Slide 1
Slide 2

Re: DEA Interpretive Rule Banning Hemp Foods & Hemp Oils

Posted on December 21, 2000

President Bill Clinton
Vice-President Al Gore
US Senator Barbara Boxer
US Senator Diane Feinstein
US Rep. Randy “Duke” Cunningham
Raymond Kelly, Cmmr., U.S. Customs
Jacob J. Lew, Dir., Office of Management and Budget
Lawrence H. Summers, Secy., Department of the Treasury
Norman Mineta, Secy., Department of Commerce

Douglas G. Waddel
Minister and Deputy Head of Mission
Canadian Embassy

The Honourable Allan Rock
Minister of Health Canada

Hugh Davis
Head, Microbiology and Cosmetics
Health Canada

Mr. Niels Hansen-Trip
Manager of Drugs Surveillance
Health Canada

Canada Senator Lorna Milne
Senate of Canada

Re: DEA Interpretive Rule Banning Hemp Foods/Oils

Dear Sir/Madam,

The Drug Enforcement Agency (DEA) has just published preliminary notification of three “Interim Rules” which will make organic THC a Schedule I Controlled Substance restricting products made from non-drug industrial hemp foods and oils and which will be effective immediately without public comment upon publication in the Federal Register (which is threatened to occur in the next 30 days). Enclosed is a copy of the Notice (part of the Unified Agenda, published in the Federal Register on November 30, 2000 (Volume 65, Number 231, Page 74025). The Notice proposes three new rules which the DEA deems “nonsignificant” but which are quite significant and which may constitute an unconstitutional taking:

New Rule #1: The DEA’s interpretive rule that existing law covers organic THC contrary to every decided case on this issue, the DEA has found this interpretation.

New Rule #2: The DEA intends to change Schedule I to add organic THC to the list of controlled substances to codify its interpretation set forth in New Rule #1.

New Rule #3: The DEA states “the interim rule will not allow ‘hemp’ products that result in THC entering the human body” and will exempt hemp fiber crops.

The Interim Rules are now being reviewed by other agencies. Please immediately contact these agencies asking for there to be usual rulemaking including a public hearing on these rules (contact information listed below): Raymond Kelly, Commissioner U.S. Customs; Jacob J. Lew, Director, Office of Management and Budget; Lawrence H. Summers, Secretary, Department of the Treasury; and Norman Mineta, Secretary, Department of Commerce.

Our company, Dr. Bronner’s Magic Soaps, uses over 30,000 lbs. of refined hemp oil and 2,000 lbs. of unrefined hemp oil a year in our soaps. The hemp oil’s essential fatty acids make our soaps much smoother and less drying, improving the afterfeel dramatically. We face immediate harm from the Interim Rules in having to re-formulate and re-label our soaps without hemp oil, and devastating long-term harm to our reputation and quality. We sell a bit over $6,000,000 annually of liquid and bar soaps into both the health food and mainstream marketplaces. If the Interim Rules are issued, we will suffer immediate damage without due process to make our case on the making of a law that will constitute a taking of our livelihood.

These Interim Rules would also override 63 years of settled law passed by Congress in 1937 and reinforced by the Courts in every case decided on this issue. Under settled law upon which thousands of US businesses and individuals, including Dr. Bronner’s Magic Soaps, have relied, the legal definition of the controlled substance “Marijuana” has contained a “hemp exclusion” under which the prohibited substance does not include “oil or cake made from the seeds of such plant, any other compound, manufacture, salt, derivative, mixture, or preparation of such mature stalks (except the resin extracted therefrom), fiber, oil, or cake, or the sterilized seed of such plant which is incapable of germination.” 21 U.S.C. §802(16).

ONDCP and DEA have long held an agenda to further restrict legitimate hemp products in the name of the US War on Drugs. US Attorney General Janet Reno recently wrote to ONDCP Director Gen. Barry McCaffrey that “We lack legal authority to prohibit importation of hemp products unless the definition of marijuana in Title 21 U.S.C. Section 802.16 (c) [the Controlled Substances Act] is changed to remove the hemp exclusion.” Nonetheless, the DEA and ONDCP have taken it upon themselves to reverse this Congressional hemp exclusion by making organic, naturally occurring THC a controlled substance even when it occurs in de minimus trace amounts (e.g., less than 10 ppm).

The DEA’s rationale seems based on, one, protecting the “public health” from supposed harm resulting from trace THC in hemp foods and bodycare, and, two, the DEA and ONDCP claim that this ban is necessary in the interests of the US War on Drugs because they believe that human ingestion of hemp food or oils would cause false positive drug test results to such a large extent that enforcement of drug laws would be compromised.

