Cosmetics

On June 9, 2016, the U.S. Customs and Border Protection (CBP) hosted a webinar on filing import entries through the Automated Commercial Environment (ACE) portal.  The webinar was organized by the U.S. Food and Drug Administration (FDA) and the National Customs Brokers and Forwarders Association of America (NCBFAA).

What is ACE?

Customs brokers and self-filing importers must file information with CBP and other agencies regarding products they import into the United States. CBP describes ACE as “the primary system through which the trade community will report imports and exports and the government will determine admissibility.” CBP and FDA, along with 46 other government agencies, have partnered to make ACE a single window for submitting all data required by the agencies.  ACE will replace ACS, the current commercial database used to submit data through CPB to FDA.

Compliance Dates

June 15, 2016 is the date when ACE is to become the sole filing system for the following FDA entry types:

• 01 – Consumption – Free and Dutiable
• 03 – Consumption – Antidumping/Countervailing Duty
• 06 – Consumption – Foreign Trade Zone (FTZ)
• 11 – Informal – Free and Dutiable
• 23 – Temporary Importation Bond (TIB)
• 51 – Defense Contract Administration Service Region (DCASR)
• 52 – Government – Dutiable

While June 15 acts as the mandatory filing date for these FDA entry types, CBP is allowing a sort of learning period through July 23, 2016.  Entries filed through ACS after June 15 will likely be allowed, but the consequences will be decided on a case-by-case basis.  Users may receive a warning message.  CBP may also follow up with ACS filers to see why they are not filing through ACE and to determine how CBP can assist in the transition to ACE.  Come July 23, ACS will no longer be allowed as an alternate filing method.

Common Errors when Filing in ACE

During the webinar, FDA revealed some of the most common errors and causes for entry rejection made when filing entries through ACE.

• Filers must provide a valid prior notice confirmation number for food and beverage shipments. Filers should only include the confirmation number and not the other FDA data required to file prior notice. Many filers submit invalid prior notice confirmation numbers.
• Many filers fail to provide a valid FDA registration number. (Tip: FDA requires food facilities to renew their FDA registration between October 1 and December 31 of each even-numbered year. Registrations not renewed as required are considered expired by FDA.)
• Many entries are rejected for a missing or invalid product code, affirmation of compliance code, or intended use code.
• Many filers include mismatching entity IDs. For example, an entry for a processed food must list a manufacturer code (as opposed to a grower code) as the entity ID.
• Many filers include mismatching source type codes. Entries for imports from growers or consolidators must list a country of growth, while entries for imports from manufacturers of processed foods must list a country ofproduction. Both types of entries must also include a country of shipment.
• Many filers list a foreign country as the ultimate consignee for non-food items. This is incorrect, as the ultimate consignee is meant to represent the final destination where the product will be delivered within the United States.

These are but a few of the mistakes made when filing entries within ACE.  FDA offers assistance with ACE entries at[email protected]. FDA ACE support will be available 24/7 beginning sometime this month.  FDA also provides this chart for identifying required data elements for entries of FDA-regualated products.

If you notice a mistake in an ACE entry, you may submit corrections up to 5 days before a shipment’s expected arrival to the United States.  Once the shipment is within 5 days of its expected arrival, no corrections may be made unless FDA rejects the entry.

Speeding Up Your Imports

It’s prudent for brokers and importers to begin filing their entries through ACE as early as possible, as ACE provides the quickest entry. According to FDA, the agency is actively prioritizing ACE entries over those filed through ACS.  Entries filed through ACE are processed two times faster.

While DUNS and FEI numbers are not currently required for filing entries of most commodities in ACE, FDA noted that including this data may expedite the processing of an entry.  “Providing a DUNS number gives FDA a higher confidence level in looking at that data,” the agency said during the webinar regarding confirming the name and address of a product manufacturer.

How Registrar Corp can Assist

Registrar Corp offers a variety of services to help brokers obtain the information they need to file entries in ACE.  Registrar Corp can:

• Register facilities with FDA and provide Certificates of Registration documenting a facility’s valid FDA registration number.
• Submit Prior Notice to FDA for food and beverage shipments and obtain a Prior Notice confirmation number.
• Obtain DUNS numbers for facilities at no cost.
• Help identify valid FDA product codes and Affirmation of Compliance codes.

