Sunday, January 15, 2017

FDA Mobile App Regulations



This memorandum covers developing FDA regulations of Mobile Apps. To a great extent, the future of internet communication is via Apps. Some estimate that 80% of internet traffic will be Mobile App mediated by the end of the decade.

Bottom Line: The time to enter the Mobile App space may be now…

Here is an example of a Mobile App (for Dr. Rima Laibow) described here: http://tinyurl.com/HealthFreedomApp.

FDA Regs on Mobile Apps

Some of the questions being considered by the regulators:

-         How the FDA should categorize mobile apps and decides how, or whether, to regulate them as medical devices.
-         How the FDA evaluates an app's "intended use."
-         How to interpret the FDA's promise of "enforcement discretion" for certain types of apps.
-         Who can be considered a mobile medical app developer and what regulations affect them.

FDA's evolving stance on Mobile Apps sorts them into three categories:

-         Administrative health information technology (e.g, billing, claims processing, general communication and scheduling): This is not a medical device and not regulated by the agency.

-         Health management information technology (e.g., medication management, data capture, electronic access to clinical results, provider order entry): This is under FDA jurisdiction but generally so low risk that the agency can exercise enforcement discretion and not apply regulations.

-         Medical device health information technology (e.g., computer-aided detection and diagnosis, robotic surgical planning, remote display of bedside alarms, radiation treatment planning): This is actively regulated under Class I, Class II and Class III medical device rules.

Here is what the FDA is saying about Mobile Apps:

The widespread adoption and use of mobile technologies is opening new and innovative ways to improve health and health care delivery.

Mobile applications (apps) can help people manage their own health and wellness, promote healthy living, and gain access to useful information when and where they need it. These tools are being adopted almost as quickly as they can be developed. According to industry estimates, 500 million smartphone users worldwide will be using a health care application by 2015, and by 2018, 50 percent of the more than 3.4 billion smartphone and tablet users will have downloaded mobile health applications (http://www.research2guidance.com/500m-people-will -be-using-healthcare-mobile-applications-in-2015/). These users include health care professionals, consumers, and patients.

The FDA encourages the development of mobile medical apps that improve health care and provide consumers and health care professionals with valuable health information. The FDA also has a public health responsibility to oversee the safety and effectiveness of medical devices – including mobile medical apps.

The FDA issued the Mobile Medical Applications Guidance for Industry and Food and Drug Administration Staff (PDF - 269KB) on September 25, 2013, which explains the agency’s oversight of mobile medical apps as devices and our focus only on the apps that present a greater risk to patients if they don’t work as intended and on apps that cause smartphones or other mobile platforms to impact the functionality or performance of traditional medical devices.

What are mobile medical apps?

Mobile apps are software programs that run on smartphones and other mobile communication devices. They can also be accessories that attach to a smartphone or other mobile communication devices, or a combination of accessories and software.
Mobile medical apps are medical devices that are mobile apps, meet the definition of a medical device and are an accessory to a regulated medical device or transform a mobile platform into a regulated medical device.

Consumers can use both mobile medical apps and mobile apps to manage their own health and wellness, such as to monitor their caloric intake for healthy weight maintenance. For example, the National Institutes of Health’s LactMed app provides nursing mothers with information about the effects of medicines on breast milk and nursing infants.

Other apps aim to help health care professionals improve and facilitate patient care. The Radiation Emergency Medical Management (REMM) app gives health care providers guidance on diagnosing and treating radiation injuries. Some mobile medical apps can diagnose cancer or heart rhythm abnormalities, or function as the “central command” for a glucose meter used by an insulin-dependent diabetic patient.

How will the FDA regulate mobile medical apps?

The FDA will apply the same risk-based approach the agency uses to assure safety and effectiveness for other medical devices.  The guidance document (PDF - 269KB) provides examples of how the FDA might regulate certain moderate-risk (Class II) and high-risk (Class III) mobile medical apps. The guidance also provides examples of mobile apps that are not medical devices, mobile apps that the FDA intends to exercise enforcement discretion and mobile medical apps that the FDA will regulate in Appendix A, Appendix B and Appendix C.
We encourage app developers to contact the FDA – as early as possible – if they have any questions about their mobile app, its level of risk, and whether a premarket application is required.

Mobile medical apps that the FDA will regulate

The FDA is taking a tailored, risk-based approach that focuses on the small subset of mobile apps that meet the regulatory definition of “device” and that:

-         Are intended to be used as an accessory to a regulated medical device, or
-         Transform a mobile platform into a regulated medical device.