On Sept. 6, 1988, in regards to medically active cannabis with two to five thousand times the concentration of THC than is present at trace amounts in non-psychoactive hemp seed and oil, the DEA’s own Administrative Law Judge Francis Young concluded that high-THC cannabis was inappropriately scheduled and concluded as fact:

“In strict medical terms marijuana is far safer than many foods we commonly consume. For example, eating 10 raw potatoes can result in a toxic response. By comparison, it is physically impossible to eat enough marijuana to induce death… Marijuana in its natural form is one of the safest therapeutically active substances known to man. By any measure of rational analysis marijuana can be safely used within the supervised routine of medical care.” (see DEA Docket No. 86-22)

The DEA ignored its own Administrative Law Judge’s findings, and buried his ruling. Now they are attacking hemp seed and oil, which contains only trace amounts of THC (less than 10 parts per million), with no evidence of harm. We ask that you request the DEA to ask the Human Health Services (HHS), as they are supposed to, whether trace THC in hemp seed oil and seed indeed constitutes a significant threat to public health.

A study (enclosed) prepared by Gero Leson, PhD. and partially funded by the Canadian government demonstrates that it is extremely unlikely that a test-positive for marijuana would result from even copious daily consumption of hemp seed and oil at current industry standards of <10 ppm THC in hemp seed and oil (in 1997, before these standards were widely implemented, there was seed and oil from China on the U.S. market with a much higher concentration of THC). Dr. Leson is preparing an extension of this study covering lip and skin care products which contain hemp oil as an ingredient, which will conclusively show that a test-positive using body-care with hemp oil is impossible.

Accordingly, the motivating factor of preserving the integrity of the US drug testing system is overstated by DEA as the sale of hemp foods and oils which contain non-psychoactive trace amounts of organic THC do not and will not jeopardize the effectiveness of existing drug testing programs.

The poppy seed versus opium/narcotics provides perspective. Poppy flowers, of which there are dozens of varieties, are popular in backyard gardens. The species Papaver somniferum includes many varieties of poppies, only one of which, the “red scarlet” poppy, produces opium and derivative narcotics (such as heroin) from its pods which contain significant amounts of concentrated opiates (primarily morphine and codeine). While the DEA has targeted red scarlets, home gardeners continue to cultivate the other non-opium producing varieties of Papaver somniferum. The poppy seeds that are commonly consumed as a condiment in baked goods such as bagels, breads, muffins and cakes derive from one of these other non-opium varieties of Papaver somniferum, commonly called the “breadseed poppy.” As the trace opiate levels in poppy seeds are higher than the trace THC in hemp seed, eating poppy seeds can produce a false positive for narcotic use on a drug test at the 300 ppb cutoff for opiates in urine; however, government agencies and corporations have adapted by raising the threshold for a test-positive beyond the level of ambiguity (from 300 ppb to 2,000 ppb).

At current industry-standard cleaning of hemp seed to below 10 ppm THC, studies indicate it is extremely unlikely for a marijuana false-positive on a drug test through ingesting even copious daily quantities of hemp seed or oil, and whatever remaining ambiguity there is could be easily addressed by reference to the poppy seed false-positive solution.

Incidentally, the poppy analogy provides perspective on other traditional arguments the DEA uses to maintain hemp prohibition. Poppy seed bagels and flowers are enjoyed by children of all ages, yet children do not confuse poppy seeds and poppy flowers with smoking opium, nor do they perceive a “message” that opium is good. Home garden and breadseed variety poppy plants look similar to the opium producing red scarlet poppy, yet the DEA seems able to tell the difference. Concentrating the trace opiates in breadseed poppy seeds to an active level is theoretically possible at enormous cost, effort and inefficiency; however, the DEA has not attempted to ban non-opium variety poppies based on this highly speculative scenario. The condiment and home gardening markets for poppies are smaller than the potential markets for hemp, yet the DEA has not argued for banning non-opium poppy plants for lack of a large market. Finally, the DEA has not suggested that breadseed and home garden poppies are a threat to the controlled status of opium, in spite of the fact that these plants all share the same genus and species.

The government’s conscious denial of established customs and practices with respect to an analogous plant to Cannabis sativa, the drug versus non-drug varieties of Papaver somniferum, sabotages its own credibility while causing great harm to American businesses who incorporate hemp seed and oil into their products. Under Controlled Substances Act Sections 802(18), (19) and (20), a distinction is made between poppy opiates (the drug substance), opium poppy (the plant) and poppy straw. The definitions of opium poppy and poppy straw expressly exclude the poppy straw. To depart from this framework in the case of industrial hemp would provide an inconsistency on the DEA’s part which militates towards a finding of arbitrary and capricious agency action. A workable system would include separate definitions of high THC Drug Cannabis (>1% THC), non-drug Cannabis Hemp (plants), and Hemp Straw and non-germinating seeds/grain which would be treated identically to poppy seeds.

