Congress Sneaks Another Bone to Big Pharma!

 New Peptide Rules

Congress subtly changed the definition of a 'biological product' to give Big Pharma control of the sale of proteins to treat disease. As usual such maneuvers leave loopholes within the loopholes...

"The FDA had previously stated its interpretation of the statutory terms “protein” and “chemically synthesized polypeptide” in the amended statutory definition of “biological product.” The FDA interprets the term “protein” to mean any alpha amino acid polymer with a specific defined sequence that is greater than 40 amino acids in size. Alternatively, the FDA previously interpreted the term “chemically synthesized polypeptide” to mean any alpha amino acid polymer that is made entirely by chemical synthesis and is greater than 40 amino acids, but less than 100 amino acids in size.

A “chemically synthesized polypeptide” was not a “biological product” and was not going to be regulated as a drug under the FD&C Act unless the polypeptide otherwise met the statutory definition of a “biological product.” This definition was scientifically appropriate, but at the last minute, the latest appropriations bill (enacted in December of 2019) further amended the definition of “biological product” to remove “(except any chemically synthesized polypeptide).” Now, in the definition ... there is no differentiation between protein and polypeptide." [1]

The new definition is:

"Biological Product – A virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, protein, or analogous product, or arsphenamine or derivative of arsphenamine (or any other trivalent organic arsenic compound), applicable to the prevention, treatment, or cure of a disease or condition of human beings." [2]

Note that the parenthetical “(except any chemically synthesized polypeptide)” has been removed.

FDA further states:

"Under this final rule, the term protein means any alpha amino acid polymer with a specific, defined sequence that is greater than 40 amino acids in size. This final rule is intended to clarify the statutory framework under which such products are regulated." [3]

Under the new definition, as interpreted by FDA, any "protein" 40 or less amino acids is still available as a "food" product. Any naturally occurring protein that is not chemically changed appears to still qualify as a food and thus as a Medical Food. Doctors may recommend Medical Foods for the dietary management of health conditions.

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[1] https://bengreenfieldlife.com/article/supplements-articles/peptides-fda/

[2] "This final rule codifies the Food and Drug Administration’s (FDA or Agency) interpretation of the statutory term “protein” that the Agency previously described in guidance (Ref. 1). This final rule does not finalize the FDA’s interpretation of “chemically synthesized polypeptide” because section 605 of the Further Consolidated Appropriations Act, 2020 (Public Law 116-94) (FCA Act) removed the parenthetical “(except any chemically synthesized polypeptide)” from the category of “protein” in the definition of “biological product” in section 351(i) of the Public Health Service Act (PHS Act). F" -- https://www.fda.gov/media/135421/download

[3] https://www.federalregister.gov/documents/2020/02/21/2020-03505/definition-of-the-term-biological-product

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/

[2] http://vitaminlawyerhealthfreedom.blogspot.com/2017/01/ftc-wants-disclaimers-on-homeopathy.html

[3] https://www.fda.gov/ucm/groups/fdagov-public/@fdagov-drugs-gen/documents/document/ucm589373.pdf

[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

[5] http://www.hpus.com/legal-status.php

[6] http://www.webdc.com/pdfs/deathbymedicine.pdf

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

http://www.fda.gov/MedicalDevices/DigitalHealth/MobileMedicalApplications/default.htm

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.

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

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 Registration – Biennial 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...

FDA Food Registration Rule Change

FDA FOOD REGISTRATION RULE CHANGE

Earlier this month the FDA Food Safety Center finalized the rule regarding the registration of food-handling facilities, making some changes in details. Generally, any facility that handles food must be registered with the FDA, and therefore, subject to FDA inspection (in addition to state and local food safety inspections).  The full update is at: http://www.fda.gov/Food/NewsEvents/ConstituentUpdates/default.htm

The registration requirement was part of the 2010 Food Safety Modernization Act (FSMA).

The Amendments to Registration of Food Facilities final rule updates FDA’s food facility registration requirements by requiring additional registration information for the food facility registration database for facilities both in the United States and abroad.

Food facilities that manufacture/process, pack or hold food for consumption in the United States are required to register with the FDA, and this final rule adds new provisions to the current regulations to codify certain provisions of FSMA that were self-implementing and effective upon enactment of FSMA.

Those provisions include the requirement of an email address for registration, required renewal of registration every two years, and that all food facility registrations must contain an assurance that the FDA will be permitted to inspect the facility at the times and in the manner permitted by the Federal Food, Drug and Cosmetic Act.

In addition, the final rule adds certain new technical requirements for the facility registration system. All food facility registrations are required to be submitted to the FDA electronically, although this requirement does not take effect until January 4, 2020.

Registrations are now required to contain the type of activity conducted at the facility for each food product category. This is required as of the date of the final rule, July 14, 2016, which is prior to the October-December 2016 registration renewal period. Finally, beginning October 1, 2020, food facilities will need to provide a unique facility identifier (UFI) as part of the registration process.

The final rule also amends the definition of a retail food establishment in a way that expands the number of establishments that are considered retail food establishments, and that are therefore not required to register with the FDA as food facilities. The FDA states, "However, all food establishments, including retail food establishments, continue to have a responsibility to ensure their food is safe."

