Government Regulations in the OTC Drug and Dietary Supplement World - Does the Profusion Lead to Confusion?

Regulations, regulations, regulations…no matter what industry in which you are working, it is likely to be governed by some type of federal regulation.  Regardless of whether you believe them to be useful and necessary or just burdensome, compliance is expected and this is often difficult due to the very breadth and nature of what is required.  Ignorance of any of these regulations will not serve as an adequate excuse in the event of an inspection by a federal authority.

In the pharmaceutical/dietary supplement industry, regulatory professionals concentrate on those regulations promulgated by the Food and Drug Administration which cover nearly everything – good manufacturing practice, labeling, drug applications, recalls and much more. While certainly comprehensive, there are other government agencies whose rules and regulations are applicable to over-the-counter (OTC) drug and dietary supplement products.  These include:

Consumer Product Safety Commission – The CPSC is tasked with protecting the public from unreasonable risk of injury or death. As such, it administers the Poison Prevention Packaging Act that requires child-resistant packaging for hazardous household products. This includes most oral prescription drugs as well as specified OTCs and dietary supplements.  The agency also oversees the Consumer Product Safety Improvement Act that requires the issuance of a Certificate of Conformance for any product that is subject to a CPSC rule.

Drug Enforcement Administration – The DEA is responsible for enforcing the controlled substances laws and regulations.  While most controlled substances are prescription drugs, there are a few OTC products within the DEA’s scope as well.  All of these have additional labeling, packaging, record-keeping and other requirements.

Federal Trade Commission – The FTC protects the public from unfair, deceptive or fraudulent practices in the marketplace. As such it collaborates with the FDA in identifying those drug or dietary supplement products making unsubstantiated claims or that have false or misleading advertisements.

United States Pharmacopeial Convention – The USP is a scientific organization that sets standards for the identity, strength, quality and purity of medicines, food ingredients and dietary supplements. Although not a federal agency, its standards are legally enforceable by the FDA.

In addition to the above, there are other laws that have been enacted by Congress in recent years that impact the manufacture and distribution of OTC drugs and dietary supplements, of which regulatory professionals must be cognizant.

Dietary Supplement and Non-prescription Drug Consumer Protection Act – This law was enacted in 2006 and requires manufacturers, packers or distributors whose name appears on an OTC drug or dietary supplement label to submit to the FDA any report received of a serious adverse event associated with their products.  To accomplish this, product labels must include contact details (telephone number or full domestic address) through which the adverse event details can be reported.

Food Allergen Labeling and Consumer Protection Act – This law applies to dietary supplements as well as food and was enacted in 2004 (the labeling provisions of which became effective in 2006).  It identifies eight major food allergens which, if present in the product, must be declared on the label.

Keeping up with existing government regulations, as well as new initiatives that come along, is not an easy task. While larger companies have the luxury of employing departments staffed with experienced and knowledgeable professionals, smaller firms may have only one or two people who are expected to keep the company in compliance (and may have other responsibilities as well.)  Fortunately, there are numerous consulting firms that can provide this expertise and at a cost far lower than that of a product recall should a company’s compliance efforts fall short.  Reaching and maintaining a state of compliance is not only good for your company, it is good for your customers too as they can be assured of purchasing a quality product.