Understanding the Drug-Cosmetic Conundrum When Marketing Your Products

Products marketed as cosmetics can easily find themselves the target of FDA compliance action based on improper claims and statements.

FDA is charged with enforcing the laws and regulations that ensure the safety and labeling of products, including cosmetics, that account for 20 – 25 % of all U.S. consumer spending.

Cosmetics were first regulated under the 1938 Federal Food, Drug and Cosmetic Act (FFDCA). They are defined as “(1) 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, and (2) articles intended for use as a component of any such articles…”.

By comparison, drugs are defined as articles (1) intended to treat or prevent disease or (2) that affect the structure or function of the body. Cosmetics are products that provide mostly superficial effects that do not include “nutrition” as with foods or that “treat or prevent disease or affect the structure or function of the body” as with drugs. Because of the narrow definition and generally low safety risk for cosmetics, they can be marketed, with the exception of color additives, without pre-approval by FDA.

As with all products regulated by FDA, cosmetics must be safe and properly labeled. A cosmetic is considered unsafe (adulterated) if (among other things) “it bears or contains any poisonous or deleterious substance which may render it injurious to users under the conditions of use prescribed in the labeling thereof, or under such conditions of use as are customary or usual…”. Also, cosmetics must be labeled in accordance with the applicable laws which include the FFDCA and the Fair Packaging and Labeling Act (FPLA).

Under this regulatory framework, a product can be classified as both a drug and a cosmetic. Product classification depends on the intended use which is determined based on claims made for marketing the product and whether or not the statements fit the definition for cosmetics and/or drugs. Because of the difference in the regulatory schemes for cosmetics and drugs, FDA has sought over the years to make sure that a marketed product stays within the established boundaries that apply. For example, a cosmetic may not make claims that the product will treat and prevent a disease or alter the structure or function of the body.

So how does one tell what claims pose a risk that a product will be classified as a drug and subject to FDA compliance action? This is a complicated question and there are no quick, easy answers. Product classification does not necessarily depend on the presence of a single word or phrase and FDA will typically make a determination based on all product statements and representations or “claims” taken together. FDA’s Warning Letters provide the most readily available source of information on claims.

Let’s look at what types of claims are problematic based on recent warning letters. Many problem claims relate to a structure or function of the body (skin) which is appropriate for a drug rather than a cosmetic.

A warning letter dated October 18, 2016, based on an establishment inspection and a website review, noted:

  • The product label said, “It stimulates cell-cell interaction, assists in the formation of collagen, and increases skin elasticity…”
  • The website included the claims “Stimulates cell-cell interactions, and accelerates cell renewal” and “Helps to preserve cellular energy, assists the formulation of collagen and strengthens in structural proteins”
  • The product insert included the claims “[I]nduces signal transduction…reconstructs protein structure…acts as a topical Botox…”, “[S]timulates cell respiration and increases cell turnover.”, “[A] biosafe alternative to Botox, it relaxes muscle contraction…” and “Increase Microcirculation”.

A warning letter dated September 20, 2016, based on a website review, cited the following claims:

  • “Lemon, a powerhouse of vitamin C…with its antibacterial properties, and boosts collagen production…It also lightens age spots…”
  • “By increasing blood flow…”
  • “Organic shea butter is a powerhouse… has natural anti-inflammatory properties that can take the sting out of insect bites.”

A warning letter dated April 14, 2016, based on a website review, noted:

  • The product website included the claim – “Removes Wrinkles Instantly”
  • Product Ingredient Claims – “Tests using a 0.5% concentration of the culture have shown a clear reduction of uneven pigmentation and obvious lightening if the skin.”
  • “A super anti-oxidant …eliminates age spots, contains protection from ultraviolet A and B and boosts collagen synthesis.”

As you can see from these examples, products marketed as cosmetics can attract FDA compliance action based on improper claims and statements. The FDA issued more than 29 warning letters to cosmetic firms in 2016.

EAS labeling experts are available to assist with the regulatory compliance of claims for cosmetic products.

Using Temporary Marketing Permits for Food Products

FDA food standards of identity are regulations that establish the names and define the basic nature of certain foods. Food standards prescribe, among other things, what ingredients are required or optional and may describe the manufacturing process when that process has a bearing on the identity of the food. If a food is labeled with the name that is included in a food standard of identity, it must comply with that food standard. If it does not meet the standard, it is a non-compliant food product.

