These are only some of the factors a Best Practices company importing primary hempseed products (shelled hempseed, hempseed oil, whole hempseed, hempseed fines) to the United States must consider.
Regulatory issues have had far less negative impact on the primary hempseed product market in the U.S. than competitive ones. Historically there have been few problems with importing hempseed into the U.S.
The most notable was Kenex's 9 August 1999 paperwork issue, and the lack of a licensed hempseed sterilizer for several months when ETO was pressured by DEA to stop.
Hempseed shipments are usually tested for viability and THC. It is routinely held for 3 weeks under detention in a bonded warehouse to perform the tests. This is not the same as a shipment seizure, which have been very rare for hempseed shipments. As a matter of fact, I have imported more hempseed food than any over the past ten years, and I've never had any problems from any agency. So much for a "hemp embargo."
Despite still being available from other companies, in the Year 2000 whole hempseed was reformulated out of U.S. bird seed mixes, the loss of an easy market of 3,000 tons per year. Perhaps it was the negative publicity surrounding the Kenex incident blaming DEA and Customs, or perhaps the fact that Kenex's seized load was destined for a bird seed company.
Luckily, shelled hempseed filled the gap in the food market, since it is inherently non-viable, and thus compliant with the noxious weed act without needing to be sterilezed at a certified sterilizer. (However, no federal agency has recognized shelled hempseed in any form or term, and there is no standard of identity for it.)
Since any trace THC adheres to the outside of the shell, which is removed and discarded, shelled hempseed is exempt from the CSA of 1970 as "zero THC" when measured per "Customs Method USCL FO-03 (11.7) of 8/2000 for testing of tetrahydrocannabinols." The maximum detection limit of the method is one part-per-million. If not, get a new sheller.
As you can see, if you import hempseed products fixation on DEA is unjustified, as it is only one very small step down a very, very long road. DEA is almost the least of one's problems, as hempseed foods properly made are exempt from DEA regulation anyway, being "zero THC." Far greater issues are the press, drug test interference, and conservative market channels.
How well "the industry" deals with DEA will show how much (or little) credibility and ease it will have later with the other alphabet-soup of agencies, any one of which can stop hemp foods cold, legally, completely, and with no public comment period. Celebrate successes now, but remember that the battle is long and hard. One battle does not make a war.
Explanations of the above web of a labyrintine maze:
Customs: U.S. Customs and Border Protection (formerly US Customs Service, now under Dep't of Homeland Security) inspects every shipment into the U.S., and since hemp is not grown in the U.S. every hemp shipment and its paperwork passes through a US Customs Inspector's hands. Enforces more than 400 laws, including USDA and FDA regulations, CSA of 1970, DEA Rule of 2001, Admin. Rules, FD&C Act, and collects duties and enforces tariffs. Customs is the gatekeeper for all hemp products.
CSA of 1970: Controlled Substances Act of 1970, prohibits Cannabis or THC without a DEA permit, and of which DEA made no exemptions or waivers until its unprecedented Interpretive Rule of 2001 allowing THC on non-food hemp. Last permit issued in 1994 to Hempstead in California. Admission in any way that a product of any kind contains any amount of THC greater than "zero" is violating this law, and export documents are legal documents required by law to be true. Hence, if a company insists on the wording "Contains <10 ppm THC"on its export documents to the U.S., it could be reasonably assured of trouble. One such occurence was on 9 August, 1999 when US Customs, in consultation with DEA, seized a load of various hemp products from Kenex of Ontario Canada due to"documents admitting they were importing a controlled substance,"as a Customs employee would reasonably conclude. Since properly-made hemp foods are exempt from the CSA of 1970 as they are"zero THC,"more serious exposure in the medium-to-long run is with FDA, since THC is not GRAS and the food might be considered a THC delivery system or medical device.
DEA Rule: DEA's Interpretive Rule of March 2003 officially permits THC on hemp imports not for human ingestion, which account for 90-95% of the "hemp industry." Since properly made hemp foods are zero THC, this "get out of jail free card" for hemp that has THC on or in it was a rare show of common-sense and change to policy by DEA, and was a collective relief of hemp fiber and textile importers. Would also cause now-banned, non-THC hemp-containing alcohol to be marketed again. See 21 CFR 1308.