Mobile apps span a wide range of health functions. While many mobile apps carry minimal risk, those that can pose a greater risk to patients will require FDA review.

For a list of what is considered a mobile medical application, manufacturers and developers of mobile applications can search FDA’s database of existing classification by type of mobile medical application  (for example diagnostic).  Approved/cleared mobile medical applications will also be listed in FDA’s 510(k) and PMA databases and on the FDA’s Registration & Listing Database.

FDA’s mobile medical apps policy does not require mobile medical app developers to seek Agency re-evaluation for minor, iterative product changes.

Mobile apps for which the FDA intends to exercise enforcement discretion

For many mobile apps that meet the regulatory definition of a “device” but pose minimal risk to patients and consumers, the FDA will exercise enforcement discretions and will not expect manufacturers to submit premarket review applications or to register and list their apps with the FDA. This includes mobile medical apps that:

-         Help patients/users self-manage their disease or condition without providing specific treatment suggestions;
-         Provide patients with simple tools to organize and track their health information;
-         Provide easy access to information related to health conditions or treatments;
-         Help patients document, show or communicate potential medical conditions to health care providers;
-         Automate simple tasks for health care providers; or
-         Enable patients or providers to interact with Personal Health Records (PHR) or Electronic Health Record (EHR) systems.

Does the FDA regulate mobile devices and mobile app stores?

FDA’s mobile medical apps policy does not regulate the sale or general consumer use of smartphones or tablets. FDA’s mobile medical apps policy does not consider entities that exclusively distribute mobile apps, such as the owners and operators of the “iTunes App store” or the “Google Play store,” to be medical device manufacturers. FDA’s mobile medical apps policy does not consider mobile platform manufacturers to be medical device manufacturers just because their mobile platform could be used to run a mobile medical app regulated by FDA.

Does the guidance apply to electronic health records?


FDA’s mobile medical app policy does not apply to mobile apps that function as an electronic health record (EHR) system or personal health record system.

House Passes HR5 to Redress Judicial "Deference"

Judicial Oversight of Federal Regulatory Bureaucrats
House Passes HR5 to Redress Judicial "Deference" To Agencies' Interpretation of Law - When Will Senate Send Bill to New President?

Regulatory Accountability Act of 2017 [1]
https://congress.gov/bill/115th-congress/house-bill/5/
https://www.congress.gov/bill/115th-congress/house-bill/5/text


In a package of regulatory reforms just passed by the Federal House of Representatives, one stands out to me: legislative reversal of what is called "Chevron Deference" -- the deference Federal Judges were supposed to give to Federal Agencies when the bureaucrats "interpreted the law..." where the congressional statute is "ambiguous," thereby making it very difficult to have standing to sue to challenge regulatory restrictions. 

Now, however, judges will have to make a positive legal determination and not just rely on Agency positions as to the meaning of the law.

Here is how Wikipedia describes the Chevron case.

"Chevron U.S.A., Inc. v. Natural Resources Defense Council, Inc., 467 U.S. 837 (1984), was a landmark case in which the United States Supreme Court set forth the legal test for determining whether to grant deference to a government agency's interpretation of a statute which it administers. Chevron is the Court's clearest articulation of the doctrine of "administrative deference," to the point that the Court itself has used the phrase "Chevron deference" in more recent cases." [2]

Under HR5 Congress tells judges that Federal Agencies cannot rely on their own interpretations of the law, but must now defer to the judges, who may consider, but are not bound by, agency positions on the meaning of even ambiguous statutes.  This is especially powerful with regard to FDA overreaching -- for example, when they try to ignore the Dietary Supplement Protection provision in the 2010 "Food Safety [sic] Modernization Act" by their restrictive interpretation of what is a "grandfathered" ingredient under DSHEA, the Dietary Health and Education Act of 1994.

Federal judges, often in dissent, have expressed misgivings about Chevron Deference. Circuit Judge Gorsuch, defending the rule of law, expressed it this way last August:

"There’s an elephant in the room with us today. We have studiously attempted to work our way around it and even left it unremarked. But the fact is Chevron and Brand X permit executive bureaucracies to swallow huge amounts of core judicial and legislative power and concentrate federal power in a way that seems more than a little difficult to square with the Constitution of the framers’ design. Maybe the time has come to face the behemoth." [3]

As is often the case in Federal statutory changes, where one is dealing with very complex provisions, one must be careful to find the operative language. It appears the actual statutory language that accomplishes the reversal of Chevron Deference is here:

"Agency guidance... is not legally binding and may not be relied upon by an agency as legal grounds for agency action..." Bill Section 104.

