# FDA WARNING_LETTER - Plum Dragon Herbs, Inc. - August 15, 2012

Source: https://www.keypedia.com/records/warning_letter/plum-dragon-herbs-inc/e0855bf1-a38b-4e8b-b1e2-7548d4a741bc

> FDA WARNING_LETTER for Plum Dragon Herbs, Inc. on August 15, 2012. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Plum Dragon Herbs, Inc.
- Inspection Date: 2012-08-15
- Product Type: Drugs
- Office Name: Department of Health and Human Services
- Summary: The FDA issued a Warning Letter to Dragon Herbs on August 15, 2012, following a review of their website (www.dragonherbs.com) in July 2012 and their 2nd Edition Catalog, also found online and collected at the 2012 Natural Products Expo West. The FDA determined that numerous products, including "CardioPro 2000," "Cordyceps," and "Activated Minor Bupleurum," are promoted with therapeutic claims that classify them as unapproved new drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(g)(1)(B)].

The letter cites specific claims from the website and catalog, such as "Activated Minor Bupleurum" having "excellent anti-viral functions," "Standardized Scute" restoring effectiveness of antibiotics against MRSA, and "Salacia" regulating sugar imbalance. Other products were marketed with claims related to lowering cholesterol, anti-tumor activity, regulating blood pressure, preventing bleeding, and aiding in withdrawal from addiction. The "HIV Lifestyle Program" also recommended "powerful immune-boosting formulas."

These products are considered "new drugs" under section 201(p) of the Act [21 U.S.C. § 321(p)] because they are not generally

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