Intervention Model for Contaminated Consumer Products: A Multifaceted Tool for Protecting Public Health

Abstract

Lead-based paint and occupational lead hazards remain the primary exposure sources of lead in New York City (NYC) children and men, respectively. Lead poisoning has also been associated with the use of certain consumer products in NYC.

The NYC Department of Health and Mental Hygiene developed the Intervention Model for Contaminated Consumer Products, a comprehensive approach to identify and reduce exposure to lead and other hazards in consumer products. The model identifies hazardous consumer products, determines their availability in NYC, enforces on these products, and provides risk communication and public education.

Implementation of the model has resulted in removal of thousands of contaminated products from local businesses and continues to raise awareness of these hazardous products.

Although lead poisoning has declined dramatically in New York City (NYC) and across the United States, lead poisonings continue to occur.¹ In NYC, most identified cases of lead poisoning are among young children, pregnant women, and occupationally exposed adults. The primary exposure source for lead in NYC children remains lead-based paint from older, poorly maintained homes. However, in 2009, 24% of the lead-poisoned children interviewed by the New York City (NYC) Department of Health and Mental Hygiene (DOHMH) did not have an identified lead-based paint hazard. During the same year, 15% of men and 89% of women reported potential nonoccupational sources of lead exposure. Examples of such sources include consumer products containing lead, such as certain spices, cosmetics, supplements or remedies, and glazed ceramic foodware.^1–6

NYC is a highly heterogeneous city; its residents come from a broad spectrum of ethnic, cultural, and religious backgrounds. Many residents maintain close ties with their birth and ancestral countries and exchange goods through the domestic marketplace, travel, and contacts abroad. Some of these imported goods may contain lead or other heavy metals at levels exceeding reference limits. Lead may be intentionally added to certain products (e.g., for perceived therapeutic benefits, as a coloring agent, to add weight to products sold by weight), or inadvertently added along the supply chain (e.g., lead contamination of soil where raw ingredients are grown, poor processing equipment).

The NYC Health Code defines lead poisoning as a blood lead level (BLL) of 10 micrograms per deciliter or higher. Effects in adults can include increased risk of hypertension, kidney disease, cognitive dysfunction, and reproductive risks.⁷ Lead poisoning in children can affect neurocognitive development and result in learning and behavior problems.⁸ Adverse health effects may occur even at BLLs lower than 10 micrograms per deciliter.^9,10 Preventing lead exposure is the only effective way to protect adults and children from lead poisoning.

INTERVENTION MODEL FOR CONTAMINATED CONSUMER PRODUCTS

A comprehensive approach to identify and reduce exposure to lead in contaminated consumer products was needed as lead poisoning cases associated with these products became more commonly recognized. The NYC DOHMH Intervention Model for Contaminated Consumer Products, which evolved during the course of several investigations, expanded the health department’s ability to respond to and prevent lead poisoning from these sources (Figure 1). The model has 4 components: identification of hazardous consumer products, determination of product availability in NYC, embargo and enforcement, and risk communication and public education.

FIGURE 1—

Intervention model for contaminated consumer products in New York City (NYC).