Other provisions of the Bill as adopted by the House change some of the steps in the Administrative Procedures Act structure for the establishment of new Federal Regulations, making more effective the right of "stake holders" to challenge proposed regulations in Court.

The Republican Party maintained control of Congress with the promise that the party would sponsor a roll-back of the regulatory state. The party's successful presidential candidate made this one of his primary promises. The House has acted; now the Senate must consider how to further redress the imbalance between business and the bureaucracy, sending the matter to the new president for rapid final approval.

With HR5 and its several provisions changing the way in which Regulations are developed and adopted, significant changes in the balance between entrapreneurs and bureaucrats may be taking place.

The possibility is certainly worth watching...


Ralph Fucetola JD

You can reach me by phone: 973.300.4594
By email: ralph.fucetola@gmail.com
By Skype: vitaminlawyer

Are Your Papers in Order?
SOPs and GMPs My Specialty
www.SOPcertification.com
www.VitaminConsultancy.com

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

[1] "The Regulatory Accountability Act of 2017, which passed 238-183 Wednesday evening, rolled together a series of previously passed bills to repeal the Chevron deference standard and require mandatory litigation stays for new rules, among other reforms. "

https://www.law360.com/publicpolicy/articles/879235/house-passes-bill-ending-chevron-deference?nl_pk=9625454e-8a7f-4722-b1cd-d5f9ee160756&utm_source=newsletter&utm_medium=email&utm_campaign=publicpolicy

[2] https://en.wikipedia.org/wiki/Chevron_U.S.A.,_Inc._v._Natural_Resources_Defense_Council,_Inc.

[3] These excerpts from Judge Gorsuch's concurring opinion in a 2016 Tenth Circuit immigration case discuss the way Chevron Deference works, or rather, doesn't work, in actual judicial practice, calling upon Congress to act to change the case law. Congress is doing just that.

"No. 14-9585, Gutierrez-Brizuela v. Lynch
GORSUCH, Circuit Judge, concurring.

There’s an elephant in the room with us today. We have studiously attempted to work our way around it and even left it unremarked. But the fact is Chevron and Brand X permit executive bureaucracies to swallow huge amounts of core judicial and legislative power and concentrate federal power in a way that seems more than a little difficult to square with the Constitution of the framers’ design. Maybe the time has come to face the behemoth.

In enlightenment theory and hard won experience under a tyrannical king the founders found proof of the wisdom of a government of separated powers. In the avowedly political legislature, the framers endowed the people’s representatives with the authority to prescribe new rules of general applicability prospectively. In the executive, they placed the task of ensuring the legislature’s rules are faithfully executed in the hands of a single person also responsive to the people. And in the judiciary, they charged individuals insulated from political pressures with the job of interpreting the law and applying it retroactively to resolve past disputes. This allocation of different sorts of power to different sorts of decision makers was no accident...

Even more importantly, the founders considered the separation of powers a vital guard against governmental encroachment on the people’s liberties, including all those later enumerated in the Bill of Rights...

When the political branches disagree with a judicial interpretation of existing law, the Constitution prescribes the appropriate remedial process. It’s called legislation. Admittedly, the legislative process can be an arduous one. But that’s no bug in the constitutional design: it is the very point of the design...

But acknowledging this much only brings the colossus now fully into view. In the Administrative Procedure Act (APA), Congress vested the courts with the power to “interpret . . . statutory provisions” and overturn agency action inconsistent with those interpretations. 5 U.S.C. § 706. Congress assigned the courts much the same job in the immigration field where we happen to find ourselves today. 8 U.S.C. § 1252(a)(2)(D). And there’s good reason to think that legislative assignments like these are often constitutionally compelled. After all, the question whether Congress has or hasn’t vested a private legal right in an individual “is, in its nature, judicial, and must be tried by the judicial authority.” Marbury v. Madison, 5 U.S. (1 Cranch) 137, 167 (1803)...

