 2011 to preserve Section 1011 of the food "safety" bill, a section that exempted DSHEA dietary supplements from the "enhanced" authority of the law.  We were denigrated when we worked through one late-nights weekend to get over 150,000 emails to the congressional conference committee, assuring that the exemption clause would stay in the law.  Now we see the results:  "mandatory" recalls based on mere "reasonable probability..." will become the norm for most foods, but not for DSHEA products!

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

[4] TWO IMPORTANT STORIES YOU WON'T SEE ANYWHERE ELSE!

[1] What Happened to that Sore on My Chest?

I love to tell my list about success stories in the natural products market.  Dr. Walter Wolf is one of those geniuses that I've had the privilege to know.  He is an alchemist and naturopath.  His new product, Divine Wellness, is amazing!

Ethically harvested ovine placenta, CBD hemp oil and Nano Gold.  This is an immune boosting rejuvinater nutrient combination.

But I want to tell you about an "off label" use of the product.  A few months ago I noticed a "beauty mark" on my chest had begun to enlarge and become lesion-like. That was concerning so I started putting a varying combination of CBD hemp oil, apricot seed extract, tea tree oil and nano silver on it.  The growth stopped, but it remained.  Then, a few days ago, I begin putting Divine Wellness on the spot.

As the series of images show, it quickly puffed-up, became quite dark, and is now flaking-off.


Amazing!  Learn more about this natural product as a dietary supplement here:  https://www.divinewellnessclub.com/idevaffiliate/idevaffiliate.php?id=103  -- yes, you can join the affiliate program.

[2] Horizon v Jonuzi et al. 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 I've helped to set up a crowdfunding effort.

Read more here: http://www.inhere.org/2018/11/06/making-health-insurers-follow-the-rules/

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.  http://www.inhere.org/institutional-review-board/

My experience will strengthen your company!  I provide private and confidential, competent electronic professional consulting to my Dietary Supplement and advanced healthcare ("CAM") modality clients, for the purpose of compliance with International, State and Federal (including FTC and FDA) standards for communicating about the advertising and sale of dietary supplements (including medical foods) and/or providing of health care services and information. You should consider my SOP / cGMP Certification Course, allowing start-up and established vitamin companies and practitioners who own their own private labeled products to meet with new FDA procedural regulations.

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 2 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/




Sunday, September 30, 2018

Your Food Safety Plan - September 2018 Newsletter

September 2018 Newsletter


Your Food Safety Plan

Two years ago the FDA promulgated new food safety rules, citing the risks of terrorism and food-carried disease. The time to adopt a formal Food Safety Plan is running...

If you handle food in your facility, you need a written Food Safety Plan.  If you contract with a company to manufacture for you, as the label-owner, you must be in a "state of control" which means, you need to know and document that your contract manufacturer has a Food Safety Plan.  That's your responsibility according to FDA.

I've prepared a carefully structured Food Safety Plan Format, directly from 21 CFR 117 -- the food safety regulation.  


Contact me to obtain your Food Safety Plan:  ralph.fucetola@usa.net

Here is the outline of the Food Safety Plan requirements:

The Regulation says the Plan shall contain the following Contents:

(1) Hazard analysis - § 117.130(a)(2)
(2) Preventive controls - § 117.135(b)
(3) Supply-chain program - subpart G
(4) Recall plan - § 117.139(a)
(5) Procedures for monitoring the controls implementation - § 117.145(a)(1);
(6) Corrective action  - § 117.150(a)(1); and
(7) Verification procedures - § 117.165(b).


The Contents of
My Food Safety Plan Format


[1] Status.
[2] Hazard analysis.
[3] Hazard identification.
[4] Hazard evaluation.
[5] Preventive controls.
[6] Process controls.
[7] Food allergen controls.
[8] Sanitation controls.
[9] Supply-chain controls.
[10] Recall plan.
[11] Other controls.
[12] Preventive control management components.
[13] Monitoring.
[14] Corrective actions and corrections.
[15] Verification.
[16] Validation.
[17] Verification of implementation and effectiveness.
[18] Environmental monitoring
[19] Reanalysis.
[20] Requirements: preventive controls qualified individual (PCQI) / qualified auditor.
[21] Implementation records required for this Plan.

