FDA Warns Cosmetic Companies to Tone Down Anti-Aging Claims

After years of looking the other way, the FDA is going after cosmetic companies for how they market their products.  In the past two months, the agency sent warning letters to at least six companies, including Avon and Lancôme, for making drug-like anti-aging claims about their products.  As a comparison, according to the FDA's public database, the agency only issued between one to three warning letters per year between 2004 and 2011 (none between 2006 and 2010) regarding similar claims.

Claims made for these products to which the FDA objected include:

• The at-home answer to wrinkle-filling injections. Start rebuilding collagen in just 48 hours.
• Rebuild collagen to help plump out lines and wrinkles.
• Stimulate elastin to help improve elasticity and resilience.
• Regenerate hydroproteins to help visibly minimize creasing.
• helps reactivate skin’s repair process to recreate fresh skin & help dramatically reverse visible wrinkles.
• help boost production of collagen and elastin.
• See significant deep wrinkle reduction in UV damaged skin, clinically proven.
• Immediate lifting, lasting repositioning. Inspired by eye-lifting surgical techniques . . . helps recreate a younger, lifted look in the delicate eye area.

Under the federal Food Drug & Cosmetic Act, a product intended to diagnose, mitigate, treat, or prevent disease, or to affect the structure or function of the body is classified as a drug.  If such a product is not generally recognized by qualified experts as safe and effective when used as labeled, it is a “new drug” and requires an approved New Drug Application to be marketed legally in the U.S.

The FDA gave these companies 15 days to respond to the warning letters.  If you have any questions about the warning letters or any claims about your cosmetic products, please contact the firm.

Avon Warning Letter: http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2012/ucm323738.htm

Lancôme Warning Letter: http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2012/ucm318809.htm

FDA issues guidance for off-label communication

The FDA issued draft guidance this week clarifying conditions under which drug and medical device makers may provide information on off-label uses.  The draft guidance covers unsolicited requests for off-label information.  An unsolicited request is one not initiated in any form by the drug or device maker (or its affiliates) itself.

For a company's response to nonpublic (one-on-one communication) unsolicited requests, the agency has made the following 7 recommendations:

• Response information should be limited to the requestor and treated as private, one-on-one communication.
• Information should be limited to the scope of the initial question.
• Information should be "truthful, non-misleading, accurate, and balanced."
• Information should be scientific in nature.
• Information should be generated "by medical or scientific personnel independent from sales or marketing departments."
• Information should be accompanied by several documents, including a statement notifying the recipient that FDA has not approved the product for the specific off-label use.
• The responding firm should maintain required records, including any follow-up questions from the requester.

For a company responding in public to public (Web sites, discussion boards, and chat rooms that are created and maintained by people other than the manufacturer or its affiliates) unsolicited requests, FDA makes the following 4 recommendations:

• A firm should respond only to a request about its own named product and is not solely about a competitor's product.
• The firm's response "should be limited to providing [its] contact information and should not include any off-label information."
• Those responding on behalf of the firm should clearly disclose their specific involvement with that firm.
• Responses "should not be promotional in nature or tone."

Public comments and suggestions regarding the draft guidance should be submitted within 90 days its publication.

FDA to exempt certain devices from 510(k) process

The FDA released a guidance that will relax the agency's requirements for 510(k) clearance for some medical devices.

The FDA has identified certain class I and class II in vitro diagnostic and radiology devices that have established safety and effectiveness profiles and for which it intends to exempt from the 510(k) process.

While the FDA proposes and finalizes regulations for the down classification and exemption changes, the agency said it intends to exercise enforcement discretion with regard to 510(k) submission requirements for these devices.

FDA proposes regulation of mobile apps

The FDA announced its proposed regulatory approach for mobile medical applications, or apps, designed for smart phones and other handheld devices.

In a draft proposal, the agency defines a small subset of mobile medical apps that affect or may affect the performance or functionality of currently regulated medical devices.  This subset includes mobile medical apps that:

• Are used as an accessory to medical devices already regulated by the FDA (for example, an application that allows a health care professional to make a specific diagnosis by viewing a medical image from a picture archiving and communication system (PACS) on a smartphone or a mobile tablet); or
• Transform a mobile communications device into a regulated medical device by using attachments, sensors or other devices (for example, an application that turns a smartphone into an electrocardiogram machine to detect abnormal heart rhythms or determine whether a patient is experiencing a myocardial infarction). 

 The draft guidance excludes the following from regulation:

• Mobile apps that are electronic "copies" of medical textbooks, teaching aids or reference materials, or are solely used to provide clinicians with training or reinforce training previously received.
• Mobile apps that are solely used to log, record, track, evaluate, or make decisions or suggestions related to developing or maintaining general health and wellness. Such decisions, suggestions, or recommendations are not intended for curing, treating, seeking treatment for mitigating, or diagnosing a specific disease, disorder, patient state, or any specific, identifiable health condition.
• Mobile apps that only automate general office operations with functionalities that include billing, inventory, appointments, or insurance transactions.
• Mobile apps that are generic aids that assist users but are not commercially marketed for a specific medical indication.
• Mobile apps that perform the functionality of an electronic health record system or personal health record system.

The agency is seeking input from the public on its draft guidance.  Comments can be submitted for 90 days online or by writing to: Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852. The FDA will update the guidance based on feedback received.

FDA to Exempt Certain Diagnostic (IVD) and Radiology Devices from 510(k) Requirements

The FDA has issued a draft guidance that would exempt 30 different device typess from 510(k) clearance requirements. These devices include common urine and blood tests, alcohol breath tests, blood clotting protein tests and radiology device accessories.

