Exporting to the US: important guidance

Being the oldest consumer protection agency in the US federal government, the FDA is responsible for ensuring the safety and efficacy of the products it regulates. Their reach is expansive. Goods falling under the oversight of the FDA account for about 25% of every consumer dollar spent. The Food, Drug, and Cosmetics Act of 1938 (FD&C Act) clearly defines intended uses for products. To best determine the intended use, the FDA employs several methods including product claims (both on packaging, printed materials, web sites, etc.), consumer perception or product reputation, and active ingredients for drug products. For example, according to the FD&C Act, cosmetics are “articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance” [FD&C Act, sec. 201(i)]. For those products with a drug component, the intended use will differ. Drugs are “articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; and articles (other than food) intended to affect the structure or any function of the body of man or other animals” [FD&C Act, sec. 201(g)]. Drugs achieve this through chemical action. In the case of personal care products, some meet the definition of both cosmetics and drugs. This may happen when a product has two intended uses. For example, a shampoo is a cosmetic because its intended use is to cleanse the hair. An antidandruff treatment is a drug because its intended use is to treat dandruff. Consequently, an antidandruff shampoo is both a cosmetic and a drug. Among other cosmetic/drug combinations are toothpastes that contain fluoride, deodorants that are also antiperspirants, and moisturisers and makeup marketed with sun-protection claims. Such products must comply with the requirements for both cosmetics and drugs.

Categorising

The drug category most often associated with personal care products is Over-the-Counter (OTC). These drugs are intended to cure, mitigate or treat a disease or disease related condition but can be used safely without medical supervision. The consumer availability is “over the counter”, i.e., without a prescription. An OTC designation is based on active ingredients and purpose. To directly regulate drug products, the FDA uses either a New Drug Application (NDA) or an Over-the-Counter (OTC) Drug Monograph. An NDA is drug productspecific. The drug product is not generally recognised as safe and effective (not GRASE) and requires pre-market approval. By contrast, OTC Drug Monographs are active ingredient-specific. This drug product is GRASE and does not require pre-market approval. Among other requirements, the monographs describe required or acceptable ingredients, testing, and labelling of the product. Examples of drug products currently covered by OTC monographs include acne medications, treatments for dandruff, topical analgesics, and sunscreens. More information on monographs can be found by viewing the FDA Status of OTC Rulemakings for specific products and topics. Although not a complete OTC list, the status page provides appropriate guidance. The OTC monograph for sunscreens is a specific example from this status page. Sunscreens are regulated as drugs in the U.S. because of a 1999 final rule that “…affect the structure and function of the body by absorbing, reflecting or scattering harmful, burning rays of the sun.” A proposed rule issued in August 2007, sets standards for formulating, testing, and labelling OTC sunscreens with UVA and UVB protection based on a rating system for UVA on a scale of 1 to 4 stars. The proposed rule also sets a range for UVB SPF2 to SPF50+, revises existing SPF UVB testing procedures, and allows new combinations of active ingredients. FDA has not yet issued a final rule. Registration requirements for cosmetics and OTC drugs differ. The FDA launched the Voluntary Cosmetic Registration Program (VCRP) for cosmetic establishments and formulations in December 2005. Requirements for OTC drugs include establishment registration, drug listing, and US Agent designations for foreign establishments. It is important to note that registration and listings are necessary for articles considered drug products. Drug products that are not properly listed as required are considered misbranded and may be subject to regulatory action. Establishment owners and operators (registrants) are required to submit registration information for their establishments on or before December 31 of each year. They are also required to submit listing information at the time of registration and to update listing information in June and December of each year to include information for drugs that have not been previously listed. If no changes have occurred since the previously submitted listing, no report is required. Domestic establishments that manufacture, repack, or re-label drug products must register. Foreign establishments that manufacture, repack, or re-label drug products and offer for import drug products to the United States must also register and identify a United States Agent. The US Agent assists the FDA in communications with the foreign drug establishment, responds to questions concerning products that are imported or offered for import, and assists in scheduling inspections. The US Agent must reside in the United States. The registration, listing, and label information must be submitted in the English language. A vital relationship to consider when listing is the partnership between the Private Label Distributor (PLD) and the manufacturer. The PLD is the company whose label appears on the product. The manufacturer is required to list. On the other hand, the PLD is not required to register or list but can list on behalf of the manufacturer. In either case, the PLD’s National Drug Code (NDC) number is used. According to FDA’s guidance, only one listing per product is required.