November 2022 Newsletter: Free Export Guidance

 

FDA Free Export Guidance The FDA has provided a formal Guidance on the exporting of products not approved for use in the USA. That Guidance begins: “This guidance document summarizes and explains the basic requirements and procedures under the FDA Export Reform and Enhancement Act of 1996 (Public Law 104-134, as amended by Public Law 104-180) for exporting human drugs, animal drugs, biological products, devices, food, food additives, color additives, and dietary supplements that may not be sold or distributed in the United States.” A Review of the Guidance strongly suggests that FDA allows the broadest export authority without prior FDA approval. The Summary Chart provides for export under Section 801(e)(1). Page 18 of the Guidance sets out the 801 requirements: “Section 801(e)(1) of the Act states that a food, drug, device, or cosmetic intended for export shall not be deemed to be adulterated or misbranded if the article: • Accords to the specifications of the foreign purchaser; • Is not in conflict with the laws of the country to which it is intended for export; • Is labeled on the outside of the shipping package that it is intended for export; and • Is not sold or offered for sale in domestic commerce.” Conclusion: A company relying on 801 has to maintain records of the transaction showing compliance with the above provisions and provide the records to the FDA in the event of an inspection. There is no pre-export filing required. https://www.fda.gov/media/138075/download

CHRONO CREATIONS MY SON DREW FUCETOLA IS TAKING ON A FEW NEW CLIENTS FOR HIS COMPUTER CONTROL SYSTEM CONSULTING FIRM. FREE ANALYSIS OF YOUR PROCESSING SYSTEMS. GET THE MOST UPDATED APPS AVAILABLE! Contact me at ralph.fucetola@gmail.com with ‘Chrono’ in the subject line.

ERC: EMPLOYEE RETENTION CREDIT Have you seen the TV ads for this multi-billion dollar program? Get some of your taxes back… How to Apply for the Employee Retention Credit (ERC) Under the CARES Act [These 70% Retention Credits are in addition to any PPP loans and are a free grant, no payback. Available to small businesses up to 499 employees.] 1) Watch the 5 minute ERC video with this link: https://www.jornscpa.com/snap/?refid=11450617 2) Click on "See If You Qualify" to submit contact info to the Accounting Firm. 3) If qualified and if Company wants to apply, sign the Engagement Letter. 4) If you have further questions, I can set up a call with the Jorns Firm to get questions answered before sign up. ------------------------------------- Vitamin Consultancy Archive Link: https://us14.campaign-archive.com/home/?u=b90078d41a788bb042d5af1db&id=5487712bce

Durbin Bill and DSHEA

 

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Durbin and Braun Bill Seeks to Register All DSHEA Products DIETARY SUPPLEMENT FALSE ‘TRANSPARENCY’ BILL ACT HERE NOW: https://inhere.salsalabs.org/DurbinDSBill Senators Durbin and Braun have issued a Media Release proposing further legislative restrictions on the availability of dietary supplements. The bill has the innocuous sounding title of The Dietary Supplement Listing Act of 2022. Since Sen. Durbin is the current Majority Whip the bill stands a good chance of passing before the upcoming congressional election. In the Release Sen. Durbin admitted, “Seventy percent of people in America take a dietary supplement including me.” The proposal is to have all dietary supplements ‘registered’ with the Food and Drug Administration (FDA) because, the Senators imply, since Congress unanimously passed the Dietary Supplement Health and Education Act of 1994 (DSHEA) the number of dietary supplement products available to the public has increased from about 4,000 to an estimated 80,000. We reject the authoritarian notion that, because Americans want nutrients and therefore nutrient companies are successful, they ought to be further regulated and restricted. Unlike pharmaceutical drugs which, even when used according to prescription, may kill over 500,000 Americans annually there are virtually no adverse reactions reported for dietary supplements. There is no public health reason to register nutrients which are foods deemed safe when used as directed. If there were to be a serious adverse reaction to a nutrient the current law requires notification to FDA. Additionally dietary supplement marketers are already required to notify FDA regarding each claim made for each dietary supplement within 30 days of making the claim. Further, all manufacturers of dietary supplements must register with FDA as food processing facilities. The Senators are wrong to imply that FDA needs additional power to “regulate” supplements. Since there is no compelling reason to add another layer of registration and notification above those that already exist, and such registration will be an additional burden on especially smaller companies, the Durbin/Braun proposal should be rejected. The Bill is just another power grab to limit access to the market and availability of affordable nutrients. We have initiated a campaign to educate supplement users regarding the Durbin/Braun proposal, providing the public with an easy “Action Item” through the system that operates the Natural Solution email list. The goal is for the Action Item to ‘go viral and flood the White House and each individual’s Senators and Member of Congress with our concerns. HERE IS THE LINK TO THE ACTION ITEM https://inhere.salsalabs.org/DurbinDSBill Share with all your circles of influence and act now or your access to nutrients will be at risk. Share with this link: http://www.opensourcetruth.com/stop-durbin-braun-vitamin-registration-bill/ Support this campaign here: https://fundly.com/support-natural-therapies

