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Guidance on California Proposition 65 and Hemp ProductsWARNING: Consuming this product can expose you to chemicals including [name of one or morechemicals], which is [are] known to the State of California to cause cancer and birth defects or otherreproductive harm. For more information go to www.P65Warnings.ca.gov/food.Where any of the warnings above is being provided for an exposure to a single chemical, the words“chemicals including” may be deleted from the warning above, but in that circumstance the warning willonly cover the identified chemical.Where the warnings above are provided on a food or dietary supplement product label, the warningmust be set off from other surrounding information and enclosed in a box.Consumer product warningsFor hemp products that are not consumed, such as personal care products, the general consumerproduct safe harbor warning language may be used: For any chemical listed as a carcinogen:WARNING: This product can expose you to chemicals including [name of one or morechemicals], which is [are] known to the State of California to cause cancer. For more information goto www.P65Warnings.ca.gov. For any chemical listed as a reproductive toxicant:WARNING: This product can expose you to chemicals including [name of one or morechemicals], which is [are] known to the State of California to cause birth defects or otherreproductive harm. For more information go to www.P65Warnings.ca.gov. For a chemical listed as a carcinogen and a different chemical listed as a reproductive toxicant:WARNING: This product can expose you to chemicals including [name of one or morechemicals], which is [are] known to the State of California to cause cancer, and [name of one ormore chemicals], which is [are] known to the State of California to cause birth defects or otherreproductive harm. For more information go to www.P65Warnings.ca.gov. For any chemical listed as both a carcinogen and as a reproductive toxicant:WARNING: This product can expose you to chemicals including [name of one or morechemicals], which is [are] known to the State of California to cause cancer and birth defects or otherreproductive harm. For more information go to www.P65Warnings.ca.gov.Where any of the warnings above is being provided for an exposure to a single chemical, the words“chemicals including” may be deleted from the warning above, but in that circumstance the warning willonly cover the identified chemical. AHPA October 20214

Guidance on California Proposition 65 and Hemp ProductsCompanies can also comply with the warning regulation using the short-form warning option. Thiswarning option contains a symbol consisting of a black exclamation point in a yellow equilateral trianglewith a bold black outline4 placed to the left of the warning text, as well as the following: For consumer products that cause exposures to a listed carcinogen:WARNING: Cancer - www.P65Warnings.ca.gov.For consumer products that cause exposures to a listed reproductive toxicant:WARNING: Reproductive Harm - www.P65Warnings.ca.gov.For consumer products that cause exposures to both a listed carcinogen and a reproductivetoxicant:WARNING: Cancer and Reproductive Harm - www.P65Warnings.ca.gov.For short-form warnings, the warning language must be no smaller than the largest type size used forother consumer information5 on the product, and in no case shall the warning appear in a type sizesmaller than 6-point type. Short-form warnings are not required to include the name or names of alisted chemical within the text of the warning.Warnings provided by the product retailerThe manufacturer, producer, packager, importer, supplier, or distributor of a product may also complywith the Proposition 65 warning requirements by providing a written notice directly to the authorizedagent for every retail seller of the product in the State of California, which includes all of the following:1. States that the product may result in an exposure to one or more Proposition 65 listedchemicals;2. Includes the exact name or description of the product or specific identifying information for theproduct such as a Universal Product Code (UPC) or other identifying designation;3. Includes all necessary warning materials such as labels, labeling, shelf signs or tags, and warninglanguage for products sold on the Internet;4. Has been sent to the retail seller, and the manufacturer, producer, packager, importer, supplier,or distributor has obtained confirmation electronically or in writing of receipt of the notice.The product retailer is directly responsible for providing Proposition 65 warnings to consumers undercertain other circumstances, such as when the retailer knowingly introduces a listed chemical into theproduct, or when the retailer obscures a warning label that has already been affixed to the product.4If the sign, label, or shelf tag for the product is not printed using the color yellow, the symbol may be provided inblack and white. The warning symbol can be downloaded from the OEHHA website.5 “Consumer information” includes warnings, directions for use, ingredient lists, and nutritional information.“Consumer information” does not include the brand name, product name, company name, location ofmanufacture, or product advertising. AHPA October 20215

