Daniel Fabricant, Ph.D

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1 Daniel Fabricant, Ph.D NIA West Spring Conference May 22, 2018

Who We Are Largest and oldest natural products

including: Dietary supplements & ingredients

2 Who We Are Largest and oldest natural products trade group in U.S. established in 1936 Represent almost 1100 retailers and suppliers of natural products including: Dietary supplements & ingredients Natural and organic foods Cosmetics, health and beauty aids Approx. 10,000 storefronts

3 What We Do Our Mission As the leading voice of the natural products industry, the Natural Products Association's mission is to advocate for the rights of consumers to have access to products that will maintain and improve their health and well being, and for the rights of retailers and suppliers to sell these products. NPA helps consumers maximize their health and wellbeing by working with the natural product industry at large to set industry standards, certify products to those standards, and ultimately promote and make it easy to identify truly natural products.

4 Vision

5 CANNABIDIOL (CBD)

6 Cannabidiol (CBD) Found in marijuana (listed as Schedule I of Controlled Substances Act) Also found in industrial hemp, a plant that can legally be cultivated under the 2014 Farm Bill. Botanically, both are Cannabis sativa under the Linnean definition Some stipulate that under federal law, hemp is defined as cannabis Sativa plants with less than 0.3 % THC. Anything more is marijuana. DEA s December 2016 decision that CBD, and any other cannabis extract that also contains a single cannabinoid, is absolutely marijuana and thus subject to enforcement.

7 Cannabidiol (CBD) The Controlled Substances Act regulates the possession and sale of certain substances, including marijuana. 21 U.S.C. 812(c), Schedule I (c)(10) July 5, 2011, the DEA issued a notice of proposed rulemaking (NPRM) that would establish a new drug code specifically for marijuana extract. The DEA reasoned that the new code would assist the U.S. in complying with certain drug-control treaties. Final Rule was published on December 14, 2016 Rule went into effect on January 13, 2017

8 Establishment of a New Drug Code for Marijuana Extract Drug Enforcement Administration Final Rule Published in Federal Register December 14, 2016 DEA creating a new Administration Controlled Substances Code Number for Marijuana Extract. DEA creating separate code number for marijuana extract with the following definition: Meaning an extract containing one or more cannabinoids that has been derived from any plant of the genus Cannabis, other than the separate resin (whether crude or purified) obtained from the plant. Extracts of marijuana will continue to be treated as Schedule I controlled substances.

9 Hemp Industries Association VS. U.S. Drug Enforcement Administration Petitioners claim the final rule confits with portion of Agricultural Act of 2014 and Consolidated Appropriations Act of 2016 The Agricultural Act contemplates potential conflict between the Controlled Substances Act and preempts it. The Final Rule therefore does not violate the Agricultural Act. Consolidated Appropriations Act forbids the use of federal funds from being used in contravention of... the Agricultural Act or to prohibit the transportation, processing, sale, or use of industrial hemp that is grown or cultivated in accordance with subsection section 7606 of the Agricultural Act of 2014 The comment focused on the original phrasing of the Proposed Rule, which defined extracts as containing cannabinols and cannabidiols. The commenter inquired whether this would cover 100% pure Cannabidiol by itself with nothing else? The Final Rule put this question to rest when it rephrased the definition to apply to an extract containing one or more cannabinoids Petition for Review: Denied

10 FDA Issues Warning Letters CBD, to date is not FDA approved in any drug product for any indication. April 19, 2018 the NDA for LGS approval was recommended at FDA. Final rendering of Oral CBD for LGS and related symptoms is scheduled for June 27, 2018 FDA warning letters emphasize the illegality of selling products online with unsubstantiated therapeutic claims. Selling such unapproved products violates the Federal Food Drug & Cosmetic Act No successful food additive petition, GRAS notice or New Dietary Ingredient (NDI) notification

11 FDA Issues Warning Letters Warning letters issued to 4 companies that made unfounded claims about their products ability to limit, treat or cure cancer and other serious diseases: Greenroads Health Natural Alchemist That s Natural! Marketing and Consulting Stanley Brothers Social Enterprises LLC

12 FDA Issues Warning Letters Unlike drugs approved by the FDA, manufacture of these products has not been subject to FDA review as part of the drug approval process There has been no FDA evaluation of: Whether they work What the proper dosage is How they could interact with other drugs Whether they have dangerous side effects or other safety concerns FDA requested responses from the companies stating how violations will be corrected, per our FOIA FDA has not received a response Failure to correct the violation promptly (15 business days) may result in legal action, including product seizure and injunction.