March 2022 Newsletter: Useful Links

 

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The Vitamin Consultancy Newsletter This is my first newsletter since December 2021, so I’m sending you some important links with information to impact your bottom line. Regards, Ralph…

I continue to offer consulting services through www.VitaminConsultancy.com and www.SystemsProcessingIntegration.com — Mention the Vitamin Consultancy Newsletter and I’ll give you ten percent off any invoice during April, the month when I am acknowledging my 77th birthday.

Ann and Bill Chaisson, with whom I have worked since the late 1960s have a new web site for their beautiful .925 silver Sons and Daughters of Liberty medallions. I proudly wear my SoL medallion, which only gains value over time. https://www.libertyhillpatriots.com/productss

Shop Here

You Need Drew’s IT Networking Skills! My son Drew, after three years running the IT network for an expanding Dallas warehouse distribution system (now about one million square feet), is working with his wife Sophie as office manager, to establish his own consulting practice, www.ChronoCreation.com Chrono Creation Systems is the company that creates time for you… and, time is money, so your bottom line always benefits more from Drew and Sophie’s services than you pay. Imagine that! Contact them at: https://www.chronocreation.com/chronocreation/contact-us Here is what they do: Produce advanced integrative software to automate systems within your business, getting your systems to ‘talk’ to each other efficiently, to: Reduce employee workload and therefore employee time. Create time for efficient productivity. Provide satisfactory and personal customer support. Unique software built specifically for your business needs. Improve your bottom line.

May 2021 Newsletter: Defining 'Healthy'

 

Vitamin Consultancy May 2021 Newsletter

Are Your Products “Healthy”? FDA posted the following Notice earlier this month. The U.S. Food and Drug Administration is issuing a procedural notice on the preliminary quantitative consumer research it plans to conduct on symbols that could be used in the future to convey the nutrient content claim “healthy.” As part of the Paperwork Reduction Act, Federal agencies are required to publish notice in the Federal Register on each proposed information collection and to give the public the opportunity to comment. The FDA is conducting the research in conjunction with the development of a proposed rule the FDA intends to later publish that would update when manufacturers may use the “healthy’ nutrient content claim on food packages. The symbol would be a stylized representation of the nutrient content claim. The update to the definition and creation of a symbol for the “healthy” nutrient content claim are part of the FDA’s Nutrition Innovation Strategy (NIS). The NIS is intended to reduce the burden of nutrition-related chronic diseases, which are experienced at a disproportionately higher rate by communities of color. One of the elements of the NIS is to modernize claims, which serve as quick signals for consumers about what benefits a food or beverage they choose might have. Claims and symbols can also help consumers better understand nutrition information and can encourage companies to reformulate products to improve their nutritional value. The FDA is seeking comment on ways to enhance the quality, usefulness, and clarity of the information to be collected. Comments on the notice are due 60 days following publication in the Federal Register. Submit comments electronically to https://www.regulations.gov. Written comments should be addressed to: Dockets Management Staff (HFA-305) / Food and Drug Administration / 5630 Fishers Lane, Rm. 1061 - Rockville, MD 20852 Please consider filing your suggestions with the FDA at the indicated link. Source: https://www.fda.gov/food/cfsan-constituent-updates/fda-issues-procedural-notice-consumer-research-healthy-symbol

Vitamin Consultancy Services As your business gets ready for the end of the lockdowns you need to review your regulatory status. There are new rules… I am available to work with your company to make sure your SOPs and other procedures are up-to-date. Just give me a call! 973.300.4594 SPECIAL REOPENING RATES! www.SystemsProcessingIntegration.com

March 2021 Newsletter: Commercial Freedom Of Speech

 