Guidance on California Proposition 65 and Hemp ProductsWhich chemicals require warnings under Proposition 65?Proposition 65 requires the State of California to publish and maintain a list of chemicals known to causecancer or reproductive toxicity. The list is updated periodically; the most recent list is accessible on theOEHHA website.6Chemicals can be added (or occasionally removed) from the list by various mechanisms, such as adeclaration by an authoritative body or by scientific testing.Of interest to any company that sells herbal products such as those derived from hemp, or anyconsumer product manufactured from plants for that matter, are certain heavy metals. Metals such asarsenic, cadmium, lead and mercury are found in soils all over the world, both in naturally occurringamounts and in some cases as a result of human activity over the centuries. Each of these metals is onthe current Proposition 65 list as reproductive toxins, i.e., as chemicals capable of causing birth defectsor other reproductive harm if consumed in sufficient quantity. In addition, arsenic and lead are listed ascarcinogens by oral ingestion and cadmium is listed as a carcinogen by inhalation.Of these four heavy metals, it is lead that requires the most attention for botanical ingredients such asthose derived from hemp. Lead is found almost everywhere in the environment, both as a result ofnatural processes and sometimes as a byproduct of the use of fossil fuels, lead-containing agriculturalchemicals, and leaded brass implements for harvesting, processing, or irrigating plants. As with otherheavy metals, lead is readily absorbed into the tissues of many plants. And the level of lead that requiresa warning (see below) is exceptionally low.With the addition of Δ9 THC to the Proposition 65 list on January 3, 2020, hemp companies have a oneyear compliance period until January 3, 2021 to implement Proposition 65 warnings, if required, for anyproducts marketed in California. Subsequent to this date, and in the absence of OEHHA setting aMaximum Daily Allowable Level (MADL) safe harbor value for Δ9 THC, it is possible that some marketersof hemp products containing detectable amounts of Δ9 THC may need to provide a compliantProposition 65 warning. The listing of Δ9 THC under Proposition 65 is not limited to specific routes ofexposure, so a warning for potential exposure to Δ9 THC may be needed for products that are consumedorally, topically, or that are inhaled.Other listed chemicals of interest to hemp companies include the terpene β-myrcene, which is aconstituent of hemp plants, and pesticides such as myclobutanil and carbaryl, for which some cannabisbusinesses have received Proposition 65 notices.How much exposure to a chemical triggers a warning?Proposition 65 mandated warnings are not required when a product presents exposure to listedchemicals below certain levels. For carcinogens, this level is one that “poses no significant risk assuminglifetime exposure at the level in question.” Said another way, and according to OEHHA:6OEHHA revises this document on a regular basis. Please see the following url for access to the mostrecent version - -list. AHPA October 20216

Guidance on California Proposition 65 and Hemp ProductsFor a chemical that is listed as a carcinogen, the “no significant risk” level is defined as the levelwhich is calculated to result in not more than one excess case of cancer in 100,000 individualsexposed over a 70-year lifetime. In other words, if you are exposed to the chemical in question atthis level every day for 70 years, theoretically it will increase your chances of getting cancer byno more than 1 case in 100,000 individuals so exposed.For reproductive toxicants the level below which a warning is not required is that which “will have noobservable effect assuming exposure at one thousand (1000) times the level in question.” According toOEHHA:For chemicals that are on the list as reproductive toxicants, the no significant risk level is definedas the level of exposure which, even if multiplied by 1,000, will not produce birth defects or otherreproductive harm. That is, the level of exposure is below the “no observable effect level (NOEL),”divided by 1,000. (The “no observable effect level” is the highest dose level which has not beenassociated with an observable reproductive harm in humans or test animals.)Who is responsible for all of this? Who is liable?The law states that “No person in the course of doing business shall knowingly and intentionally exposean individual to a chemical known to the state to cause cancer or reproductive toxicity without firstgiving clear and reasonable warning to such individual” -- unless a defense to the warning requirementapplies. This “person” can be any company in the stream of commerce, e.g., a manufacturer, distributoror retailer. Enforcement is most often against the manufacturer of a product, but there have been casesbrought against retailers.Companies with fewer than ten employees are exempt from the requirements to provide warningsunder Proposition 65. However, both the California Attorney General and private enforcers have takenthe position that Proposition 65 liability applies to any company with ten or more employees that is inthe stream of commerce for the product. In this view, a manufacturer with fewer than ten employeeswould not be liable under Proposition 65, but its distributors and retailers, assuming they each have atleast ten employees, could be liable. As a result of common indemnity practices and business customs,therefore, the small manufacturer may still be asked to take financial responsibility for compliance by ora lawsuit against the larger distributor or retailer.How is Proposition 65 enforced?This law is enforced by civil suits against companies that are alleged to be in violation of itsrequirements. The State Attorney General and local district and city attorneys have authority to takesuch actions, but, unlike most of the laws in the State of California, such a suit may also be brought by“any person in the public interest.” Almost all of the cases that have been brought against herbalproducts companies to date have, in fact, been the result of actions by private plaintiffs outside ofgovernment offices.An action against a company by a private plaintiff will be initiated by a “60-day Notice.” In this Noticethe company is informed that the plaintiff claims violations of Proposition 65 and intends to bringenforcement action against the company within 60 days unless the Attorney General has first begun toprosecute the company for the alleged violations. AHPA October 20217