CA PROP 65
TIME HAS RUN 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 a few days 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/
My experience will strengthen your company!  I provide private and confidential, competent electronic professional consulting to my Dietary Supplement and advanced healthcare ("CAM") modality clients, for the purpose of compliance with International, State and Federal (including FTC and FDA) standards for communicating about the advertising and sale of dietary supplements (including medical foods) and/or providing of health care services and information. You should consider my SOP / cGMP Certification Course, allowing start-up and established vitamin companies and practitioners who own their own private labeled products to meet with new FDA procedural regulations.
Here is a summary of the FDA's web page on the types of claims that can be made for foods and supplements.

https://www.fda.gov/food/labelingnutrition/ucm111447.htm

Among the common claims that can be used on food ("Nutrition Facts") and dietary supplement ("Supplement Facts") labels are three categories of claims that are defined by statute and/or FDA regulations:

Health Claims
Nutrient Content Claims
Structure/Function Claims

As I've said many times... beneficial formulas are "easy."  Lawful and powerful claims are not. Without being able to persuasively explain the benefit, even the best formula will not sell.

Health Claims

"Health Claims" describe a relationship between a food substance (a food, food component, or dietary supplement ingredient), and reduced risk of a disease or health-related condition.  They require prior FDA approval.

Nutrient Content Claims

"The Nutrition Labeling and Education Act of 1990 (NLEA) permits the use of label claims that characterize the level of a nutrient in a food (i.e., nutrient content claims) if they have been authorized by FDA and are made in accordance with FDA's authorizing regulations."

Structure/Function Claims and Related Dietary Supplement Claims

"The Dietary Supplement Health and Education Act of 1994 (DSHEA) established some special regulatory requirements and procedures for using structure/function claims and two related types of dietary supplement labeling claims, claims of general well-being and claims related to a nutrient deficiency disease.'

When you need to find your way through the bureaucratic maze that is claim-making, remember the Vitamin Consultancy... we are here to help! 

New FDA Guidance

Friday, July 6, 2018

Categories of DSHEA Claims - July 2018 Newsletter

NEW RULES IN EFFECT AUGUST!

www.ProfessionalSafetyDossier.com
Call Me! 973-300-4594 No Time to Delay!
----------------------------------------------------
Categories of DSHEA Claims

While you are thinking about August's Proposition 65 Deadline, here is a summary of the FDA's web page on the types of claims that can be made for foods and supplements. [1]

Among the common claims that can be used on food ("Nutrition Facts") and dietary supplement ("Supplement Facts") labels are three categories of claims that are defined by statute and/or FDA regulations:

          Health Claims
          Nutrient Content Claims
          Structure/Function Claims


As I've said many times... beneficial formulas are "easy."  Lawful and powerful claims are not. Without being able to persuasively explain the benefit, even the best formula will not sell.

Health Claims

"Health Claims" describe a relationship between a food substance (a food, food component, or dietary supplement ingredient), and reduced risk of a disease or health-related condition.  They require prior FDA approval.

Ther are 3 ways a health claim may be used on a label or in labeling (the sales information that makes up the "extended label" according to FDA) for a conventional food or dietary supplement:

1) the 1990 Nutrition Labeling and Education Act (NLEA) allows FDA to regulate  health claims for foods and dietary supplements after reviewing and evaluating the scientific evidence, either in response to a health claim petition or on its own initiative (the Neuro Food Defect Claim is an example);

2) the 1997 Food and Drug Administration Modernization Act (FDAMA) provides for health claims based on an authoritative statement of the National Academy of Sciences or a scientific body of the U.S. government with responsibility for public health protection or nutrition research -- FDA has 120 days after application to allow or not; can be used during application period;