All of which raises this question: what would happen in a world without Chevron? If this goliath of modern administrative law were to fall? Surely Congress could and would continue to pass statutes for executive agencies to enforce. And just as surely agencies could and would continue to offer guidance on how they intend to enforce those statutes. The only difference would be that courts would then fulfill their duty to exercise their independent judgment about what the law is. Of course, courts could and would consult agency views and apply the agency’s interpretation when it accords with the best reading of a statute. But de novo judicial review of the law’s meaning would limit the ability of an agency to alter and amend existing law. It would avoid the due process and equal protection problems of the kind documented in our decisions...."

Saturday, December 31, 2016

2017 Health Freedom Assessment

Inspired by General Bert
Here is Our 2017
Health Freedom Assessment
Urgent Information for Your Future


I visited my friends and fellow trustees, Dr. Laibow and Gen. Stubblebine (at JFK Hospital, Edison, NJ) where Gen. Bert has been for the last 120 days a couple days ago.  Gen. Bert is improving and we had a chance to catch up about the election and other strategic health freedom-related issues. His take? 2016 was not a good year for health freedom. Except for our amazing court victory the week before Christmas in which a Judge of the NJ Superior Court confirmed once again the right of Informed Consent, even in hospitals! Bert lives. Nutritional therapy works, when hospitals allow it.

You can read the Assessment here:

http://drrimatruthreports.com/the-generals-2017-assessment/

Or watch the video version here:

https://youtu.be/dNIg67mjayY

Please share these links widely on social media.

May you and your have a prosperous, healthy and free new year

Monday, December 12, 2016

The Vitamin Importer's “Ace in the Hole”

The Vitamin Importer's “Ace in the Hole”
Automated Commercial Environment (ACE)
Import Data System

This Vitamin Consultancy Newsletter focuses on an important aspect of business for the natural nutrient products market -- using the new ACE system to comply with requirements for importing FDA regulated products.

The new system will make it easier for FDA to block what it considers contraband, but it will also largely take the risk out of importing: you should know in advance whether your shipment would be stopped if shipped, thereby avoiding the expenses of rejected and returned shipments.

What follows are excerpts from the FDA announcement of its new imported products data requirements * that must be met at the point of entry.  Use of the ACE - Automated Commercial Environment - data system will be required as of December 29, 2016. This applies to all FDA regulated products imported into the United States.

The regulation does not distinguish between Foods and Dietary Supplements, treating DSs as Foods.

Whenever you intend to import a food product, you are required to notify the FDA.

Key regulation points:

1. "The owner or consignee of an FDA-regulated product is now defined as the importer of record."
2. "FDA can reject an entry for failure to provide through ACE the complete and accurate information required by the rule..."
3. "FDA will continue to provide assistance to filers working to properly submit the required data."
4. Intended Use Code (IUC) ** required for ACE submittal.

Practice Guide: Use the email and phone contacts below to make successful import filings.  FDA will walk you through your first use of ACE.

Ralph Fucetola JD

Source: http://blogs.fda.gov/fdavoice/index.php/2016/11/trade-alert-fda-issues-new-import-data-requirements/?source=govdelivery&utm_medium=email&utm_source=govdelivery

From: Trade Alert: FDA Issues New Import Data Requirements
Posted on November 30, 2016 by FDA Voice by: Howard Sklamberg, J.D. (Deputy Commissioner for Global Regulatory Operations and Policy)

"One of FDA’s many responsibilities is to review imported products regulated by the agency to determine admissibility. This job has become increasingly challenging with growing volumes of imports of FDA-regulated products each year — from six million import entries in 2002 to 35 million in 2015."

"...A final rule published on November 29 in the Federal Register specifies certain data that must be submitted in ACE when an FDA-regulated product is offered for import into the United States..."

"The rule also includes technical revisions to certain sections of FDA regulations:

    "The owner or consignee of an FDA-regulated product is now defined as the importer of record. This brings FDA regulations up to date with previous revisions to customs laws. (21 CFR 1.83 and 21 CFR 1005.2)

    FDA will now directly provide a notice that an FDA-regulated product is to be sampled, rather than having to go through CBP to provide that notice. (21 CFR 1.90)

    FDA may now provide written notices electronically to the importer of record about FDA actions to refuse FDA-regulated products and/or subject certain drug products to administrative destruction. (21 CFR 1.94)

    The rule clarifies that FDA can reject an entry for failure to provide through ACE the complete and accurate information required by the rule."

----- Important Resources -----

"FDA will continue to provide assistance to filers working to properly submit the required data.