Admin. Rules: Federal agencies can make "Administrative Rules" which have the force of law, until and if invalidated by a federal court. DEA Rule above is an example.
Noxious weed act: Customs enforces fumigation and sterilization requirements for certain plants and plant products. USDA's federal Noxious Weed Act of 1974 (and some states) have laws prohibiting the seeds of plants considered "noxious," of which hemp is one due to the ability to grow fast and far. This is why hempseed in the US must be sterilized (made unable to grow). See 7 USC 2801-2813.
F.T.C.: U.S. Federal Trade Commission, regulates packaging, advertising claims and trade, per Fair Packaging and Labeling Act. See 15 USC 1451.
B.A.T.F.: Bureau of Alcohol, Tobacco, and Firearms regulates alcohol sales and labels, each state also has one. Has prohibited hemp-containing wine, beer, and spirits, citing CSA of 1970. In April 2000 agreed to abide by DEA's final Interpretive Rule.
F.D.A.: U.S. Food and Drug Administration, regulates foods, drugs, and medical devices. Enforces GRAS, DSHEA, NLEA, FD&C and other Acts. labels, health claims, and medical devices. Each state's health department also regulates the above laws and regulations, and inspects food production and storage facilities and issues permits. Requires standard of diligence for food processors, including Good Manufacturing Practice (GMP), Hazard Analysis and Critical Control Point (HACCP), and the Bioterrorism Act of 2002.
GRAS: Generally Recognized As Safe, the requirement for any food ingredient, or direct or "indirect" additive. FDA currently does not consider primary hempseed, hempseed products or hempseed oil to be GRAS, thus the secondary products containing it will not be GRAS. See 21 CFR 170.
DSHEA: Dietary Supplement Health and Education Act of 1994, established a new regulatory definition for "dietary supplement:" a product (other than tobacco), intended to supplement the diet, that contains one or more dietary ingredients, including vitamins, minerals, nutraceuticals (such as high omega-3 shelled hempseed and hempseed oil), herbs, use to supplement the diet by increasing the total dietary intake. Dietary supplements are intended for ingestion in capsule, powder, tablet, softgel, or gelcap and liquid form (as in the case of hempseed oil). Dietary supplements must be labeled as such.
NLEA: Nutrition Label and Education Act of 1990 regulates health claims for foods, such as structure/function claims, and disease and health claims on labels, ads, and sales materials. See 21 CFR 101.
FD&C Act: Federal Food, Drug and Cosmetic Act prohibits deceptive practices and regulates the manufacture, sale and importation or exportation of food, drugs and cosmetics. Customs enforces the regulations of Health and Human Services and Treasury by regulating the importation of the foregoing products and/or their exportation. See 21 USC 301-394; 19 CFR 12 (1995); 21 CFR 1.83-1.99 (1995). See also Memo Of Understanding between FDA and Customs, October 1, 1980.
Medical device: Any THC delivery system must be tested and approved, which might include a food if it contained THC.
THC: Tetrahydrocannabinol, the trace molecule on the outside of the hempseed shell which might cause drug test interference, or an alleged positive drug test.
State Attorneys General: Each state also enforces state and federal laws and regulations. Some are very conservative and highly political at "protecting" its citizens, and all campaign for election.
Press: Today's press is looking for more provocative stories at every turn. "If it bleeds, it leads" applies to print also. Lax at checking facts, frequently libels, rarely corrects. Too influential relative to its propensity to be manipulated and degradation of standards.
Product liability insurers: Every Distributor and Retailer requires proof of product liability insurance from every vendor, to sell products for human ingestion. Insurers pay claims for damages allegedly due to drug test interference. No insurance=no business, because they'll be the "deep pockets" on the hook.
D.E.A.: Drug Enforcement Administration, regulates Controlled Substances, issues permits to grow hemp, last permit was issued in 1994 in Brawley, to Hempsetad of Costa Mesa California.