Vitamin Consultancy Newsletter www.VitaminConsultancy.com 12 March 2021 — The Federal Appeals Court that serves the West Coast made a decision that supports commercial freedom of speech regarding dietary supplements. Reuters reports: A class action lawsuit accusing big box retailer Target Corp and nutritional supplement makers International Vitamin Corp and Perrigo Co of falsely marketing biotin, a nutritional supplement, as promoting healthy hair and skin is preempted by federal law, a federal appeals court has ruled. A unanimous panel of the 9th U.S. Circuit Court of Appeals held …that the claims made on the supplement’s label were protected by the federal Food, Drug and Cosmetic Act (FDCA) as general claims about the structure and function of biotin, and that the product included appropriate disclaimers, affirming a lower court order dismissing the case. What this means is that States like California cannot impose stricter “false advertising” rules than the Federal Government imposes. It means there is a national standard for claims. When general structure and function claims are made — with appropriate disclaimers — Federal law protects the claims. Isn’t it time for us to review your claims and make sure your disclaimers are in order? Just email me: ralph.fucetola@gmail.com with “Review” in the subject line. Ten percent off my regular rates if you email your questions. While claims are the key for marketing natural products, including dietary supplements, careful consideration of claims is not enough to keep you in business. Your processing system must be “in order” and, as FDA says, you “must be in a state of control” at all times. My SPI System allows you to meet the state-of-the-market requirements for transparency and traceability. Please check out my www.SystemsProcessingIntegration.com web site and let’s talk about what parts of the SPI System you can start to implement first. The sooner, the better… 973.300.4594

January 20, 2021 Newsletter

Vitamin Consultancy Newsletter www.VitaminConsultancy.com

While the declared “pandemic” has slowed bureaucracy to a crawl, one appeals court recently made a decision that supports commercial freedom of speech regarding dietary supplements. Reuters reports: A class action lawsuit accusing big box retailer Target Corp and nutritional supplement makers International Vitamin Corp and Perrigo Co of falsely marketing biotin, a nutritional supplement, as promoting healthy hair and skin is preempted by federal law, a federal appeals court has ruled. A unanimous panel of the 9th U.S. Circuit Court of Appeals held Wednesday that the claims made on the supplement’s label were protected by the federal Food, Drug and Cosmetic Act (FDCA) as general claims about the structure and function of biotin, and that the product included appropriate disclaimers, affirming a lower court order dismissing the case. What this means is that States like California cannot impose stricter “false advertising” rules than the Federal Government imposes. It means there is a national standard for claims. When general structure and function claims are made — with appropriate disclaimers — Federal law protects the claims. Isn’t it time for us to review your claims and make sure your disclaimers are in order? Just email me: ralph.fucetola@usa.net with “Review” in the subject line. Ten percent off my regular rates if you email your questions.

Time to Try Some Crypto

"The times they are a changing..." Never thought I'd see the Banana Republic spectacle of the new regime being installed in Washington, DC by 25,000 soldiers carefully vetted by the deep state, contrary to the actual electoral will of the people. Sad days coming -- the promised "dark winter." One thing for certain, the US dollar will evaporate as the artificial COVID boom pops. The Fed Debt is about to accelerate as the new regime tries to "stimulate" itself out of the disaster. Where to go for protection? Maybe now's the time to put a toe into crypto. I've joined HoneyMiner which is an easy way to begin to experience Bitcoin. The system is a small program that runs in the background on your computer whenever it is on. It uses your excess processing capacity to mine crypto with you and the company sharing the crypto. Start with 1,000 Satoshis free. More here: https://honeyminer.com/referred/5tviv

December 2020 Newsletter

 

The Vitamin Consultancy Newsletter 11 December 2020 Ralph Fucetola JD

It's Time to Get Ready for What’s Next GETTING READY FOR THE NEW YEAR AND NEW REGIME Now more than ever “your papers must be in order.” But First… Are You Interested in Cryptocurrency? OF COURSE YOU ARE! Join Honey Miner It is a no-cost (except the cost of your computer time) BTC miner that uses your excess CPUs to generate crypto even while you are not using your computer.  I've already earned a couple dozen Satori (a Satori is 1/1,000,000 BTC) in the four hours I've been a member.  This program was recommended by my nephew Jeff Giles who is very savvy about crypto.  You can put all your computers on the system and the program will keep track of your Satori rewards. Easy download and set-up. Join now and get 1,000 Satoris to start.  You can earn more crypto by asking others to join.  Once your HM Wallet is set up you can receive and send BTC to others... in other words, you are part of the crypto revolution! Join through me here:  https://honeyminer.com/referred/5tviv

Some Useful Links: http://vitaminlawyerarchives.blogspot.com/ https://vitaminlawyerhealthfreedom.blogspot.com/ https://www.minds.com/groups/profile/1171655581270441984/feed GETTING READY FOR 2021 My Systems Processing Integration  Will Give Your Company Peace of Mind www.SystemsProcessingIntegration.com