Some of the measures we have instituted:
 
  •     We are offering telephone meetings with importers, customs brokers, and other stakeholders, in real-time, while they are filing entries in ACE. Request a meeting by emailing ACE_Support@fda.hhs.gov.
  •     An ACE Support Center is staffed 24/7. Reach FDA staff by email at ACE_Support@fda.hhs.gov or by phone at a domestic toll-free line (877-345-1101) or a local/international line (571-620-7320).
  •     Upon request, FDA will assist in a filer’s first ACE submission, or for filers who import various commodities, FDA will assist with every first submission of a particular commodity.
  •     Additional assistance for general import operations and policy questions, including FDA product codes and entry requirements, is available via email at FDAImportsInquiry@fda.hhs.gov or by calling 301-796-0356."

There are various other requirements that may delay importation, or add costs to it, *** but food importation notices through ACE have the potential to simplify importation red tape.
-------------------------------------------
* The Data Requirements are set forth in the Federal Register: https://www.federalregister.gov/documents/2016/11/29/2016-28582/submission-of-food-and-drug-administration-import-data-in-the-automated-commercial-environment

** Intended Use Codes (IUC): https://www.cbp.gov/document/guidance/appendix-r-intended-use-codes-ace  --

"Base Code 230.000 - For Consumer Use as Human Food - A human food product intended for distribution in the general public supply chain or military commissaries in its present form with or without repackaging or with minimal processing such as cooking, slicing, or peeling. Examples include packaged food products, pre-packed salads, fresh chopped or cut vegetables and fruits, bulk fruits for consumer packaging, and convenience foods." [Dietary Supplements, as "packaged food products..." are included in Base Code 230.00.]

*** The General Enforcement regulations are at: https://www.gpo.gov/fdsys/pkg/CFR-2016-title21-vol1/xml/CFR-2016-title21-vol1-part1.xml  - Subpart E relates to imports and exports.
05 December 2016

Monday, November 21, 2016

Food Safety Summary for DSHEA Products

Food Safety Summary for DSHEA Products

Company Action Alert:  Biennial Food Facility Registrations Due Dec 2016

This memorandum is paraphrased from a number of sources and is intended as a private communication to the regular clients of The Vitamin Consultancy.

Introduction

The Food Safety Modernization Act was signed in 2011 (with some protection for DSHEA products that I fought hard to have included) and with it, notably tougher government and retailer food safety standards.

Demands on companies to demonstrate regulatory compliance and due diligence will continue to escalate, yet just one failed performance verification audit or one product recall can significantly damage your business -- even if you have written Standard Operating Procedures in place.

In these litigious times, lawyers and consumers alike will seize on any opportunity to take legal action against manufacturers in the event of finding any issue with the product purchased. Food manufacturers supplying retail organizations understand the need to ensure the highest product quality.

It is therefore in the best interests of manufacturers marketers to take steps to ensure systems and procedures are in place to minimize the risk of harm to the public and consequent litigation. In the event of such an instance, the company must have the necessary documentary evidence that the company has been duly diligent in the manufacturing process.

The FDA states that the Label Owner for the product is ultimately responsible for assuring that the ingredient providers, manufacturers, packers, shippers and all persons involved in the process adhere to all food safety regulations.

The Primary Food Safety Regulations include:

[1] The Food Facility RegistrationBiennial renewals are due Oct – Dec 2016 (and 2018, 2020, etc) -- http://www.fda.gov/Food/GuidanceRegulation/FoodFacilityRegistration/default.htm

[Practice Note: you must confirm the registration receipt email by return email within 30 days or the registration is not valid.]

[2] Good Manufacturing Processes (GMPs) which vary depending on whether the product is an OTC drug, a cosmetic, or a food or dietary supplement (by the way, in DSHEA, the Dietary Supplement Health and Education Act of 1994, Congress directed FDA to model the Dietary Supplement GMPs after Food GMPs, not Drug GMPs.

[3] The 2011 Food Safety Law which gave enhanced powers to FDA, but, in section 1011 of the Act preserved our grandfathered DSHEA ingredients from those enhanced powers.

[Practice Note: this means the battle has shifted to exactly what ingredients are “grandfathered.”]

Additionally there are local (city, county) and state regulations that apply to the handling of foods.

Some of the overall concerns that arise are included in the following “Black Letter Law” overview:

Duty of Care

Under the common law we each have a Duty of Care which requires that we conform to a standard of reasonable care regarding any acts or omissions that could foreseeably harm others. The Standard of Care is the standard degree of watchfulness, attentiveness, prudence and caution of a reasonable individual who is under a Duty of Care.

