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

 

View this email in your browser

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

 

View this email in your browser

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.