NOT FOR HUMAN CONSUMPTION: HOW TO SPOT HIGH-RISK MERCHANTS HIDING IN PLAIN SIGHT

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1 NOT FOR HUMAN CONSUMPTION: HOW TO SPOT HIGH-RISK MERCHANTS HIDING IN PLAIN SIGHT

2 AGENDA 1 COSMETIC MERCHANTS 2 ADULT PRODUCT MERCHANTS 3 RESEARCH INGREDIENT MERCHANTS 4 BOTANICAL AND FLORAL MERCHANTS 5 SUPPLEMENT MERCHANTS 2

3 COSMETIC MERCHANTS HIDING PRESCRIPTION-ONLY TOPICAL DRUGS

4 Legal Sale of Prescription-Only Drugs Three requirements: Prescription-only drugs must be dispensed to patients by an authorized healthcare provider (typically a pharmacy but sometimes also a physician, depending on state law) that is licensed (or permitted to practice via reciprocity) in the patient s jurisdiction. Prescription drugs must be dispensed pursuant to a valid prescription. The drugs must be authorized, either via FDA approval or by meeting a regulatory exception to approval, for sale in the patient s jurisdiction. COSMETIC MERCHANTS 4

Examples: make-up, perfume, moisturizers, deodorants (antiperspirants are drugs), hair dye.

5 Is it a Cosmetic or a Prescription-Only Drug? Cosmetics are topical products that make cosmetic claims (moisturizing, beautifying, cleansing). Examples: make-up, perfume, moisturizers, deodorants (antiperspirants are drugs), hair dye. Drugs can LOOK like cosmetics, especially foreign topical drugs. Foreign products: often sell drug version and cosmetic version under same brand name. Confusing fact: TRUE cosmetics can legally contain drug ingredients (sometimes). COSMETIC MERCHANTS 5

6 Rx drugs commonly sold on cosmetic websites Common prescription-only ingredients sold on cosmetic websites: betamethasone, hydroquinone (4%), tretinoin, bimatoprost, clobetasol. Rx ONLY COSMETIC MERCHANTS 6

Per the FDA, these products are unapproved new drugs.

7 Injectable Whitening Products FDA has taken action against websites selling injectable drugs marketed for whitening. Per the FDA, these products are unapproved new drugs. Typically contain glutathione, vitamin C, collagen, and even human placenta. Other countries have taken action (e.g., France and the Philippines). COSMETIC MERCHANTS 7

8 Injectable Whitening Products: Examples COSMETIC MERCHANTS 8

9 ADULT PRODUCT MERCHANTS HIDING INHALANTS AND PRESCRIPTION DRUGS

Inhalants ( Poppers ) In the US, nitrites specifically, butyl

banned hazardous products under the Consumer Product Safety

That s why poppers are marketed as leather cleaner and room

10 Inhalants ( Poppers ) In the US, nitrites specifically, butyl nitrite, isopropyl nitrite, and volatile alkyl nitrites are banned hazardous products under the Consumer Product Safety Act, with exceptions for commercial use. That s why poppers are marketed as leather cleaner and room odorizer. Health Canada has taken action against poppers. A-OK in the UK! ADULT PRODUCT MERCHANTS 10

11 Poppers: Commonly Sold Alongside Adult Goods ADULT PRODUCT MERCHANTS 11

12 Prescription-Only Sexual Enhancement Drugs Drugs are often sourced from foreign countries and may not be immediately recognizable as drugs (e.g., prescription-only drugs as gummies). Websites mostly sell adult toys and male enhancement supplements. ADULT PRODUCT MERCHANTS 12

13 RESEARCH CHEMICAL/PEPTIDE MERCHANTS HIDING INJECTABLE UNAPPROVED DRUGS AND CONTROLLED SUBSTANCES

Research Chemical Merchants Selling synthetic

(e.g., AB-FUBINACA, PB-22, 5F-PB-22, ABD-PINACA) All

14 Research Chemical Merchants Selling synthetic cannabinoids and cathinones Selling ingredients used to make designer drugs. Some ingredients are Schedule I controlled substances (e.g., AB-FUBINACA, PB-22, 5F-PB-22, ABD-PINACA) All ingredients are intended for psychoactive purposes. RESEARCH CHEMICAL/PEPTIDE MERCHANTS 14

15 Research Chemical Merchants: Indicators of Illegality RESEARCH CHEMICAL/PEPTIDE MERCHANTS 15

16 Research Peptide Merchants Marketed to bodybuilders. FDA/DOJ has repeatedly taken action. Numerous disclaimers: For research/laboratory purposes only Advertised in bodybuilding magazines and conventions. RESEARCH CHEMICAL/PEPTIDE MERCHANTS 16

17 Research Peptide Merchants Marketed to Bodybuilders: Limited product catalog vs. 1,000s of products Typically sell a limited number of prescription-only ingredients: anastrozole, clomiphene, finasteride, letrozole, sermorelin, sildenafil, tadalafil, and tamoxifen. Other commonly seen ingredients: melanotan (1 and 2), CJC-1295, GHRP-2, GHRP- 6, hexarelin, ipamorelin RESEARCH CHEMICAL/PEPTIDE MERCHANTS 17

18 BOTANICAL AND FLORAL MERCHANTS HIDING PSYCHOACTIVE HIGHS AND CONTROLLED DRUGS

Peyote and Poppy Pods Both are controlled

Poppy pods: look out for merchants claiming

19 Peyote and Poppy Pods Both are controlled substances (the actual plants). Peyote (Lophophora williamsii): there is a religious exemption, but it is very narrow. Poppy pods: look out for merchants claiming their products are unwashed and untreated. BOTANICAL AND FLORAL MERCHANTS 19

20 Poppy Pods: Transaction Laundering BOTANICAL AND FLORAL MERCHANTS 20

FDA has declared kratom a new dietary ingredient about which there is inadequate information to

21 Kratom and Other Botanicals Not specifically illegal but highrisk: Mimosa hostilis (marketed as dye); San Pedro cactus. Kratom is currently a DEA Drug of Concern (but not yet a C1). FDA has declared kratom a new dietary ingredient about which there is inadequate information to provide assurance regarding its safety so it s not OK in dietary supplements. BOTANICAL AND FLORAL MERCHANTS 21

22 SUPPLEMENT MERCHANTS HIDING PRESCRIPTION-ONLY DRUGS

Many supplement ingredients are Rx in other countries Yohimbine (common supplement ingredient) is prescription-only in at least ten countries.

23 Many supplement ingredients are Rx in other countries Yohimbine (common supplement ingredient) is prescription-only in at least ten countries. DHEA is a controlled substance in a number of countries, including the UK, Brazil, and Canada. Some manufacturers often international versions. Where is the merchant marketing its products? Check the drop-down menu. SUPPLEMENT MERCHANTS 23

The Shifting Federal Regulation of Cannabis Products

The Durham Bar 2019 CLE Program The Shifting Federal Regulation of Cannabis Products Erica M. Jackson, FDA Partner K&L Gates February 6, 2019 Copyright 2018 by K&L Gates LLP. All rights reserved. OVERVIEW