FDA Seeks Reinspection Fees from Vitamin Companies; Are YOUR Papers in Order?

SUMMER IS ALMOST OVER...
IT'S GETTING HOTTER!
ARE YOU READY FOR
YOUR FDA INSPECTION?

Sher Komisar, Compliance Coordinator
urges you to read Counsel Ralph’s
important message below -

then call her at: 914-966-8053

Read Counsel Ralph's new blog entry:
FDA Illegally Claims Reinspection Fees from Companies Like Yours!
http://vitaminlawyerhealthfreedom.blogspot.com/2013/08/fda-illegally-claiming-dietary.html

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"The FDA showed up unannounced. Said they'd be here for at least six days. We showed them the SOPs Counsel Ralph prepared for us. They left after two days. It was comforting to know we could call Ralph any time during this, and he was there for us." A.C. Company CEO

I am Ralph Fucetola JD and I have been called the Vitamin Lawyer because of my 40+ years of experience in the dietary supplement industry and in all of my 40+ years I have never seen the FDA more determined to pursue companies for being even slightly out of compliance.

Given the FDA has just hired 7,000 more Agents, the chance that the FDA could be knocking on your door tomorrow morning is greater than ever.

This regulatory challenge has become more serious recently and the future appears increasingly dangerous for not just start-up and established vitamin companies, but for every physician, chiropractor or other health care practitioner who owns his or her own "private label" products.The Natural Products Association (NPA) warned us in an email June 2013:

“FDA inspections involve a comprehensive look at your standard operating procedures (SOPs), equipment, laboratory controls, records, operating conditions, and more.  If areas of non-compliance are discovered, FDA could use any of these as evidence to issue a Form 483 warning. Do you also know how to prevent minor non-compliance from turning into a warning letter, or worse, a consent decree?”

I train your staff to bring your company into full regulatory compliance through my fairly simple four step process

1) Customization -- Working with your CEO I will customize my Standard Operation Procedures and Good Manufacturing/Marketing Procedures to you company's needs.

2) Set-Up  --  I work with your company for proper and precise implementation of the SOPs, including production logs, Product Claim Language control, definition & substantiation, and also help you prepare the FDA required S&F Claims Notice.

3) Training  --  It's not enough to have procedures. The FDA says: 'train your team and prove they' are qualified'

4) Certification -- This is the final goal of the Compliance Program, receiving your Certification. Your whole team needs to be certified in the SOP procedures which I will customize for your company.

I’ve asked long-time natural products marketer and nutritional consultant Sher Komisar to coordinate the Program since my time will be needed for personal interaction with participating companies.   rf

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But nothing will happen unless you pick up your phone now!
You Should Call Sher Komisar at 914-966-8053 NOW!

Thank you for reading Counsel Ralph’s message. I look forward to working with you, to prepare you for your FDA inspection.

    Sher

Compliance Certification Program

… Vitamin Lawyer.com ConsultancyUpdate eMemo – 01.04.2013 

THE VITAMIN LAWYER REGULATORY
COMPLIANCE CERTIFICATION PROGRAM!

My New Web Site! www.SOPcertification.com 

 
Natural Products Association (NPA) Confirms
That FDA Inspections will Reach ALL Label-Holders!

 
Welcome to the Update eMemo... helping the natural products and services industry comply with lawful regulatory standards...
 

My New Video

http://www.youtube.com/watch?v=tQgCE4q5HeM&feature=share&list=UUCvaRfOxO206K5NxFvVzGMA
 

eMail me at: ralph.fucetola@usa.net with 'SOP' in the Subject Line
 

Vitamin Lawyer Connections

 
Yes, you do need clinical trials! Further Services You Need!

A Third-Party Clinical Trial of your product; you can no longer fully rely on published science about isolated ingredients – This can cost up to several hundred thousand dollars. NCT offers a Minimal Clinical Trial from $25,000.  

New site: www.NaturalClinicalTrials.net

WHAT SHOULD YOU DO? Contact me NOW!  973.300.4594

 
The longer you put off addressing any of the above issues,
the more at-risk is your company!
 


Special Service for EU Cosmetics Dossiers: You can sell in the EU without prior governmental approval, if you have a Dossier from NCT! Please take a look at our new Webinar linked from this web page: http://www.naturalclinicaltrials.com/NCT-EU-Cosmetics.php.
 
Vitamin Lawyer Connections…
Do you Skype? If so, free Skype.com is one of the easiest ways to contact me, 
no matter where I may be.
My Skype handle is: vitaminlawyer
 
Do you have an affiliation program? We’d like to list it.
If you don’t have an affiliate program… I have Affiliate Program SOPs & Rules …
And good advice… for you.“One on One with the Vitamin Lawyer” from Power Pictures Inc.
Trailer: www.youtube.com/watch?v=wWPvzpn0YgA www.powerpicturesllc.com – Airing on: www.telostv.com
Follow me on Twitter - www.twitter.com/healthfreedomus 
 
 THESE UPDATE MEMOS NOW ARCHIVED AT:
 http://vitaminlawyerarchives.blogspot.com/
 
ralph …
Ralph Fucetola JD
Notary Public of the State of New Jersey #2398815
Attorney at Law in NJ – 1971 - 2006 – All Rights Reserved.