In attempting to make naturally occurring, organic THC a controlled substance in New Rule #1, the DEA will be going against every decided case regarding the organic-synthetic THC distinction which have uniformly held that naturally occurring THC is not a controlled substance under the definition of “tetrahydrocannabinols” or “THC.” See, e.g., Schedule I, 21 U.S.C. §812(c); 21 C.F.R. § 1308.11(d)(26); United States v. McMahon, 861 F.2d 8, 11 (1st Cir. 1988) (organic-synthetic THC distinction); United States v. Wuco, 535 F.2d 1200, 1202 (9th Cir. 1976). The DEA would now change years of caselaw with the stroke of a pen and an Interim Rule – on its own and without Congressional oversight or public input.

In addition, any such Interim Rule is completely unnecessary given that if the levels of organic THC occurring naturally in hemp foods and oils were psychoactive, such foods and oils would themselves be “controlled substance analogues” under Controlled Substances Act Section 802(32)(A). Therefore, since the Interim Rule would provide no additional regulatory support, its sole purpose must be to harass legitimate hemp businesses and their consumers.

The statutory hemp exclusion (established in 1937) enabled US individuals and businesses to legally purchase, use, and trade in sterilized hempseeds, hempseed oil, hempseed cake, hemp fiber and products made therefrom. Hemp food, oil and fiber products are now available throughout the US, Canada, EU and Asia amount to over $200,000,000 in annual world sales. These businesses have invested years and millions of dollars and have created thousands of jobs under the hemp exclusion, a large portion of which relates to hemp food, oils and bodycare. Since seed is at issue, the following focuses on seed and oil only.

The hemp seed, actually a tiny nut, is comprised of a hull and a meaty inner core. Most of the seed’s value is derived from either dehulling the whole seed and/or crushing it for oil, as the inner core is an excellent source of desirable fatty acids and proteins.

Hemp oil’s primary value is its high content of the two essential fatty acids (EFA’s) Omega-3 and Omega-6. Its balanced EFA ratio, which closely matches human nutritional requirements, makes hemp oil an ideal ingredient in a variety of food, supplement and personal care products. Encapsulated hemp seed oil supplements are found in natural foods markets, usually next to increasingly popular flax supplements. The value of hemp oil as a broad-range oil supplement is further enhanced by the presence of a rare fatty acid, gamma-linolenic acid (GLA), and is the primary reason people buy borage and evening primrose oil, which helps to treat such ailments as neurodermatitis, arthritis and PMS. Because it is more versatile, tastier and keeps better than other high EFA oils, hemp oil is also used as a culinary ingredient. Hemp oil may be used as one would use a fine olive oil- for sauces, flavorings, dressings, low-heat cooking and sautéing.

The EFA’s that make hemp oil so good to take internally also make it ideal as a topical ingredient for the skin in cosmetic formulations. The high EFA hemp oil soothes, restores and moisturizes skin better than any other plant based oil. Since the introduction of The Body Shop’s line of hemp based body lotion, hand cream, soap and lip conditioner to the global marketplace, demand for hemp oil has grown rapidly. Revlon plans to introduce a hemp oil based line at the end of this year. Alterna, Rachel Perry, Kiss My Face and Jason’s Natural Cosmetics have successful hair and skin care lines made with hemp seed oil.

Hemp meal, the seedcake remaining from the oil crush, contains a large fraction of protein, with a composition similar to that of soy. The market for high protein powders and flours for use in shakes, energy bars, baking preparations, etc. is well established. Hemp’s naturally nutty flavor complements the fruit, nut and chocolate ingredients normally used in these products.

The hulled hemp seed or hemp “nut” remains after the removal of its hull. It contains 30-35% protein and 35-40% EFA’s by weight. This superior nutritional profile makes it ideal for a wide range of food applications. Hulled hemp seeds resemble sesame seeds in appearance and are comparable to sunflower seeds in taste. They may be incorporated in baking or simply added to foods such as soups or salads. Hulled hemp seed blended in shakes or drink mixes is an excellent way to meet daily protein and EFA needs. Hemp nuts may be ground and turned into nut butter for spreads and sandwiches. Lightly toasting the nuts will release the oil’s fragrance and enhance the flavor of the nutmeat. In the U.S., research is being conducted to use hulled or whole hemp seeds in the production of “hemp milk” as an alternative to soy or rice based non-dairy milks, a category that is now the largest selling in the natural foods business.