Identification of Hazardous Consumer Products

The model starts with the identification of potential lead sources. Lead sources are primarily identified during investigations of lead poisoned individuals. DOHMH receives the results of all blood lead tests for NYC residents. In 2009, DOHMH received blood lead tests results for more than 300 000 children and 90 000 adults.¹ Environmental interventions are offered to families with children younger than 6 years with BLLs of 10 micrograms per deciliter or higher. Case coordination and environmental investigations are provided for families with children up to 18 years of age with BLLs of 15 micrograms per deciliter or higher. Adults with BLLs of 10 micrograms per deciliter or higher are interviewed to identify potential exposure sources, and follow-up investigations are initiated as warranted. During investigations of child and adult lead poisoning cases, DOHMH uses a detailed risk assessment questionnaire to identify potential lead sources (example questionnaires can be found as data available as a supplement to the online version of this article at http://www.ajph.org). The questionnaire collects information on demographic characteristics, medical history, and risk factors for lead poisoning (e.g., lead paint hazards, occupation, hobbies, pica behavior, recent travel history, and use of imported products). Samples of products suspected to contain lead, and which may be mouthed or ingested, are collected and sent for laboratory testing. Information about each sample, including a description of the product, amount used, frequency of use, brand name, manufacturer, distributor, and purchase source, is documented along with a digital photograph of the sample. For children, a thorough environmental inspection in residential, daycare, or educational units where the child spends a considerable amount of time is also conducted to identify presence of lead-based paint hazards. Standardized sample collection protocols not only gather critical information for each investigation, but also allow for the monitoring of trends and the documenting of information needed for enforcement actions.

Identifying a lead exposure source in a case investigation can be difficult. It relies on the exchange of information between the individual or individual’s family and DOHMH staff. Culturally sensitive, nonjudgmental interviewers are critical for gaining the trust of the individual (or individual’s family) and obtaining valuable information. Language and cultural barriers, anxiety toward government, stigma associated with the use of certain products, and fear of “getting someone in trouble” may hinder exchange between DOHMH staff and the individual. Individuals may also not consider an item a risk factor, and hence, may not report using it. Miscommunication can occur if a product has multiple names or uses. Familiarity with terms used to reference a product and asking questions in multiple ways helps extract the information. For example, during one investigation, a parent of a lead-poisoned child initially stated the child did not wear any jewelry. However, after further probing, the parent said the child wore an amulet or “something to protect him.” The amulet was found to contain 45% lead.¹¹ Without appropriate and adequate probing, a potential lead hazard can remain unidentified.

DOHMH implements the model for any product obtained in the United States and associated with a lead poisoning case. The model may also be initiated when products obtained abroad are associated with multiple poisonings. In such cases, DOHMH visits local businesses to identify availability of these and similar products. DOHMH may also implement the model when products intended for ingestion and potentially used by at-risk populations in NYC are identified through alerts from federal agencies, state or other local jurisdictions, as well as published reports.

Determination of Product Availability in New York City

Once a hazardous consumer product has been identified, DOHMH visits NYC businesses to determine the availability of the actual products and similar products (e.g., products with the same manufacturer, same country of origin, or variants of a brand) for sale. DOHMH staff visit these stores incognito to inquire about suspected products and purchase products for testing, if necessary. Surveys of businesses may be conducted in commercial areas where likely users of suspect products may shop. For example, staff may visit NYC stores catering to South Asian communities to determine the availability of dietary supplements manufactured in India suspected to contain lead. Samples of collected products are sent to an accredited laboratory for analysis with the appropriate analytical methods.

Identifying hazardous products during a community survey has its challenges. Businesses may keep select products in private areas of a store and only retrieve them for certain customers. Identifying contaminated products is further made difficult because heavy metals are not always listed as an ingredient on product labels. Lead content may also vary considerably between different batches of the same product. Differentiating between safe and dangerous products can only be confirmed by laboratory testing.

Embargo and Enforcement

The NYC Health Code authorizes the Department to seize, embargo, or condemn any food, drug, or cosmetic that is unfit for human consumption or use, or “constitutes a danger or nuisance, or is otherwise prejudicial to public health.”¹² DOHMH can order businesses to cease sales and properly dispose of contaminated consumer products or to continue sale of products if business complies with DOHMH-specified labeling requirements. Food, dietary supplements, and other products intended for ingestion that are found to be contaminated with hazardous substances are prohibited from sale or distribution in NYC. Other products that are prohibited per federal law, such as kohl, are also similarly prohibited. Products that are not intended for ingestion can be sold provided they have warning messages on the labels. Warnings required on labels include precautionary messages such as “Do not swallow or put in mouth” or “Keep out of the reach of children and pets.” In addition, DOHMH has ordered acupuncturists and nutritionists who have prescribed contaminated supplements to stop prescribing these products and inform their patients about associated risks. DOHMH has issued orders on a variety of contaminated consumer products, including cosmetics, jewelry, dietary supplements, and other products found to be harmful to health.