In manufacturing the Standard of Care is determined by the cGMPs as implemented by a reasonably prudent manufacturer of a product.

Failure to meet the Standard of Care will likely be regarded as negligence, and any proximately caused, foreseeable damages may be claimed by an injured party.

Due Diligence

That the company engaged in Due Diligence to determine the Duty and Standard of Care can be a defense for to manufacturers accused of violating food safety regulations (but, of course, the regulations have to be implemented going forward). This defense asserts that the accused took all reasonable practicable steps to avoid the harm. It is a sufficient defense for the person charged to prove that:

• All reasonable precautions were taken, with
• All due diligence to avoid the occurrence, whether personally or through any person under their control.

“Taking all reasonable precautions” includes setting up systems of control which are appropriate to the risk. What is reasonable is determined by the size and resources of the business. “Exercising all due diligence” involves having procedures in place which review and audit the system to ensure it is operating effectively.

Whether or not a defense will be successful depends on the circumstances surrounding each case.

Hazards Analysis Critical Control Points

In food production cGMPs call for a Hazards Analysis Critical Control Points (HACCP) based system to support the procedures to identify where hazards might occur. The HACCP structure is then used to put into place procedures to mitigate the risk of the hazard from occurring in the first place. The HACCP process strictly monitors and controls each manufacturing step, to reduce the probability for hazards to occur.  This is similar to the section in my standard SOPs on CAPA (Section 20).

HACCP is based on 7 core principles:

• Conduct a food safety hazard analysis
• Identify the Critical Control Points (CCPs) (point at which a hazard is optimally controlled)
• Establish critical limits for each CCP
• Establish CCP monitoring requirements
• Establish corrective actions when monitoring indicates that a particular CCP is not under control
• Establish record keeping procedures
• Establish procedures to verify system is working as intended

Summary

We have briefly looked at the Black Letter law concepts of Duty and Standard of Care, and Due Diligence and have listed the three primary areas of FDA food safety control.

Having Standard Operating Procedures (SOPs) that track the appropriate GMPs for the type of regulated product manufacturing is an important first step in meeting regulatory requirements.

The second step is to fully implementing them.

However, even if “all your papers are in order” your ingredients or claims may run afoul of FDA food safety regulatory actions. Only close attention to changes in the enforcement climate will keep you ahead of the pack of competitors.

The Vitamin Consultancy aims to keep you informed so you can continue to develop and market your dietary supplement products in relative freedom.

rf...

Thursday, October 27, 2016

Agenda 2020 - Foresight, Not Hindsight

THE VITAMIN CONSULTANCY NEWSLETTER
Agenda 2020 - Foresight, Not Hindsight

Re: The Institute for Health Research and the Vitamin Consultancy's Business Collaborative

The natural product industry in the United States has been growing rapidly for the past half century.  As a participant in that business, you want to know where it is going next. The next big thing? The next regulatory assault? You need foresight, not hindsight. That's what this private memo is about.

To paraphrase, "An industry divided will not stand."  I have been closely observing the direction the government is taking with regard to supplements and I don't like it! Back in the '70s and '80s there were far fewer supplement companies, and they were small by today's standards. But those that existed pulled together, understanding that there was safety in numbers, and by the mid-'90s we were able to cajole Congress into giving DSHEA (the Dietary Supplement Health and Education Act) unanimous approval.

The industry that grew from that push back is now maturing and its participants need to pay attention to the threats, and opportunities, on the horizon.

Since you are on my Vitamin Consultancy email list you probably know that I practiced law for 36 years, becoming known as The Vitamin Lawyer. Today I continue my work through my Vitamin Consultancy and as Vice President of Natural Solutions and President of the Institute for Health Research -- www.InHeRe.org

A plan is developing for the next few years that involves you and your company. The plan is called Agenda 2020 as it is envisioned to be fully implemented over the next four years -- our "20-20" vision for the future.

The plan includes continued enhancements to the Vitamin Consultancy, bringing additional professionals into the Consultancy. An example is the Cosmetic Dossier Service Dr. R. Goodman and I provide.

Our core VC services will continue to be upgraded:

1. Label, literature and claims consulting
2. General vitamin industry consulting
3. SOP and GMP compliance
4. The Cosmetic Dossier
5. The Vitamin Consultancy Webinar Training System
6. GMP physical and virtual audits

These services are funded through client fees and are self-supporting.