Below are listed some of the bigger California food and cosmetic companies that we know besides ourselves who manufacture or sell hemp oil and seed products. All the manufacturers below will be seriously impacted through having to discontinue hemp lines they have recently spent much time, money and energy to bring to market and promote:

Manufacturers
Rachel Perry, Chatsworth
Earthly Body, Porter Ranch
Dr. Bronner’s Magic Soaps, Escondido
Crystal Corporation (Alterna, Matahari, SunHemp), Los Angeles
Nutiva Foods, Sebastopol
All Terrain, Vista
Red Rooster & Sense, San Francisco
Two Star Dog, San Francisco
Jason Natural Cosmetics, Culver City
Rella Good Cheese Company, Santa Rosa
Spectrum Naturals, Petaluma
Govinda’s Fitness Foods, San Diego

Contract Laboratories
Gar Laboratories, Riverside
Spa de Soleil, Van Nuys
Aware Products, Chatsworth
Levlad/Nature’s Gate, Chatsworth
Columbia Cosmetics, San Leandro
Classic Cosmetics, Chatsworth

Suppliers/Distributors
Atlas Corp., Culver City
Nature’s Best, Brea
Mountain People’s Warehouse, Auburn
Super Nutrition-West, Inc., Visalia
DD Chemco/Botanigenics, Northridge
Natural Oils International, Arleta
Charkit Corporation, Santa Fe Springs

Retailers
All GNC stores in California
All Vitamin World stores in California
All Jimbo’s in California
All Henry’s stores in California
All Body Shop stores in California
All Whole Foods markets in California
All Wild Oats markets in California
All Trader Joe’s Markets in California
All Ralph’s supermarkets in California

There are plenty more smaller operations and stores with concerns no less real. Eliminating the hemp exclusion as to hemp foods and oil products by Interim Rule without public hearings constitutes a taking without due process of law. Banning hemp seed and oil for human consumption would also indirectly affect not only Canadian farmers and suppliers who grow and process the hemp crops that are sold to makers of the foregoing products, but also US farmers who have been studying the prospects of industrial hemp as a possible high-value crop at a time when American farmers are facing terribly depressed prices for soybeans, corn and wheat. This will create a very major “chilling” effect on the development of legitimate hemp industry in the US. Furthermore, it flies in the face of the many states which support industrial hemp, as evidenced by the attached press release Pro Hemp Resolution Adopted by the National Conference of State Legislatures at Washington DC Meeting.

The DEA and ONDCP are attempting to pass the ban hemp foods and bodycare as an Interim Rule to avoid public comment because they are aware of the facts that: (1) hemp seeds and hemp oils available in the US are not psychoactive, are not harmful, and do not contain enough trace amounts of THC to trigger a false positive drug test; (2) hemp seeds and hemp oils are highly nutritious additives for both human and animal food; (3) hemp food and oils relate to a large and diverse number of individuals, businesses and environmental groups who are anxious to make public comments and submit evidence to counter the misunderstandings of DEA and ONDCP in connection with hemp foods and oils; and (4) there has never been a reported case of adverse health effects from ingesting hemp foods, oils or products containing non-psychoactive trace amounts of THC.

Any proposed regulations affecting any trade or consumption of hemp products should be subject to usual rulemaking procedures (including public hearings and the submission by interested parties of scientific studies and other evidence) under the Administrative Procedure Act.

This is particularly important because US companies that use hempseed, hempseed cake and/or oil in their products import such products from Canada or the EU under NAFTA and/or the WTO. In fact, hemp is specifically listed as an agricultural good under NAFTA. Trade lawyers have opined that a Zero THC Policy violates Article 7 of NAFTA and the Canadian Embassy has expressed its displeasure in writing to Gen. McCaffrey and DEA on this topic. As a regulatory pronouncement of the Zero THC Policy, the Interim Rule would clearly violate Article 7 of NAFTA as well because it constitutes a trade barrier without there being any scientific evidence of harmful effects.

Since hemp has demonstrated its practical and economic utility in promoting health and reducing the ecological harm caused by prevalent human activities, hemp must be given due consideration even in light of countervailing policy considerations. It is not responsible to ourselves or future generations to allow for hemp foods and oils to be banned under the guise of closing some alleged drug testing loophole or hysterical uninformed health concerns.

Thank you for your attention to this important environmental and economic issue.