U.S.D.A.: U.S. Department of Agriculture regulates seed import and standards and pests, is the legitimate regulator of industrial hemp imports and cultivation, as it was for the 161 years from 1776 until hemp policy became politicized with the federal Marijuana Tax Act of 1937, and later the CSA of 1970. USDA reports were generally effusive about that year's hemp crop. Approx. 500,000 acres still grow annually in America's heartland (ditch weed), dwarfing hemp production in every country except China, and 25 time more than Canada. Hemp and hempseed cultivation and trade are exempt explicity in international drug treaties, and the EU subsidizes it.
Distribution channel: The Distributors generally decide what is allowed to be sold to the retail channel by approving and delivering products. Economies of scale require this partner in most food retailing schemes. May have as many as 80,000 different items for sale. Now dominated by large, public firms, risk-averse and very conservative with which products they support to bring to market, since the stakes, and costs, are so high.
Retail channel: The retail stores which stock products sold to them, usually by Distributors. Also now dominated by large, public firms, risk-averse and very conservative in the market and image, including many natural food stores.
Drug test interference: The possibility alleged by some people facing dire personal consequences for failing a drug test, that trace THC on the outside of hempseed shells caused their positive urine test for marijuana. The reason for DEA's objection to hemp ingestion. A $6 Billion industry, with little accountability. Some 2 million are drug tested in the US, and its use is expanding. Theory has yet to be proven or disproven. Nevertheless, the ambiguity resulted in a ban on the consumption of hemp foods and oil by the those in the military, and law enforcement, and some unions.
Consumer: The ultimate reason all the above exists. The final user of the product, the retailer's customer. "Biological Proximity" dictates more concern about safety of food than body care and clothes. Can often be very fickle, contradictory, litigious.
Zero THC: In the land of zero tolerance, a purely political construct wherein "zero THC" means "1 part-per-million THC." This is the detection cut-off of Customs' "Method USCL FO-03 (11.7) of 8/2000 for testing of tetrahydrocannabinols."
Source: Hemp Food Association, www.hempfood.com. Personal opinion of and Copyright by Richard Rose 2004, all rights reserved. For informational purposes only, not the practice of law. I am not an attorney, so consult one before reliance upon the above. I am not liable for any errors or omissions, nor nocturnal submissions. I will, however, consult with you if you still have questions.
Click here and see that leading hempseed experts agree: "Hempseed can be cleaned free of THC."
Click here for DEA's position.
Click here for the Interpretive Rule as it appears in the Federal Register.
Click here to see that we foresaw the importance of this issue 10 years ago in 1994.
Click here to see our release dated 8 Feb 1999 on usenet where we said that hempseed foods can easily and cheaply be cleaned to have no detectable THC, or "zero THC," in an attempt to encourage the newer companies to do the same.
So what is the reason for this new interest by the DEA in hempseed products? Over the past few years many hundreds of people failed a drug test and wrongly blamed hempseed products, hoping to be excused. While one can understand such desperation to avoid jail or losing a job, the drug testing industry became quite alarmed at what they termed the "drug test interference" defense raised by these folks and their lawyers. So DEA responded by banning THC in hempseed products.
This issue highlights the need for federal deregulation of drug-free industrial hemp. It is an issue of states' rights, farmers' freedom, and makes good business sense. Industrial hemp is not a drug therefore the federal government should not have a compelling interest in regulating industrial hemp. Regulation of alcohol was gigven to the states after prohibition, the same model could be applied to hemp cultivation.
Using the square peg of science on the round circle of politics costs much in legal fees, and is rarely anything but a failure. The continued restrictive scheduling of Cannabis in the US is but the most glaring example: if science could actually rule politics, marijuana and vaporizers would have been available in every liquor store in the land years ago. But instead doctors and the sick and dying are locked up like criminals by the same cynicism that makes untrained street police replace physicians when it comes to medicine, and calls it science.
(We're not just any ole Hemp Nut, we're THE Hemp Nut, the popularizers of shelled hempseed in North America.)
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