Listing Cologne On Amazon: Fda Compliance Simplified

If you want to list a cologne as FDA-compliant on Amazon, you must ensure that it complies with FDA regulations for labelling, ingredients, and claims. This includes registering your facility with the FDA and ensuring that your product labels are in English and comply with FDA labelling requirements. Additionally, you may need to provide an FDA Registration screenshot to Amazon.

FDA registration for Amazon sellers

If you are an Amazon seller, you must comply with FDA regulations for labelling, ingredients, and claims. To register with the FDA, you must first visit the FDA website. You will need to obtain a DUNS number and an employer identification number (EIN) from the U.S. Internal Revenue Service (IRS).

If you are a foreign business, you will need an EIN when filing U.S. Customs paperwork and registering with the FDA. Obtaining an EIN can be complicated for non-U.S. businesses, so it is recommended to seek assistance from specialists.

Additionally, importers of food, beverages, and dietary supplements into the United States are required to have a Foreign Supplier Verification Program (FSVP) to verify that the products meet U.S. safety standards. You must also designate an FSVP Agent, who must be a "qualified individual" located in the U.S. to serve as the importer's representative with the FDA.

For dietary supplements, you will need to provide an FDA Registration screenshot. This can be found by logging into the FDA website and accessing your account. From there, you can navigate to the Food Facility Registration page and display all the Food Facility registrations under your account.

It is important to note that labelling claims must comply with FDA regulations. A claim is any representation made about a product on the label, website, flyer, or even social media. Specialists can help review your claims and ensure they meet FDA compliance.

By following these steps and working with specialists, you can ensure that your products comply with FDA regulations and are properly registered for sale on Amazon.

FDA labelling requirements

The FDA is responsible for ensuring that foods sold in the United States are safe, wholesome, and properly labelled. This includes cosmetics, which are defined as articles intended to be applied to the human body for cleansing, beautifying, promoting attractiveness, or altering appearance without affecting the body's structure or functions. This includes perfumes and colognes.

Cosmetics marketed in the United States, whether manufactured in the US or imported, must comply with the provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and the Fair Packaging and Labeling Act (FPLA). The FD&C Act prohibits the distribution of cosmetics that are adulterated or misbranded. A cosmetic is misbranded if its labelling is false or misleading, if it does not bear the required labelling information, or if the container is deceptive. The labelling requirements are codified at 21 CFR 701 and 740.

Cosmetics labels must include the name of the product, the nature or use of the product, and a statement of the net quantity of the contents. The name and place of business of the firm marketing the product must also be stated on an information panel of the label. If the distributor is not the manufacturer or packer, this must be stated on the label. The label statements required under the FD&C Act must appear on the inside and outside container or wrapper.

Additionally, cosmetics produced or distributed for retail sale to consumers for their personal care are required to bear an ingredient declaration. In most cases, each ingredient must be listed individually. However, under US regulations, fragrance ingredients can be listed simply as "Fragrance." This is because fragrance formulas are often considered trade secrets.

It is important to note that products that are cosmetics but are also intended to treat or prevent disease, or affect the structure or functions of the human body, are considered drugs and must comply with drug provisions as well.

Regarding selling cologne on Amazon, it appears that Amazon requires verification of FDA registration for certain product categories. This verification can be provided through a screenshot of the registered facility from the FDA website. However, it is important to note that the FDA does not issue certificates of registration.

FSMA and food safety

The Food Safety Modernization Act (FSMA) is a United States federal legislation that aims to ensure the safety of the country's food supply by shifting the focus from responding to foodborne illnesses to preventing them. The FSMA was signed into law by President Barack Obama on January 4, 2011, and has given the Food and Drug Administration (FDA) new powers to regulate the way foods are grown, harvested, and processed.

The FSMA has been described as the first major piece of federal legislation addressing food safety since 1938 and the first to address intentional adulteration and Food Defense. It was prompted by numerous incidents of foodborne illnesses during the first decade of the 2000s, which cost the food industry billions in recalls, lost sales, and legal expenses.

The FSMA has transformed the nation's food safety system by implementing several rules that recognise ensuring food safety is a shared responsibility across the global supply chain for both human and animal food. The Act's rules are designed to outline specific actions that must be taken at each point in the supply chain to prevent contamination.