According to the draft guidance, the in vitro diagnostic (IVD) and radiology devices have well-established safety and effectiveness profiles, so the FDA plans to use its enforcement discretion to exempt the device from premarket notification requirements as long as those devices “do not exceed the limitations on exemption specified in the device classification regulations.” In the future, the FDA also intends to reduce the pre-market regulatory burden on additional IVDs and radiology device types.

The FDA said it intends to continue to enforce all other applicable requirements for the devices, including, but not limited to, registration and listing and current good manufacturing practice regulations as set forth in the quality system regulations.

FDA Issues Draft Guidance On New Dietary Ingredients

The FDA announced today that it has issued draft guidance clarifying agency expectations on new dietary ingredients (NDI) for industry.  The guidance addresses in question-and-answer format what qualifies as an NDI ("a dietary ingredient that was not marketed in the United States before October 15, 1994"), when an NDI notification is necessary, the procedures for submitting an NDI notification, the types of data and information that the FDA recommends manufacturers and distributors consider when they evaluate the safety of a dietary supplement containing an NDI, and what should be included in an NDI notification.

Dietary supplement manufacturers are required to notify the FDA in advance when they intend to add a NDI to their products.  However, in certain situations when the ingredient has been part of the food supply (and is still considered an NDI), an NDI notification to the FDA is not required if it has not been chemically altered for use in supplements.

Under the guidance, minor loss of volatile components, dehydration, lyophilization, milling, and formation of a tincture or a solution in water, a slurry, a powder, or a solid in suspension do not chemically alter an ingredient.

However, the following are examples of processes that the FDA would consider to involve chemical alteration:

• A process which makes or breaks chemical bonds such as hydrolysis or esterification, unless the bonds created by the process are reversed when the ingredient is dissolved in water (e.g., creation of a soluble salt) or during ingestion.
• Removal of some components of a tincture or solution in water (e.g., by chromatography, distillation or membrane filtration), which changes the chemical composition of the mixture.
• Use of solvents other than water or aqueous ethanol (tincture) to make an extract.
• High temperature baking or cooking of an ingredient that has not previously been baked or cooked, unless the process causes only minor loss of volatile components with no other changes to the chemical composition of the ingredient.
• Changing the manufacturing method for an ingredient such that the chemical composition is significantly different (e.g., changes that alter the composition of materials used to make the ingredient, use of a different solvent, use of a chromatographic matrix instead of a passive filter).
• Application of nanotechnology that results in new or altered chemical properties of the ingredient.
• Changing agricultural or fermentation conditions to alter the chemical composition of the ingredient, such as by sprouting garlic or fermenting yeast using a medium containing large amounts of sodium selenite to create large amounts of organic selenium compounds.
• Fermentation using a fermentation medium different from the one used to make conventional foods in the food supply (e.g., use of a defined commercial growth medium to produce a microorganism previously made by fermenting milk into dairy products like yogurt or cheese).
• Use of a botanical ingredient that is at a different life stage than previously used (e.g., making an extract from unripe instead of ripe apples or using the mycelium instead of the fruiting body of a fungus.)

The guidance also states that if the manufacturing process alter the chemical composition or structure of an "old" dietary ingredient, the resulting compound is probably an NDI and an NDI notification to the FDA would be required.  For example, using a solvent to prepare an extract from a "old" dietary ingredient creates a NDI because the final extract contains only a fractionated subset of the constituent substances in the original dietary ingredient.  In addition, changes that alter the composition of materials used to make the ingredient, such as using a different part of a plant (e.g., using an extract of plant leaves where the root extract from the same plant is an "old" dietary ingredient), would create a NDI.

The 53-page guidance document could greatly impact your business.  It is recommended that you read it carefully and discuss it with your legal and regulatory team. 

The FDA is inviting the public to submit comments about the draft guidance.  Although you can comment on any guidance at any time, to ensure that the agency considers your comments on the draft guidance before it begins work on the final version of the guidance, you should submit your comments by October 3, 2011.

For more information: Federal Register Notice for New Dietary Ingredient Notifications and Related Issues (link for submitting comments; Docket ID: FDA-2011-D-0376): http://www.regulations.gov/#!documentDetail;D=FDA-2011-D-0376-0001.

FDA Issues New Labeling Rules for Sunscreen

After 33 years of consideration, the FDA today announced new labeling requirements for sunscreen OTC drug products.  The new requirements are effective June 18, 2012.  However, the compliance date for products with annual sales less than $25,000 is June 17, 2013.

Under the new rules, sunscreens must protect equally against UVB and UVA to earn the designation of offering "broad spectrum" protection.   UVB causes burns, and UVA causes wrinkles.  Both forms of radiation can cause skin cancer.

Products that have SPF values between 2 and 14 may be labeled "broad spectrum" if they protect against both UVB and UVA, but only those with a SPF value of 15 or greater may state that they reduce the risk of skin cancer and early skin aging.  Products that are not broad spectrum, or that are broad spectrum but which don't have an SFP of at least 15, will have to carry a warning stating that they have not been shown to help prevent skin cancer or early skin aging.

The new rules will also bar the use of the terms “sun block,” “waterproof” and “sweatproof."  Instead, sunscreens can be labeled as “water resistant” and must specify if they work for 40 or 80 minutes. Those that are not water resistant must carry a warning label advising people to use a water resistant product if they are going to be exposed to water or sweat.

The agency also proposed a new regulation that would limit the maximum SPF value on sunscreen labels to “50 +.”  The agency said there is insufficient evidence to show that products with SPF values higher than 50 provide greater protection than those with SPF values of 50.

Sunscreen makers could, however, submit data to support including higher SPF values.

In addition, the agency will begin accepting data about the safety and effectiveness of sunscreen sprays and comments on possible warnings for sprays.