DOHMH may serve an order in person or via mail to retail outlets identified through case interviews, store visits, Internet yellow pages, or specialty Web sites. Retailers are ordered to stop sale of banned consumer products and return remaining inventory to suppliers from which products were purchased. DOHMH inspectors may seize embargoed products when a supplier is not identified. Businesses may also be required to post a warning sign in a prominent location alerting patrons to the hazards of the embargoed products and to encourage users to contact their physician or the city’s Poison Control Center. The signs are printed in English and in the languages likely understood by users of the products. Follow-up inspections show a high level of compliance and cooperation among retail businesses in NYC ordered by DOHMH to cease sales of specific contaminated products.

Because the number of retail outlets that may sell a harmful product is unknown and may be quite large, DOHMH attempts to identify the wholesaler, distributor, or other supplier to stop the distribution at the source. DOHMH locates suppliers through product labeling or through information obtained from retail outlets known to sell the products. DOHMH has authority to order a supplier (i.e., wholesaler or distributor) to issue a product recall and to dispose of all returned products in accordance with applicable laws and regulations. Supplier information is forwarded to the appropriate state or federal agencies, such as the NYS Department of Agriculture and Markets, the NYS Department of Environmental Conservation (DEC), the US Food and Drug Administration (FDA), the Environmental Protection Agency, and the Consumer Product Safety Commission. In addition, the destruction or quarantine of certain embargoed products has been supervised by FDA or DEC. DOHMH refers suppliers located outside of NYC to the appropriate state or local agency.

Despite these efforts and those of federal, state, and other local agencies, contaminated consumer products continue to enter the US marketplace. Many of the products on which DOHMH has acted originated abroad, where product safety standards may not be as stringent. Ease of international travel increases access to these less regulated products. In addition, certain products available domestically are not covered by federal regulations, resulting in marketing of products with high lead content. For example, although children’s jewelry must meet lead limit standards established by the federal Consumer Product Safety Improvement Act, no such standards exist for adult jewelry.¹³ Added responsibilities are placed on already strained local health departments both to educate users about the risks of certain products obtained abroad and to act on harmful products available in local stores. The impact of local enforcement actions is limited and does not remove the hazard from other domestic and overseas markets.

Risk Communication and Public Education

Risk communication and educational activities are critical to curb the flow of contaminated consumer products and warn the public of identified hazards. Enforcement may not always be feasible because individuals may obtain such products directly from abroad or products may be available locally at unidentified outlets. Raising public and provider awareness bridges the gap when enforcement is not possible. DOHMH develops linguistically and culturally appropriate educational materials or activities, such as press releases, brochures, fact sheets, provider health alerts, and presentations. Key messages of risk communication activities include information on the type of hazard found in a prohibited product, a warning for consumers not to use the product, and encouraging users to speak to their providers.

An important step for public awareness activities is to ascertain the languages spoken by those likely to use the contaminated products. In addition to English, educational materials may be developed in a variety of languages. Languages are identified by examining literature and product labeling, languages spoken in the homes of lead poisoning cases associated with the products, and the demographic characteristics of customers who patronize businesses where the products are sold. The linguistic and cultural diversity of DOHMH employees, representing more than 20 languages, provides invaluable insight and knowledge in developing educational and outreach materials and successfully administering case interviews among diverse populations.

DOHMH educators disseminate educational materials at health fairs, community clinics, tenant meetings, and other community events. Educational materials are also distributed to the public through local community- and faith-based organizations. Local, national, international, and ethnic media outlets may provide further coverage. In addition, DOHMH releases health advisories on contaminated products to health care providers via its NYC Health Alert Network. The advisories inform providers on lead and other poisonings related to contaminated products, emphasize screening patients for use of potentially contaminated products, and remind providers to report poisonings as required by the NYC Health Code.