Guidance on California Proposition 65 and Hemp ProductsThe violations described in the cases involving herbal companies have been based on allegations by theplaintiffs that, although the company’s products do not bear Proposition 65 warning labels, there areone or more listed chemicals in the company’s products at levels that in fact require warnings. In severalcases the Notices have attached an Appendix that lists the company’s entire product line.Proposition 65 generally places the burden of proof on the defendant. Once a company has received a60-day Notice, the company will be required to defend against the alleged violation. A company mayalso be called upon to prove that its customers actually use their products in the amounts specified onthe labels. Furthermore, although the law specifies that exposure be made “knowingly andintentionally,” these terms as they are usually understood typically have not proven to be a practicalimpediment to enforcers in the past.The law specifies that civil liability in a Proposition 65 action “shall not exceed 2,500 per day for eachviolation.” The Proposition 65 statute does not define what constitutes a “violation.” Plaintiffs typicallyargue that a violation occurs each time that each consumer consumes a daily serving of a product, suchthat a broadly sold product can be argued to represent a large number of violations each day. In the fewcases that have gone to trial where a court is determining the civil penalty, the courts generally haveviewed each violation as each unit sale to a consumer in California without a required warning duringthe relevant period. As stated at the outset, payments and attorney fees of up to 682,000 have beenlevied against some manufacturers of herbal dietary supplement products whose products were allegedto contain heavy metals in amounts that were in excess of the established “safe harbor” levels.What should a company do if it gets a 60-day notice?The defense of a lawsuit brought under California Proposition 65 is a complex process requiring specialexpertise. It is strongly advised that anyone in receipt of a 60-day Notice contact an attorney who isknowledgeable about this law. AHPA maintains communications with several legal firms who specializein environmental and consumer law and can sometimes provide an introduction.How can a company doing business in California bestdeal with Proposition 65?The best advice would appear to be simple: know your products. That said, companies should be awarethat any testing they perform may be discoverable by prosecutors and therefore used against them, solegal advice should be sought on these issues.Articles have been published in scientific journals that have recorded laboratory analyses of heavymetals in herbal products at levels that may require warnings under Proposition 65, depending onserving sizes, naturally occurring levels, and other factors. At this time there are also the existing casesand settlements that have occurred in the past several years. Any company selling herbal products suchas those derived from hemp should be prepared to answer any charges that are brought against them inthis matter promptly, as the burden of proof is on the company. AHPA October 20218

Guidance on California Proposition 65 and Hemp ProductsChemical testing under Proposition 65Are specific levels established for these chemicals?The burden of showing that an exposure is below the threshold levels is on the company that “exposes”the consumer to a product. OEHHA has, however, established “safe harbors” for many chemicals on theState’s lists, including most of the heavy metals that may be of interest to marketers of hemp-derivedproducts. These levels are stated as “no significant risk levels” (NSRL) for chemicals listed as carcinogensand as “maximum allowable daily levels” (MADL) for chemicals listed as reproductive toxins. OEHHA hasadopted “safe harbor” NSRLs and MADLs for about half of the over 900 chemicals listed underProposition 65. If OEHHA has not published a safe harbor NSRL or MADL for a chemical, the burden fallsto a defendant in litigation to prove the right NSRL or MADL for the chemical.Heavy metalsNSRL and MADL levels for arsenic, cadmium, lead and mercury are given in Table 1. All quantities arethose that are given in OEHHA’s publication of March 2019, Proposition 65 No Significant Risk Levels(NSRLs) for Carcinogens and Maximum Allowable Dose Levels (MADLs) for Chemicals CausingReproductive Toxicity7 unless otherwise stated.Table 1 – Current “safe harbor” levels of relevant heavy metalsCarcinogenReproductive toxicantNSRL ( g/day)MADL ( g/day)arsenic a10 bnone established ccadmium0.05 (inh) d4.1150.5none established fnone established gleadmercury eabcThe specific listed carcinogenic chemical is “arsenic (inorganic arsenic compounds);” that listed as adevelopmental toxin is “arsenic (inorganic oxides).”Limit for inhaled arsenic is 0.06 g/day; the level given here is the limit for exposure by other routes,e.g., ingestion, and is given for the specific listed chemical “arsenic (inorganic arsenic compounds)”.“Arsenic (inorganic oxides)” is listed in the September 2012 publication8 as a “second priority” forestablishment of a MADL. In October 2007 this chemical was listed as a “first priority,” and a “draft oralMADL” of 0.1 g/day was published by OEHHA in 2003. At least one settlement from July 2008establishes a limit of 10 µg/day as total arsenic.97See the following link for the latest list of safe harbor levels: rls-maximum. Accessed on April 24, 2019.8 Priority List for the Development of Proposition 65 Safe Harbor Levels. OEHHA, September 2012 Update.9 One such example settlement is found in Steven D. Gillett v. Madison One Acme Inc., a Company doing business a

this information does so as its own choice; is wholly responsible for any policies established . Proposition 65 warnings are typically provided by the manufacturer, producer, packager, importer, . such as