Make sure the chiropractic products you sell in your office are FDA compliant

Are you using or selling products in your office that specify a health claim? If you are like nearly half of all chiropractors, then you are selling products in your office. In 2002, the US government estimated that chiropractors sold $320 million in health care products, including $179 million worth of nutritional supplements, vitamins, and herbal remedies.1

Leading Food and Drug Administration (FDA) regulatory experts have recently recognized that a significant percentage of these products sold by health care professionals, including chiropractors, are not FDA compliant. Though it is the manufacturer and distributor’s responsibility for FDA compliance, as a physician, if you are participating in promotion of false health claims, you and your practice may be at legal risk. Here is the background information you need to know before you make your next sale.

The FDA’s mission is to protect the public’s health by assuring the safety, efficacy and security of drugs, medical devices, food, and cosmetics. Though chiropractors are obviously not affected by the drug oversight, most chiropractors use or sell medical devices, food supplements, and cosmetic products that need to be listed with or approved by the FDA before being sold on the market. Section 510 of the Federal Food, Drug, and Cosmetic Act (FDCA), requires companies located on US soil that are engaged in manufacturing, preparing, propagating, compounding, assembling, processing, sterilizing, packaging, distributing, importing, or exporting must register themselves annually with the FDA.

Similarly, any device, nutritional supplement, or cosmetic that purports a specific health benefit must be listed or approved for safety and efficacy. Certain products also require clinical testing and special manufacturing procedures for quality assurance. Manufacturers have to be prepared to back up good manufacturing principles and health claims with some scientific proof for FDA clearance or they may face an FDA audit, possible closure of their operations, or even the threat of prosecution.

In evaluating a qualified health claim by a manufacturer, the FDA reviews the submitted scientific studies for persuasiveness, pertinence, significance, and overall study design to determine the relationship of the product and the health claim. The FDA will also account for other related information, including meta-analyses, review articles, and animal and in vitro studies. Application errors can cost millions of dollars in additional clinical testing and lead to years of delaying the product launch. Product labeling errors can generate cease-and-desist letters from the FDA. Worst of all, manufacturing deficiencies can result in a complete shutdown of business operations.

A company registered with the FDA simply tells the FDA about the company, and listing devices essentially registers and classifies specific products with the FDA. Take note that a registered company and listed device is not an endorsement or approval by the FDA.

The FDA is careful not to endorse or recommend use of specific products, but to provide the scientific information for consumers and health care professionals to make informed decisions.

Nutritional supplements. For food products or nutritional supplements, a health claim “characterizes the relationship between a substance (the food or a component of the food) and a disease or health-related condition” (21 CFR 101.14(a)). According to the FDCA, the substance must be present at a level necessary to justify a claim and also at levels considered safe for consumption. Though conventional foods are subject to GRAS (generally recognized as safe) levels, dietary supplements, including vitamins, minerals, herbs, botanicals, concentrates, metabolites, constituents, extracts, and combinations that were not marketed before October 15, 1994, are subjected to additional levels of safety. Such products, if not correctly labeled and marketed, could be subject to recalls and legal actions. Knowingly promoting such nutritional products that are incorrectly labeled means that you are either misleading your patients or putting them at a safety risk.

Medical devices. According to the FDCA, medical devices are any apparatus “intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease or intended to affect the structure of any function of the body of man … and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes.” Examples of medical devices in the typical chiropractic office range from tongue depressors to support braces to therapeutic equipment.

There can be a fuzzy distinction between a consumer product and a medical device, but the intended use of the product determines its classification. For example, if a company sold a drill in hardware store, the drill is clearly a consumer product, but if that same drill were sold to surgeons to drill holes in a skull, then that same drill now becomes a medical device because it is intended for medical use.

If a device requires FDA clearance or approval, then there are several options. A premarket approval (PMA) is required for unique devices for which there is no substantially equivalent or similar product currently on the market. For devices that have substantially equivalent products already on the market or for those products with electronic components, a premarket notification submission (commonly referred to as a 510(k)) is required.

Class I devices, those that can be shown to be safe and effective using general controls, and certain Class II medical devices are exempt from 510(k) submissions, but the manufacturer is still required to register and list the device. Additionally, depending on the classification of the device, certain quality manufacturing protocols also need to be in place.

Cosmetic products. The FDA also regulates the labeling, ingredients declaration, and packaging of cosmetic products. According to the FDCA, cosmetics are substances applied to the body for “cleansing, beautifying, promoting attractiveness, or altering the appearance without affecting the body’s structure or functions,” including creams, lotions, and sprays. Requirements for cosmetic products are less stringent than other FDA-regulated products and do not require approval before being sold on the market, unless those cosmetics include drugs as part of their constitution.

Product Review
Before handing over that next orthotic, vitamin bottle, pillow, or sports gel, you should carefully read the label, packaging and enclosed brochures to determine what, if any, health claims are being made by the manufacturer or distributor. If any specific health claims are being made, you should contact the company to confirm that they have complied with FDA regulations or check their approval online at www.fda.gov. Even if you have been working with a company for 10 to 20 years, it behooves you to confirm their health claims and FDA compliance, because it is your professional reputation on the line.

Your patients trust you with their health and the health of their family members. They count on you for proper recommendations of safe and effective health care products for better health, improved posture, and decreased pain. Although FDA-approved products are occasionally subjected to recalls, be sure that your products are FDA compliant. Not only is it safer for you and your patients, it is also the law.

For more information, visit these Web sites: Food & Drug Administration: www.fda.gov; mdi Consultants: www.mdiconsultants.com; BrainStorm Group: www.brainstormgrp.com. CP

Mark Mandell, DC, MBA, is the founder of BrainStorm Group, a marketing and regulatory strategy consulting firm for chiropractic and health care product companies, which has advised Fortune 1000 companies and start-ups worldwide. He is a third-generation chiropractor, developed a prototype chiropractic clinic for a Veterans Affairs facility, and a CP editorial advisory board member. Mandell can be reached at: brainstormgroup@hotmail.com or (732) 257-2463.

Reference
1. US Census Bureau, US Dept of Commerce. 2002 US Economic Census, Ambulatory Health Care Services: 2002. Table 3: Product Lines by Kind of Business for the United States. Washington, DC: US Census Bureau, US Dept of Commerce; October 2004.