SUCCESSES

The Intervention Model for Contaminated Consumer Products is a multifaceted approach initially developed to address lead-contaminated products. The model of identification of hazardous consumer products, determination of product availability in NYC, embargo and enforcement, and risk communication and public education has also been used during investigations of consumer products containing other environmental hazards. Examples include imported cosmetics and supplements containing mercury or arsenic, and an illegally sold over-the-counter aphrodisiac associated with the death of a NYC man. A summary of major DOHMH investigations is presented in Table 1.

TABLE 1—

Contaminated Consumer Products Identified in New York City by New York City Department of Health and Mental Hygiene: 2000–2012.

Product Name	Manufacturer	Country of Origin	Usage Reported or Labeled	Hazard	Investigation Trigger
Cosmetics
Kohl, Kajal, or Surma	Various	India, Pakistan, Morocco, Saudi Arabia	Used to line the eyes; ward off evil eyes	Up to 930 000 ppm Pb	Case investigation referral from Baltimore Department of Health
Skin lightening cream	Various	Dominican Republic, European Economic Community, Jamaica	Lighten skin color	Up to 41 600 ppm Hg	NYC Health and Nutrition Examination Survey14
Supplements or traditional remedies
Abhrak Bhasma	Baidyanath	India	Promotes well-being and reduces excess Kapha	1200 ppm As	Community survey
				23 ppm Hg
				81 ppm Pb
Calabash Chalka	Unknown	Unknown	Morning sickness	10 ppm As	Texas Department of State Health Services and FDA alerts15
				6.6 ppm Pb
Emperor’s Tea Pill (concentrated)b	Lanzhou Traditional Herbs	China	Natural balance	3200 ppm Hg	Case investigation
				5400 ppm Pb
Garbha Chintamani Ras (Vrihat) (Swarna Yukt)	Baidyanath	India	Reproductive health	52 000 ppm As	Case investigation
				120 ppm Pb
Garbha Dharak Yog	Vyas Pharmaceuticals	India	Reproductive health	140 ppm As	Case investigation
				100 000 ppm Hg
				110 ppm Pb
Garbhapal Ras	Shri Vishwamitra Ayurved Pharmaceuticals	India	To have a male baby	81 ppm As	Case investigation
				4400 ppm Hg
				15 000 ppm Pb
Garbhapal Ras	Unknown	India	To keep pregnancy and fetus healthy	410 ppm As	Case investigation
				19 000 ppm Hg
				22 000 ppm Pb
Hepatico Extract (concentrated)c	Lanzhou Traditional Herbs	China	Promote a healthy liver and maintain regularity	5100 ppm Hg	Case investigation
				5900 ppm Pb
Jambrulin	Unjha Ayurvedic Pharmacy	India	Diabetes	35 ppm Hg	Literature report16/community survey
				24 300 ppm Pb
Kankayan Bati (Gulma)	Baidyanath	India	Skin problems	9.5 ppm As	Case investigation
				35 ppm Hg
				12 ppm Pb
Lakshmivilash Ras (Nardiya)	Baidyanath	India	Chronic fever, cold, and cough	42 ppm As	Literature report17/community survey
				14 100 ppm Hg
				260 ppm Pb
Laxmi Vilas Ras (Nardiya)	Dabur	India	Improve immune function	59 000 ppm Hg	Case investigation
Laxmana Louh	Vyas Pharmaceuticals	India	Reproductive health	12 ppm As	Case investigation
				120 ppm Hg
				180 ppm Pb
Litargirio	Unknown	Dominican Republic	Skin problems and deodorant	790 000 ppm Pb	Literature report2
Maha Sudarshan	Arya Aushadhi Pharmaceutical Works	India	Flu and body ache	11 ppm As	Literature report17/community survey
				2190 ppm Hg
				41 ppm Pb
Mahashakti Rasayan	Vyas Pharmaceuticals	India	Weakness	1700 ppm As	Case investigation