But that is not all that we do here. Natural Solutions Foundation and the Institute for Health Research have a significant portion of my attention, my time and advise. Their activities need to be self-supporting too. This memo focuses on the Institute.

But be aware there are some exciting changes coming to Natural Solutions -- to be covered in a future memo.

The Institute for Health Research was established in 1998 by Green Turtle Bay Vitamins founder Karen Horbatt and Dr. Richard Podell, a well-known Jersey physician and teacher. I am the third trustee. Today Ms Horbatt remains our Chairwoman Emeritus, I am President of the Institute and several health professionals, including Rima Laibow MD have joined the Board.

We have begun to publish a professional Journal and seek leading-edge health, natural approach research papers. Our focus is providing actionable information for people in the natural products arena. You can read the first published articles, by luminaries such as Gary Null, ND, Sharry Edwards, MEd and Rima Laibow, MD, at www.InHeRe.org

US tax law allows your company to donate up to 5% of its gross profits to charitable activities, and gain a significant tax break. The Institute is authorized to accept such donations and issue the appropriate tax receipt. We have a PayPal donation button on the main page and are also happy to receive checks or money orders made out to the Institute c/o Ralph Fucetola, 58 Plotts Rd, Newton, NJ 07860.

How much of your company's gross profits are you ready to allocate toward protecting your Commercial Health Freedom? This is the time of year when it is prudent to make those allocations.

Here is the monthly Institute budget I need your help to meet:

1. Office space, overhead and supplies: $1500
2. Web Master / Site & Journal Maintenance: $1,000
3. EList maintenance: $700
4. Educate Decision Makers system: $700
5. Social Media Intern: $750

There are other expenses. For example, we need to develop a PR budget, including adequate funds for at least quarterly trips to venues such as Washington, DC or trade meetings.
 
Bottom line: what can funding the Institute office do for you?

The Vitamin Consultancy will be able to continue to provide you with a very high level of professional consulting for modest hourly fees, along with the Webinar System and other special services.

But, as the Institute becomes properly funded, in cooperation with the Consultancy, I will also be able to provide Sustaining Members early alerts critical to operating in an increasingly complex regulatory climate.

The first Alert from the Institute that I am preparing is a Special Report: Food Safety Regulation -- Action List. These will include summaries of the private alerts I provide  privately to my Monthly Retainer Consultancy Clients. Biannual registration renewals are due.

Another powerful business's tool we are developing is the Nutrient Companies' Business Collaborative -- a private information exchange that brings best practices to the fore, keeping the Sustaining Members at the leading edge.

The goal of the Collaborative is to introduce its members to each other, to share their special capacities for mutual benefit, and clout. "Push Back Works" and pushing back together works even better.

As a Sustaining Member your company will be among the first to hear about new technologies and leading edge approaches, such as using frequency in the testing and processing of food products. Here I am thinking of the pioneering frequency matrix work of Sharry Edwards or the recent frequency analysis article by Mike Adams.

How does your company become a Sustaining Member?

Set up a recurring donation through our PayPal donation button at www.InHeRe.org or send a check or money order for one year (min. $1200). We will provide appropriate tax receipts. If it is convenient for you, I can arrange to have the Institute send you a monthly invoice from its PayPal account.

Whether a clear vision for Agenda 2020 comes into sight will depend on you seeing that vision benefiting the future success of your business. IMHO, it's time foresee where we are going.

Call me if you have any questions, or just to let me know that you are in...

Ralph Fucetola JD
973.300.4594                         

Tuesday, October 18, 2016

Merchant Accounts for Nutrients

Merchant Account for Nutrients


One of the challenges facing dietary supplement companies is where to find merchant services, such as the ability to accept credit and debit cards for your product sales.  For leading-edge products this can be quite a challenge. For example, PayPal is well-known for cutting-off companies that sell products such as CBDs and the like.

Dan Fucetola of Winning Business Solutions has sourced a merchant account company that specializes in nutrient products.

You can find out more here:

www.winning-business-solutions.com

Just click on "G.E.T. Merchant Account: START HERE."

"We are proud to partner with Global Electronic Technology, Inc. for Merchant Services. Yes, they do handle dietary supplement products and anything else you can sell. Start by sending us a message to the special contact form below. Our GET account manager Luis will contact you directly. Please include your phone and email."
 
Regards,

Ralph ...
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.