13 FDA Issues Warning Letters

14 FDA Issues Warning Letters: 20 CBD Warning Letters Issued 2014 Natural Solutions Foundation 2015 Canna Companion LLC Canna Pet LLC CBD Life Holdings LLC dba Ultra CBD Hemp Oil Care Natural Organic Solutions (Purecbd.net) Twin Falls Bio Tech, LLC 2016 ABC Productions (Cali Stores) Dose of Nature Green Garden Gold Healthy Hemp Oil Michigan Herbal Remedies, LLC Morguetorium, LLC (Morgue Juice) PainBomb, LLC Sana Te Premium Oils 2017 Green Roads of Florida LLC Natural Alchemist Stanley Brothers Social Enterprises, LLC That s Natural Vacunda & Design

15 FDA Warning Letters

16 FDA Warning Letter: New Drug/Labeling/Misbranded/Cannabidiol (CBD) Products

17 FDA Warning Letter: New Drug/Labeling/Misbranded/Cannabidiol (CBD) Products

18 GW Pharma Moving CBD Bills on the Down Low GW Pharma and its American subsidiary Greenwich BioSciences are quietly moving proprietary CBD bills through at least two U.S. state legislatures (South Dakota and Nebraska), and could have plans for similar bills in other states. The South Dakota bill, SB 95, exempts cannabidiol from the definition of marijuana and moves CBD from a state-designated Schedule I Drug to Schedule IV substance Piece of the bill that s critical to GW/ Greenwich: these moves affect only cannabidiol products that have received federal FDA approval. This bill will block all current and readily available CBD options in South Dakota If the bill passes, GW Pharma and Greenwich BioSciences will effectively own a legal monopoly on CBD products in South Dakota and Nebraska Epidiolex Developed by GW/Greenwich for the treatment of several rare childhoodonset epilepsy disorders. CBD-based drug that s recently completed Phase III clinical trials Currently the only widely known CBD product nearing full FDA approval

19 GW Pharmaceuticals: Aiming for FDA Approval of CBD Medicine GW Pharmaceuticals, British cannabis company hoping the FDA will sign off on its CBD-based epilepsy treatment, Epidiolex. Hoping to classify Epidiolex as a prescription drug, despite the fact it is derived from marijuana GW released results from a scientific study, which, the company argues, proves the drug is effective in treating patients with Lennox-Gastaut Syndrome (form of epilepsy) Over 14 week period, 44% of study participants saw significant reduction in number of seizures suffered Organized two separate clinical trials that found that Epidiolex can be effective for epileptic children suffering from Dravet Syndrome (another form of intractable epilepsy)

20 GW Pharmaceuticals Inches Closer to FDA Approval of CBD Medicine FDA has accepted filing for New Drug Application (NDA) submitted by GW Pharmaceuticals. NDA include safety data on roughly 1,500 patients, with about 400 patients having taken the medicine for more than one year. If approved by FDA, Epidiolex could hit the U.S. market in the fourth quarter of 2018 Epidiolex s launch would mark another revenue stream for CBD. CBD sales in the US across the hemp-derived, marijuana-derived and pharmaceutical industries is projected to reach $1.1 billion by Before becoming commercially available, the DEA would need to make a scheduling decision under the Controlled Substances Act (CSA) for the medicine following a recommendation by the Department of Health and Human Services.

21 GW Pharmaceuticals Inches Closer to FDA Approval of CBD Medicine: If Epidiolex is FDA Approved GW would have a marketing exclusivity period for up to 7.5 years for the indications that Epidiolex is awarded for. DEA would move it into one of the four medical schedules under the CSA, such as a schedule II controlled substance, which would place it alongside such drugs as codeine, oxycodone and fentanyl GW anticipates DEA would place Epidiolex in a less restrictive category, which includes Schedule III, IV and V controlled substances Expects the finished dosage form of Epidiolex to be controlled in Schedule IV or V It was demonstrated that CBD has a low potential for abuse when compared to a Schedule III or IV drug product. Could promote FDA to take enforcement actions against companies marketing CBD containing products as dietary supplements This could result in prolonged battle in federal court over legality of CBD in supplements

22 GW Pharmaceuticals Inches Closer to FDA Approval of CBD Medicine: Drug Approval Impact on CBD Supplements FDA has proclaimed CBD is excluded from the definition of dietary supplement under federal laws In part, it has been the subject of clinical trials by GW that have been made. However, the agency, hasn t moved in federal court to shut down the industry CBD in supplements will need to sufficiently distinguish their products and their constituents from Epidiolex Additionally what studies can substantiate the claims per FTC and state s consumer protection statutes? 9th Circuit no one commented so the courts, upheld DEA final rule Farm Bill?

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