				70 000 ppm Hg
				9400 ppm Pb
Mahayogaraj Guggulu (enriched with silver)	Baidyanath	India	Rheumatic pain	4300 ppm As	Case investigation
				4800 ppm Hg
				47 000 ppm Pb
Ovarin	Ban Labs Ltd.	India	Facilitate ovulation and reproductive health	1000 ppm As	Case investigation
				70 000 ppm Hg
				24 000 ppm Pb
Pigmento	Charak Pharma Pvt. Ltd.	India	Improve skin complexion	27 ppm As	Case investigation
				29 000 ppm Hg
				7.3 ppm Pb
Praval Pishti	Unknown	India	Improve brain development	17 000 ppm Pb	Case investigation
Pregnita	Ajmera Pharmaceuticals	India	Pregnancy-related nausea and vomiting	12 000 ppm Pb	Case investigation
Sorin	Research Drugs & Pharmaceuticals	India	Eczema	46 707 ppm Pb	Case investigation
Swarna Malini Vasant	Amrita Drugs	India	Improve immune function	1300 ppm As	Case investigation
				32 000 ppm Hg
				31 000 ppm Pb
Tierra Santad	Unknown	Mexico	Cleanse stomach for pregnancy	13 ppm Pb	Case investigation
				11 ppm As
Vasant Kusumakar Ras (with gold and pearl)	Dabur	India	Diabetes and weakness	31 000 ppm Hg	Case investigation
				29 ppm Pb
Vatvidhwansan Ras	Baidyanath	India	Skin problems	130 ppm As	Case investigation
				15 000 ppm Hg
				20 000 ppm Pb
Vita Breath	American Herbal Laboratories	United States	Incontinence and to test the “strength of meridians”	1100 ppm Pb	Case investigation
Over-the-counter medications
Cordial de Monell	Castillo (distributor)	Dominican Republic	Teething and colic in infants and young children	Potassium bromide	Poison Control Center report18
Piedrae	Unknown	Unknown	Topical aphrodisiac to extend male erection	Bufotenine and related Bufadienolides	Case investigation19
Toys, jewelry and novelties
Variety of toys, jewelry, and novelties	Various	Various	Toy/jewelry/novelty items	Up to 870 000 ppm Pb	Case investigation, community surveys, CPSC recalls, and other reports
Other: Camphor	Various	Various	Camphor cubes used as a pesticide, for respiratory illness, religious purposes, ward off evil	Camphor	Poison Control Center report20

Note. As = arsenic; CPSC = Consumer Product Safety Commission; FDA = Food and Drug Administration; Hg = mercury; Pb = lead; ppm = parts per million.

^aAlso known as Argile, Calabar Stone, Calabash Clay, La Craie, Mabele, Ndom, Nzu, or Poto.

^bLot No. 010705, expiration date July 2010.

^cLot No. 040804, expiration date August 2009; Lot No. 100105, expiration date January 2010; Lot No. 110604, expiration date June 2009.

^dAlso known as Panito del Señor.

^eAlso known as Rock Hard, Hard Rock, Black Stone, Stone, or Love Stone.

Implementing the model is resource intensive. Personnel are required to identify and remove products, as well as to inform the public. Fiscal resources are required to test products and to dispose of products when necessary. The success of the model relies on the coordination of internal resources and collaborations with governmental, media, community-based, and faith-based organizations. Collaboration among a variety of stakeholders minimizes duplication of efforts and extends DOHMH’s capacity to disseminate public health messages to at-risk, difficult to reach communities. Despite some challenges, the model has resulted in the removal of thousands of contaminated consumer products from local retail and wholesale outlets, and continues to raise awareness of hazardous consumer products.