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Updated by Eileen Hall on Oct 10, 2017
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Eileen Hall Eileen Hall
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FDA Warning Letters

If you received any FDA Warning Letters by FDA authorities, then take an absolute solution from our expert FDA Consultants.

Worried about FDA warning letters? We can assist you

If you have received FDA warning letters that you have no idea how to tackle, we are here to help you with our particular skill-set and years of experience.

FDA Advises Consumers to Avoid Using Dietary Supplements with Undeclared Drugs

On April 7, 2014, the U.S. Food and Drug Administration ("FDA") advised consumers to stop taking Zi Xiu Tang Bee Pollen products, which are promoted as body forming, weight loss fda dietary supplements. According to the FDA, the Company's dietary supplements include at least one potentially dangerous pharmaceutical ingredient that is not declared on the product label.

Comply with the 30-day notification for FDA dietary supplements

Under federal law, FDA dietary supplements may make certain claims on product labeling. These claims, referred to as "structure-function claims", may be made on product labels and in product labeling (consisting of websites and other marketing materials) provided that: (1) the claim includes a mandatory disclaimer, (2) such claims are truthful and not misleading, and (3) the firm has notified FDA within 30 days of marketing the product bearing the claim (30-day notification).

FDA Advises Consumers to Avoid Using Dietary Supplements with Undeclared Drugs

On April 7, 2014, the U.S. Food and Drug Administration ("FDA") advised consumers to stop taking Zi Xiu Tang Bee Pollen products, which are promoted as body forming, weight loss dietary supplements. According to the FDA, the Company's dietary supplements include at least one potentially dangerous pharmaceutical ingredient that is not declared on the product label.

We help you comply with the FDA health claims regulations

Because the FDA generally classifies the products it regulates based on intended use and ingredients found therein, among other considerations, an initial stage in determining how a product will be regulated is by looking to the intended use. FDA Health claims are required to be reviewed and evaluated by FDA prior to use. Health claims on food labels are claims by manufacturers of food products. However, the FDA has determined that this evidence is limited and not conclusive.

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If you have received FDA warning letters that you have no idea how to tackle, we are here to help you with our particular skill-set and years of experience.

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Because the FDA generally classifies the products it regulates based on intended use and ingredients found therein, among other considerations, an initial stage in determining how a product will be regulated is by looking to the intended use. Health claims are required to be reviewed and evaluated by FDA prior to use. For more information please visit http://giannamore-law.com/our-services/health-claims/

FDA Advises Consumers to Avoid Using Dietary Supplements with Undeclared Drugs

On April 7, 2014, the U.S. Food and Drug Administration ("FDA") advised consumers to stop taking Zi Xiu Tang Bee Pollen products, which are promoted as body forming, weight loss dietary supplements. According to the FDA, the Company's dietary supplements include at least one potentially dangerous pharmaceutical ingredient that is not declared on the product label.

Health claims are required to be reviewed and evaluated by FDA prior to use. Health claims on food labels are claims by manufacturers of food products. However, the FDA has determined that this evidence is limited and not conclusive.