Sincerely,

David Bronner
President
Dr. Bronner’s Magic Soaps

President Bill Clinton
1600 Pennsylvania Ave.
Washington, D.C. 20500
Fax: 202-456-2461

Vice-President Al Gore
1600 Pennsylvania Ave.
Washington, D.C. 20500
Fax: 202-456-2461

Senator Barbara Boxer
United States Senate
112 Hart Senate Office Building
Washington, DC 20510

Senator Barbara Boxer
United States Senate
600 B Street, Suite 2240
San Diego, CA 92101

Senator Diane Feinstein
United States Senate
331 Hart Senate Office Building
Washington, D.C. 20510

Senator Diane Feinstein
c/o Mike Richmond, District Director
750 “B” Street, Suite 1030
San Diego, CA 92101

Representative Randy “Duke” Cunningham
2238 Rayburn House Office Building
Washington, D.C. 20515-0551

Representative Randy “Duke” Cunningham
613 West Valley Parkway, Suite 320
Escondido, CA 92025

Raymond Kelly, Commissioner
U.S. Customs
1300 Pennsylvania Avenue NW
Washington DC 20229
Fax: 202-927-1380

Jacob J. Lew, Director
Office of Management and Budget
Old Executive Office Bldg.
Washington DC 20503
Fax: 202-395-1005

Lawrence H. Summers, Secretary
Department of the Treasury
Pennsylvania Avenue NW
Washington DC 20220
Fax: 202-622-2599

Norman Mineta, Secretary
Department of Commerce
Herbert Hoover Bldg.
Pennsylvania and Constitution Avenues NW, Washington DC 20230
Fax: 202-482-2741

Douglas G. Waddel
Minister and Deputy Head of Mission
Canadian Embassy
501 Pennsylvania Avenue N.W.
Washington, D.C. 20001

The Honourable Allan Rock
Minister of Health
House of Commons
Wellington Street
Ottawa, Ontario Canada K1A 0A6
Fax: 613-992-1273

Mr. Hugh Davis
Head, Microbiology and Cosmetics
Health Canada
Water Quality, Microbiology and Cosmetics Division
12th Floor Jeanne Mance Building, Tunney’s Pasture
Ottawa, Ontario Canada K1A 0L2
Fax: 613-952-2574

Mr. Niels Hansen-Trip
Manager of Drugs Surveillance
Therapeutic Products Programme
Finance Building
A.L. #0201D3, Tunney’s Pasture
Ottawa, Ontario, Canada K1A 1B9

Senator Lorna Milne
Senate of Canada
Ottawa, Ontario, Canada

open cc:
Ralph Nader, Public Citizen
Anita Roddick, The Body Shop
Interested Hemp Activists and Businesses

P.S. FOR CANADA ONLY (Mr. Douglas G. Waddel, The Honourable Allan Rock, Mr. Hugh Davis, Mr. Niels Hansen-Trip, Senator Lorna Milne)

As of this summer, Canadian Customs stopped letting our soaps with Canadian compliant and certified hemp oil into Canada. The Industrial Hemp Office at some point “legally interpreted” the Industrial Hemp Regulations to require finished batch testing of all imported hemp products, irregardless of the fact that there is no established protocols for testing water-based finished products that Health Canada approves, as well as the fact that we can provide the relevant Certificates of Analysis showing the hemp oil itself is in full compliance with Canadian regulations. However, we just discovered that Health Canada’s position before this year as laid out in Policy Issue Sheet #2 (evidently from the Therapeutic Products Programme) coincided with reason in only requiring that the hemp oil itself be tested and certified compliant for each batch of finished product, so long as accompanying documentation established that production did not increase the THC of the starting material (hemp oil) in any way. I enclose our original letter to Mr. Niels Hansen-Trip after our soaps were stopped by Canadian Customs, Mr. Hansen-Trip’s response, our position paper to our Canadian customers explaining why we had to pull hemp oil out of our soaps for the Canadian market, and finally a copy of Policy Issue Sheet #2.

At this crisis point of both the American and Canadian hemp industries with regards to the DEA, American manufacturers and hemp industry as a whole cannot afford to be hamstrung by Health Canada’s hemp import restrictions. They make no sense, and significant resources and energy of our organization have to be diverted in order to make special batches of soap without Canadian hemp oil for export to Canada. We ask that you direct the Industrial Hemp Office to immediately review their import policies, and make them coincide with reason, so we can resume shipment of our standard soaps with Canadian hemp oil.

David Bronner
Dr. Bronner’s Magic Soaps

Copyright © 2000, Dr. Bronner’s Magic Soaps. All rights reserved.