Wednesday, May 26, 2021

May 2021 Newsletter: Defining 'Healthy'

 

Vitamin Consultancy May 2021 Newsletter

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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

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Friday, March 12, 2021

March 2021 Newsletter: Commercial Freedom Of Speech

 


Systems Processing Integration

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

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Wednesday, January 20, 2021

January 20, 2021 Newsletter


Vitamin Consultancy Newsletter
www.VitaminConsultancy.com

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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.

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