FSMA Rules

• Produce Safety
• Pre-Harvest Agricultural Water
• Accredited Third-Party Certification
• Food Traceability
• Foreign Supplier Verification Programs (FSVP) for Importers of Food for Humans and Animals
• Laboratory Accreditation for Analyses of Foods (LAAF)
• Mitigation Strategies to Protect Food Against Intentional Adulteration
• Preventive Controls for Human Foods
• Preventive Controls for Animal Food
• Sanitary Transportation of Human and Animal Food

FSMA's Impact on Food Safety

The FSMA has provided the FDA with new tools for inspection and compliance, as well as a clear regulatory framework to improve their approach to food safety. For the first time, the FDA has a legislative mandate to require comprehensive, science-based preventive controls across the food supply chain, including pet food and animal feed.

The Act also enhances the FDA's ability to oversee the millions of food products imported into the United States annually, with the recognition that about 30% of the population is at risk for foodborne illnesses, and over 14% of the food supply is imported.

The FSMA has also established a system of collaboration with other government agencies, both domestic and foreign, to achieve public health goals.

Trademarks

To list a cologne as FDA on Amazon, you must first ensure that your product is eligible for Amazon Brand Registry. This requires that your brand has an active registered trademark in each country where you wish to enroll, or a pending trademark application filed through Amazon IP Accelerator, or a pending trademark application filed in a subset of trademark offices. The trademark for your brand must be in the form of a text-based mark (word mark) or an image-based mark with words, letters, or numbers (design mark).

The trademark text must match the brand name on the application. If your trademark is an image-based mark with words, letters, or numbers, you will need to upload a copy of the image as it appears on your trademark record. This trademark must also appear on your products or packaging.

The trademark owner must submit the Brand Registry application. If you are an authorized agent, the trademark owner must enroll the brand first, and then you can be added as an additional user.

Once you have submitted the application, Amazon will verify that you are the Rights Owner of the trademark and will reach out to a contact that meets their requirements. This person will receive a verification code, which must be sent back to Amazon to complete the enrollment process.

After Amazon has verified the provided information, you will get access to the full suite of Amazon Brand Registry’s benefits and features that help you protect your brand.

It is important to note that these guidelines are specific to trademarks owned by Amazon.com, Inc. or its affiliates. Strict compliance with these guidelines is required, and any violation will automatically terminate any license related to your use of the trademarks.

Foreign Supplier Verification Program

The Foreign Supplier Verification Program (FSVP) is a program that importers of food products in the United States, covered by the rule, must have in place to verify that their foreign suppliers are producing food in a manner that provides the same level of public health protection as the preventive controls or produce safety regulations. The program was established by the FDA on November 16, 2015, with the first compliance date set for May 30, 2017.

The FSVP requires importers to verify that their foreign suppliers of food for human and animal consumption meet applicable FDA safety standards. This includes ensuring that the food is not adulterated, properly labelled with respect to allergens, and that the production processes and procedures offer the same level of public health protection as the preventive controls requirements in the preventive controls and current good manufacturing practices rules for human and animal food.

The specific responsibilities of importers with respect to food safety under the FSVP include:

• Determining known or reasonably foreseeable hazards with each food
• Evaluating the risk posed by a food, based on the Hazard Analysis, and the foreign supplier’s performance
• Approving suppliers and determining appropriate supplier verification activities based on the risks posed by an imported food and the supplier’s performance
• Conducting supplier verification activities
• Conducting corrective actions for deviations and discrepancies

Importers must establish and follow written procedures to ensure that they import foods only from foreign suppliers approved based on an evaluation of the risk posed by the imported food and the supplier’s performance. If necessary, on a temporary basis, importers may import from unapproved suppliers, but the food must be subjected to adequate verification activities before being imported.

The compliance dates for FSVP are staggered based on the size of the foreign supplier and the regulations that apply to the foreign supplier. The first compliance date is 18 months after the FSVP final rule was published in the Federal Register, giving importers time to understand the rule and develop their FSVPs. After that, importers generally have to comply within six months of their foreign supplier having to comply with the PC or produce safety rules.

Importers who are also manufacturers/processors are deemed in compliance with most FSVP requirements if they are in compliance with the supply-chain program requirements under the preventive controls rules, they implement preventive controls for the hazards in the food, or they are not required to implement preventive controls under certain circumstances.

There are also modified FSVP requirements for certain importers, including dietary supplement importers and very small importers.

Frequently asked questions