Labeling: Antimicrobial vs Antibacterial

https://www.cdpr.ca.gov/docs/schoolipm/school_ipm_law/differences_antimicrobial_gpc.pdf

Antimicrobial

Antimicrobial products kill or slow the spread of microorganisms. Microorganisms include bacteria, viruses, protozoans, and fungi such as mold and mildew.

The U.S. Environmental Protection Agency (EPA) regulates antimicrobial products as pesticides, and the U.S. Food and Drug Administration (FDA) regulates antimicrobial products as drugs/antiseptics. As pesticides, antimicrobial products are used on objects such as countertops, toys, grocery carts, and hospital equipment. As antiseptics, antimicrobial products are used to treat or prevent diseases on people, pets, and other living things.

If a product label claims to kill, control, repel, mitigate or reduce a pest, it is a pesticide regulated by the U.S. EPA.  If a product shows “EPA” anywhere on the label, you know it’s a pesticide and NOT meant for use on the body.

Sanitizers are the weakest public-health antimicrobials. They reduce bacteria on surfaces.

Antimicrobial substances offer a greater level of product protection by continuously inhibiting the growth of microbes on surfaces for very long periods of time.

Antimicrobial Claims

Most Advantus product is marketed to support a hygienic environment.  The below outline a few best practices:

• Ensure if you are making an antibacterial claim that there is study to support the claim of qualified  bacteria
• Ensure there is no claim of “antimicrobial” activity.  Unless the product is a registered disinfectant or pesticide, it should not be marketed to kill or reduce germs/bacteria.
  • e.g., The nature of cleaning reduces germs, not our products specifically. Cleaning with SurfaceKleen helps reduce germs.
• Treated article claims:
  • Claims should be limited to protection of the article itself
    • e.g., Mold and mildew control:
      • controls odors
      • may inhibit growth of microorganisms that cause spoilage of the item
  • Avoid “allergen” claims
• If concern about a specific target audience arises with sale of a product, consider a disclaimer, e.g., “This product does not protect users or others from bacteria, viruses, germs, or other disease-causing organisms.”
• Consider intended customers and ability to interpret claims.
  • how “sophisticated” is the intended customer

Contact Legal for further assessment to register with EPA if:

• Implied or explicit public health claims
• Claims for protection extends beyond the article itself  e.g., treated container inhibits growth of bacteria

Antibacterial

Antibacterial technologies are effective against a broad spectrum of harmful bacteria including E. coli and MRSA.* They will typically incorporate silver active ingredients, allowing for successful application in a wide variety of product types.

Rules and Regulations

Consumer Product Safety Commission (CPSC) : General Household Cleaning Products, Hazardous Substances

Environmental Protection Agency (EPA): Pesticides

The mission of EPA is to protect human health and the environment.  In order to know if you require EPA registration, it is necessary to know what the law defines as a pesticide.  The term pesticide, as defined in FIFRA section 2(u) means:

1. any substance or mixture of substances intended for preventing, destroying, repelling, or mitigating any pest;
2. any substance or mixture of substances intended for use as a plant regulator, defoliant, or desiccant; and
3. any nitrogen stabilizer

Federal Trade Commission (FTC): Advertising, Labeling

US Food and Drug Administration (FDA) : Drug products, Medical devices

Claims and Regulations

Asking the following questions will typically get you to proper regulatory classification:

• How are the claims worded?
• How does the product function?
• What will the product be used on?

Drugs/Cleaning Wipes

Cleansing wipes are made of materials such as polyester, polypropylene, cotton, wood pulp, or rayon fibers formed into sheets. They may be packaged individually, or in small or bulk packaging. They are moistened with water and other ingredients, such as cleansing and moisturizing agents that help them work. They may contain other ingredients, such as preservatives to prevent the growth of bacteria and molds.

Skin Cleanser	Surface Cleaner	Antibacterial – Skin	Antibacterial – Surface
Wipes intended for cleansing or moisturizing the skin, such as those for baby care, hand washing, makeup removal, washing the body when bathing is not practical, feminine or other personal cleansing.	Wipes intended for cleansing objects in our homes, at work, the gym, and in public spaces. Cleaning Products	Wipes intended for a therapeutic purpose, such as killing germs on the skin, treating acne, diaper rash or other skin conditions, are drugs under the law.	Wipes intended to control germs on inanimate surfaces (disinfect or sanitize) and wipes containing insect repellents.
FDA Regulated	CPSC Regualted	FDA Regulated	EPA Regulated
https://www.fda.gov/cosmetics	https://www.cpsc.gov/	http://fda.gov/drugs	http://eps.gov
No market approval required.	Review product labeling requirements.	Market approval required. Products, such as hand sanitizing wipes, that claim they are improving your health are required to have an NDC number on the label.	EPA registration required. Hard surface sanitizing wipes only reduce 99.99 percent of bacteria on surfaces in 30 seconds to 5 minutes. They are required to pass the Official Detergent Sanitizer Test (sometimes knows as the Weber and Black Test) to back up the bacteria kill claims made on the product label.

Note:  The FD&C Act defines cosmetics as articles intended to be applied to the human body for cleansing, beautifying, promoting attractiveness, or altering the appearance without affecting the body’s structure or functions.  Therefore, hand cleaning wipes are regulated as cosmetics.

Process for Label Reviewing

Prior to implementing any website copy, product packaging, or any product advertisement, all claims made on Advantus cleaning products must first be reviewed and approved by the Advantus Compliance Department and the Product Compliance Specialist before being sent to the Legal Department for final approval.