So, how can you market foods that have food standards of identity if you want to use a new ingredient or new technology not included in the food standard? You have to either ask FDA to revise the food standard regulation or you must use a different name. However, if you want to use the name specified in the food standard regulation, you can still market a product that deviates from the food standard if you obtain a temporary marketing permit (TMP). A TMP is permission to market a food under a standardized name that deviates from that food standard of identity.

FDA recognized that prior to revising a food standard, market testing is needed to assess the feasibility of making the change and to test for consumer acceptance of the food. Therefore, it established procedures for TMPs that allow manufacturers to market test their products before a standard of identity is revised.

Manufacturers may request a TMP under regulations in 21 CFR 130.17. This regulation requires manufacturers to submit certain information with their application, including information about the applicant, a description of the deviation from the food standard, a statement on how the deviation is advantageous, and proposed labels for the food.

FDA will evaluate the information provided in the TMP application to see if any new ingredient is safe and determine whether the manufacturer has given a rational basis for the deviation from the standard. If FDA grants the TMP, it publishes a notice in the Federal Register granting the TMP for 15 months. The TMP will expire in 15 months from the date the product first enters interstate commerce, but can be extended by application to FDA. When applying for an extended TMP, the applicant must simultaneously submit a petition to revise the food standard regulation. If FDA grants the extension, it publishes a notice in the Federal Register and invites other interested parties to market the product. This extended TMP is in effect until FDA makes a ruling on the petition to amend the food standard.

It is important to note that FDA thoroughly reviews the TMP to determine if there is a rational basis for the deviation and that consumers are not misled by the name or label. FDA also reviews the labels for compliance and needs to accept the labels prior to granting the TMP. Receiving a TMP is an important step in revising food standards to address innovation. EAS consultants are available to assist manufacturers in applying for a TMP.

FDA’s Revised Draft Guidance on Listeria Controls

FDA released updated draft guidance on preventive controls for Listeria monocytogenes in ready-to-eat foods last month, adopting the “seek and destroy” approach used by USDA’s Food Safety and Inspection Service.

Facilities that produce ready-to-eat foods that are regulated by both FDA and USDA will benefit from a uniform federal approach, the agency says.

As every food facility manager knows, the persistence of Lm in processing facilities – in hard-to-reach locations such as drains and ducts – presents a serious challenge for food safety personnel. The hardy pathogen can find its way onto food contact surfaces and can then contaminate the food products. To make matters worse, it survives refrigeration temperatures, so the only effective preventive measure is to keep Lm away from ready-to-eat foods.

The updated guidance includes recommended procedures for environmental sampling and schedules for routine cleaning and sanitizing. Generally, the agency recommends that food contact surfaces should be cleaned and sanitized at least once every 24 hours. But the schedule for any surface needs to be based on the characteristics of the products and processes, the agency says.

If you clean and sanitize less frequently than every 24 hours, you should validate the frequency of your cleaning and sanitizing by microbial testing and not allow the reduced frequency to impact the microbiological condition of the production equipment, it says. And if the results of environmental monitoring or product testing indicate a problem, you should consider increasing the frequency of cleaning and sanitizing as part of an overall corrective action procedure.

The updated guidance suggests that non-food-contact surfaces such as drains, floors, waste containers, cleaning tools — and any surfaces that have a greater potential to become a source of Lm contamination – should be cleaned and sanitized every day. This would include surfaces likely to be touched by personnel who touch the food products or food contact surfaces, or areas where there could be a build-up of moisture or product residues.

Other non-food-contact surfaces such as condensate drip pans, overhead piping, ceilings and walls, coolers, and HVAC systems should be cleaned and sanitized weekly or monthly, the agency says. Motor housings and external surfaces of enclosed processing systems should be cleaned and sanitized weekly. Freezers containing exposed ready-to-eat foods and the interiors of ice makers should be cleaned and sanitized semi-annually, the guidance recommends.

I believe that effective implementation of this Lm draft guidance in RTE facilities would go a long way to address one of the toughest food safety challenges. And the careful documentation of all these activities would show FDA inspectors the facilities are implementing all the necessary preventive measures.