| --- |
| title: "House Oversight: Estate Documents (Nov 12) (HOUSE_OVERSIGHT_024712)" |
| source: "House Oversight: Estate Documents (Nov 12)" |
| sourceUrl: "https://www.justice.gov/epstein" |
| date: "2026-01-01" |
| category: "House Oversight" |
| eftaNumber: "HOUSE_OVERSIGHT_024712" |
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| parseTier: "external-legacy" |
| engine: "engine undisclosed (ep-nov-12.greg.technology mirror)" |
| externalSource: "greg-ep-nov-12" |
| externalLicense: "not granted" |
| externalCredit: "ep-nov-12.greg.technology" |
| externalUrl: "https://ep-nov-12.greg.technology" |
| --- |
| |
| ACKRELL |
| CAPITAL |
| Cannabis Investment Report | December 2017 |
| a dietary supplement but not represented for use as a conventional food or as a sole item of a meal or |
| the diet. A dietary supplement generally is deemed to be a food under the FD&C Act. |
| The FD&C Act does not require foods or food labels to be pre-approved by the FDA, but it does |
| give the FDA broad authority to regulate the safety of food and food labels and to prevent interstate |
| commerce in adulterated or misbranded food. Facilities engaged in manufacturing, processing, pack- |
| ing or holding food for consumption in the United States are required to be registered with the FDA. |
| The FD&C Act requires most foods to bear nutrition labeling and requires food labels that bear |
| nutrient content claims and certain health messages to comply with specific requirements. The FDA is |
| authorized to enforce safety and labeling regulations by conducting inspections, sampling, recalls and |
| seizures, and by pursuing injunctions and criminal prosecutions. |
| Cannabis-Based Foods and Dietary Supplements |
| The FDA has published guidance (most recently updated in August 2017) concluding that (i) the |
| FD&C Act does not permit foods to which THC or CBD have been added to be sold in interstate |
| commerce and (ii) any product containing THC or CBD is not a dietary supplement. For this conclu- |
| sion to be legally correct, based on the FD&C Act provisions cited by the FDA, it would need to be |
| demonstrated that neither THC nor CBD were marketed in or as a food or as a dietary supplement |
| before the occurrence of certain approvals and clinical investigations of drugs that include THC (e.g., |
| Marinol) or CBD (e.g., Sativex or Epidiolex). The FDA publication does not demonstrate that neither |
| THC nor CBD were marketed in or as a food or as a dietary supplement before such occurrences and |
| merely states that the FDA is "not aware of any evidence that would call into question" its conclusion. |
| The FDA's conclusion has not been subject to any legal challenge, and it remains unresolved whether |
| certain cannabis-based products, particularly hemp-derived CBD products, might be regulated by the |
| FDA as foods or dietary supplements rather than as drugs. |
| FDA Policy and Enforcement |
| In December 2016, the FDA published a document titled Botanical Drug Development; Guidance for |
| Industry that discusses several areas in which, due to the unique nature of botanical drugs, the FDA |
| believes it is appropriate to apply regulatory policies that differ from those applied to nonbotanical |
| drugs. The guidance discusses challenges inherent to botanical drugs, including challenges related to |
| ensuring therapeutic consistency, and suggests certain steps to address those challenges. The guidance |
| was published only months after the DEA announced a new policy designed to increase the number |
| of DEA-registered cannabis cultivators and permit-registered cultivators to grow cannabis for privately |
| funded commercial drug development projects. These parallel developments indicate to some that the |
| federal government is opening a pathway to federal approval of cannabis-derived drugs. |
| The FDA has the legal authority under the FD&C Act and related regulations to significantly dis- |
| rupt the state-legal cannabis industry in the United States. The FDA has issued warning letters during |
| the past several years to distributors of hemp-based CBD products but has not broadly enforced fed- |
| eral law against the cannabis industry. A cannabis-focused publication on the FDA website states that |
| in deciding whether to initiate federal enforcement, the FDA may consult with its federal and state |
| 76 |
| © 2017 Ackrell Capital, LLC | Member FINRA / SIPC |
| HOUSE_OVERSIGHT_024712 |
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