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Re: Regis999 post# 16246

Monday, 01/06/2014 5:52:16 PM

Monday, January 06, 2014 5:52:16 PM

Post# of 30990
I'm sorry to be a downer, but I don't believe the person who wrote that investment letter did enough research. There is a fine line and its not clear to me what side anatabloc will fall on.

This much is true apparently: "With the exception of infant formula, neither FDA nor FSIS has the authority to require a company to recall an adulterated food product."

However:
"If a food is adulterated, FDA and FSIS have a broad array of enforcement tools.They are of various types. These include seizing and condemning the product, detaining imported product, enjoining persons from manufacturing or distributing the product, or requesting a recall of the product."

"Enforcement action is usually preceded by a Warning Letter from FDA to the manufacturer or distributor of the adulterated product."

"many states have the authority to immediately embargo adulterated food and to impose civil fines. Federal agencies often will coordinate with state or local authorities to remove unsafe food from the market as quickly as possible."

Before you start attacking my position, can you do it on the basis of facts, legal precedents etc or whatever research you can find?

Details below
============================================
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2013/ucm379639.htm#
"In addition, your Anatabloc and CigRx products contain anatabine as a dietary ingredient. While anatabine has been authorized as an investigational new drug, it is also considered a new dietary ingredient, which is subject to premarket approval. To date, a premarket notification has not submitted to FDA, for your products containing anatabine; therefore, they are deemed to be adulterated. As explained further below, introducing or delivering these products for introduction into interstate commerce for such uses violates the Act."


http://en.wikipedia.org/wiki/Adulterated_food
"If a food is adulterated, FDA and FSIS have a broad array of enforcement tools.They are of various types. These include seizing and condemning the product, detaining imported product, enjoining persons from manufacturing or distributing the product, or requesting a recall of the product. Enforcement action is usually preceded by a Warning Letter from FDA to the manufacturer or distributor of the adulterated product. In the case of an adulterated meat or poultry product, FSIS has certain additional powers. FSIS may suspend or withdraw federal inspection of an official establishment. Without federal inspection, an establishment may not produce or process meat or poultry products, and therefore must cease operations. With the exception of infant formula, neither FDA nor FSIS has the authority to require a company to recall an adulterated food product. However, the ability to generate negative publicity gives them considerable powers of persuasion.

State regulators generally have similar enforcement tools at their disposal to prevent the manufacture and distribution of adulterated food. In addition, many states have the authority to immediately embargo adulterated food and to impose civil fines. Federal agencies often will coordinate with state or local authorities to remove unsafe food from the market as quickly as possible."

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