As of recent, the Food and Drug Administration (FDA) has been enforcing the drug regulations on a relatively benign class of over the counter (OTC) pharmaceuticals, mouthwashes and other related personal care products. What the agency is enforcing can be a very gray area for these manufacturers and other firms that "own" and distribute their own brands (i.e. retail pharmacies that have their own private label products).

This article provides personal care product manufacturers and private label distributors with Advanced Biomedical Consulting's (ABC) recommendations for avoiding FDA actions associated with ingredient issues and associated noncompliant label claims.

What Makes a Personal Care Product a Drug?

Believe it or not, just about any consumable or topical product can become a drug in accordance with the laws and regulations. Even a bar of soap can be considered a drug! The following are the two areas in which FDA determines whether a product is considered a drug or not.

1. What's In It?

If a product has a specific ingredient, it may be a classified as a drug product and hence must be preapproved by FDA prior to marketing regardless of its intended use. For example, a breath spray containing mint alone as a breath freshening agent would not itself be considered or regulated as a drug product. However, if that same spray contained chlorhexidine, an active ingredient used in fighting plaque, that product would need to be registered as a drug. Therefore, the ingredients in a product are a factor in whether a product is considered a drug product or not by FDA.

2. What Are the Claims?



The second and grayer area associated with determining a product's classification is the label claims. First, it is important to understand that FDA considers "labeling" to really mean any written OR verbal claims associated with the product. For example, FDA can and does assess what is written on the label, what is on a website, or even what a sales representative is claiming about a product's intended uses when enforcing Section 201(g) of the Federal Food, Drug, and Cosmetic Act (Act). The law and regulations state that any product's labeling that purports that the product is intended for use in the prevention or mitigation of disease, or is intended to affect the structure or function of the human body, is consistent with a drug product. While there are several reasons why certain companies get cited and why others do not despite apparently similar claims, product marketers and regulatory affairs professionals often have to "ride the line" when interpreting this requirement in order to stay competitive, yet under the radar of the FDA. For example, if that same breath spray marketer specifies that its breath spray with only natural mint as an "active ingredient" helps prevent gingivitis and helps to fight plaque, then this product would be considered a drug product for those claims despite the fact that it does not contain any registered drug active ingredient.

Current Mouthwash Issues

Some of the largest and smallest firms are being targeted by FDA for not complying with a combination of an aspect of the label claim issue discussed above and by crossing too far over the marketing claims line. While there are numerous compliance issues being cited, the most common has to do with the fact that the acceptable active ingredients (i.e. approved drug substances) are not consistent with the approved claims that a company can make for that substance. For example, one well-known brand has been recently cited for its claims associated with Sodium Fluoride. Sodium Fluoride is approved for cavity prevention label claims. However, the firm also states that the mouthwash product it markets fights plaque and gingivitis. Plaque and gingivitis are not associated with cavities, but instead are associated with gum disease. Sodium Fluoride is not approved for the prevention or mitigation of gum disease. Therefore, the product is considered an unapproved drug, and the company was cited as such.

Sustainable Compliance

So, how do small and large firms alike avoid regulatory action with seemingly minor inconsistencies in labeling? One method is to utilize an existing regulatory requirement for documenting change control. Change control is a regulatory requirement for drug manufacturers that involves documented reviews of manufacturing and other changes prior to, during, and after implementation to ensure effectiveness and includes a team of individuals responsible for "OKing" the change prior to implementation. Label changes are often just submitted to the Quality or Regulatory Departments for approval. Website revisions are typically executed without any quality or regulatory oversight. Therefore, it is recommended that any "labeling" changes be subject to the complete change control process prior to implementation.

As labeling (including but not limited to product labels, patient inserts, and websites) often changes many times during a product's lifecycle, many companies find it cost-effective to hire consultants with many years of experience in FDA regulated industry services execute these label reviews. Not only do many of these consulting firms like Advanced Biomedical Consulting (ABC), LLC have over 80 years of this experience in-house, but using such an organization can save a company significant time and money in getting labeling (and hence product) to market faster.

For more information about how to cost-effectively address potential or current state or FDA issues, feel free to contact ABC here for a no obligation quote. If you contact ABC before 29OCT10 and mention this article, ABC will offer 15% OFF our standard rates for labeling compliance reviews.

 (Saint Petersburg, FL - October 01, 2010)