3) as described in FDA’s guidance entitled Interim Procedures for Qualified Health Claims in the Labeling of Conventional Human Food and Human Dietary Supplements (Pearson v Shalala Claims), the agency reviews petitions for qualified health claims where the quality and strength of the scientific evidence falls below that required for FDA to issue an authorizing regulation. If FDA finds that the evidence supporting the proposed claim is credible and the claim can be qualified to prevent it from misleading consumers, the agency issues a letter of enforcement discretion specifying the qualifying language that should accompany the claim and describing the circumstances under which it intends to exercise enforcement discretion for use of the claim in food labeling. There are about two dozen approved Qualified Claims. The Vitamin Consultancy offers a Health Claims Webinar describing each.  http://www.vitaminconsultancy.com/webinars.php

Nutrient Content Claims

"The Nutrition Labeling and Education Act of 1990 (NLEA) permits the use of label claims that characterize the level of a nutrient in a food (i.e., nutrient content claims) if they have been authorized by FDA and are made in accordance with FDA's authorizing regulations. Nutrient content claims describe the level of a nutrient in the product, using terms such as free, high, and low, or they compare the level of a nutrient in a food to that of another food, using terms such as more, reduced, and lite. An accurate quantitative statement (e.g., 200 mg of sodium) that does not otherwise "characterize" the nutrient level may be used to describe the amount of a nutrient present. However, a statement such as "only 200 mg of sodium" characterizes the level of sodium by implying that it is low. Therefore, the food would have to meet the nutritional criteria for a “low” nutrient content claim or carry a disclosure statement that it does not qualify for the claim (e.g., “not a low sodium food”). Most nutrient content claim regulations apply only to those nutrients that have an established Daily Value... Healthy is an implied nutrient content claim that characterizes a food as having "healthy" levels of total fat, saturated fat, cholesterol and sodium, as defined in the regulation authorizing use of the claim. Percentage claims for dietary supplements are another category of nutrient content claims. These claims are used to describe the percentage level of a dietary ingredient in a dietary supplement and may refer to dietary ingredients for which there is no established Daily Value, provided that the claim is accompanied by a statement of the amount of the dietary ingredient per serving. Examples include simple percentage statements such as "40% omega-3 fatty acids, 10 mg per capsule," and comparative percentage claims, e.g., "twice the omega-3 fatty acids per capsule (80 mg) as in 100 mg of menhaden oil (40 mg)." ..."

Structure/Function Claims and Related Dietary Supplement Claims

"The Dietary Supplement Health and Education Act of 1994 (DSHEA) established some special regulatory requirements and procedures for using structure/function claims and two related types of dietary supplement labeling claims, claims of general well-being and claims related to a nutrient deficiency disease. Structure/function claims may describe the role of a nutrient or dietary ingredient intended to affect the normal structure or function of the human body, for example, "calcium builds strong bones." In addition, they may characterize the means by which a nutrient or dietary ingredient acts to maintain such structure or function, for example, "fiber maintains bowel regularity," or "antioxidants maintain cell integrity." General well-being claims describe general well-being from consumption of a nutrient or dietary ingredient. Nutrient deficiency disease claims describe a benefit related to a nutrient deficiency disease (like vitamin C and scurvy), but such claims are allowed only if they also say how widespread the disease is in the United States. These three types of claims are not pre-approved by FDA, but the manufacturer must have substantiation that the claim is truthful and not misleading and must submit a notification with the text of the claim to FDA no later than 30 days after marketing the dietary supplement with the claim. If a dietary supplement label includes such a claim, it must state in a "disclaimer" that FDA has not evaluated the claim. The disclaimer must also state that the dietary supplement product is not intended to "diagnose, treat, cure or prevent any disease," because only a drug can legally make such a claim."

When you need to find your way through the bureaucratic maze that is claim-making, remember the Vitamin Consultancy... we are here to help! 


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[1] https://www.fda.gov/food/labelingnutrition/ucm111447.htm