# FDA WARNING_LETTER - Theoriginalhcgdrops.com - Unknown Date

Source: https://www.keypedia.com/records/warning_letter/theoriginalhcgdropscom/020b604d-2aa8-459c-bdbc-987b140d406c

> FDA WARNING_LETTER for Theoriginalhcgdrops.com on Unknown Date. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Theoriginalhcgdrops.com
- Product Type: Drugs
- Office Name: New York District Office
- Summary: On November 28, 2011, the FDA and FTC issued a Warning Letter to Dr. Gary Arbuckle and Ms. Amy Freeze, regarding their products "Homeopathic Original HCG" and "Homeopathic HCG," marketed on theoriginalhcgdrops.com and resetthebody.com.

The FDA determined these products are unapproved new drugs, violating Sections 301 and 505 of the Federal Food, Drug, and Cosmetic Act (the Act), and are misbranded under Sections 503 and 301. The FTC found that advertising claims, such as "The Weight Loss Cure" and "Lose 20-30 pounds in 30-40 days," lacked competent and reliable scientific evidence, violating the FTC Act.

The products are considered drugs under Section 201(g)(1) of the Act due to their intended effects on the body, and "new drugs" under Section 201(p) as they are not generally recognized as safe and effective. No FDA-approved application exists for these products.

Despite being labeled homeopathic, HCG is not an established homeopathic active ingredient in the Homeopathic Pharmacopeia of the United States (HPUS), thus not falling under the FDA's enforcement policies for homeopathic drugs (CPG 7132.15). Furthermore, the products are deemed prescription drugs under Section 503(b

## Related Officers

- [Amy Freeze](https://www.keypedia.com/people/amy-freeze/38fd39a6-b64c-412a-8274-2e9ed981ee16)
- [Gary Arbuckle](https://www.keypedia.com/people/gary-arbuckle/62f9c4e2-2504-475c-9031-c6cdb31305f8)
- [Associate Director](https://www.keypedia.com/people/mary-k-engle/9426dfba-028c-4d3a-bb62-7bdea653e6bc)
- [Program Director](https://www.keypedia.com/people/ronald-m-pace/a79d2af4-650e-4220-8de1-92bbd284457d)
- [Deputy Director](https://www.keypedia.com/people/ilisa-bg-bernstein/d6f2e256-6192-4fe1-9a90-e077cf7a8e14)

Company: https://www.keypedia.com/companies/theoriginalhcgdropscom/844e00fd-f6dc-433d-abf2-0c402fbd18ce

Office: https://www.keypedia.com/offices/new-york-district-office/9fa3d265-16ca-438d-8a6e-b47f60dc260d