Registrar Corp’s FDA Compliance Monitor also acts as a valuable resource for custom brokers and importers.  The monitor provides detailed information on monitor facilities, such as a facility’s DUNS number (when available) and any FDA Warning Letters, Import Alerts, Import Refusals, and Inspection Classifications tied to the facility.

For more information on filing FDA-regulated entries in ACE, regulations for importing FDA-regulated products to the United States, or how Registrar Corp can assist, contact +1-757-224-0177.  Live help is available 24-hours a day at regstaging.wpengine.com/livehelp.

Registrar Corp is often asked about how to obtain U.S. Food and Drug Administration (FDA) approval for a variety of products.  While FDA has extensive regulations for food, drugs, medical device, and cosmetics marketed in the U.S., many products do not require FDA approval.  In fact, in some cases it’s a prohibited act to claim that FDA has approved a product.  To address common misconceptions, Registrar Corp put together a guide to what products do and do not require FDA approval.

Food

FDA does not approve food, beverages, or dietary supplements.  Food facilities do not have to obtain any type of certification or approval before distributing products in the United States.  Food facilities are required to register with FDA, but being registered with FDA does not indicate approval of the facility or its products.

FDA does approve new food additives.  If a manufacturer wishes to use a new food additive in his product, he will need to put the additive through appropriate testing and prove to FDA that the additive is safe.

Drugs

Whether or not a new drug product requires FDA approval depends on whether the new drug conforms to an over-the-counter (OTC) monograph.  OTC monographs establish conditions under which FDA has pre-determined a drug will be safe and effective.   Once an OTC monograph is final, drug establishments can market OTC drugs that conform to the monograph without FDA approval.  FDA also uses enforcement discretion to allow certain drugs to be marketed without approval if they conform to tentative final monographs.

If a new drug does not comply with a monograph, it will require FDA approval.  Drug manufacturers must conduct lab, animal, and human clinical testing and submit their data to FDA.  FDA will then review the data and may approve the drug if the agency determines that the benefits of the drug outweigh the risks for the intended use.  Marketing a new drug that does not conform to an OTC monograph without FDA approval is considered as marketing an unapproved new drug, which is a prohibited act under the Food, Drug, and Cosmetic Act (FD&C Act).

Though FDA approves new drugs, the agency does not approve compounded drugs. Drug establishments must register with FDA and list their products, but neither registration nor listing indicates approval of the establishment or its products.

Medical Devices

FDA places medical devices into one of three risk-based categories: Class I, Class II, and Class III.  Class III devices are the highest-risk devices and the only devices that require FDA premarket approval.  Manufacturers of Class III devices must demonstrate to FDA that the device provides reasonable assurance of safety and effectiveness.

Class I and II devices do not require premarket approval.  These devices, unless exempt under the FD&C Act, must submit premarket notification (510(k)) to FDA instead.  The purpose of a 510(k) is to demonstrate to FDA that the device is substantially equivalent (as safe and effective) to an already legally marketed device.  If FDA determines that the device is indeed substantially equivalent to a legally marketed device, the agency clears the product for marketing rather than approving it.

Device establishments must register with FDA and list their devices, but neither registration nor listing indicates FDA approval of the establishment or its devices.

Cosmetics

FDA does not require approval of cosmetic products and their ingredients (other than color additives) before marketing.  Cosmetic companies are not required to register with FDA, but cosmetics do have to be safe for their intended use.

It’s important to be aware that certain claims made in cosmetic labeling can cause FDA to regulate a cosmetic product as a drug.  In some cases, this could cause the product to require FDA approval.

Color Additives

FDA does approve color additives used in food, drugs, cosmetics, and some medical devices.  Certain high-risk colors also require FDA color batch certification of every individual batch.   Color additives may only be used in compliance with their approved uses, specifications, and restrictions.  Products that contain unapproved color additives are considered to be adulterated under the FD&C Act.

Manufacturers of drugs and devices that do require approval may include the phrase “FDA Approved” on the product’s labeling, as long as the manufacturer has received a letter from FDA confirming its approval.  The FDA logo should not be used on a product’s labeling whether the product is approved or not.  Use of the FDA logo could imply that the product is endorsed by FDA, therefore unauthorized use of the logo may violate federal law.  Manufacturers who use FDA’s logo on their product labeling may be subject to civil or criminal liability.

Whether their products require FDA approval or not, food facilities, drug establishments, device establishments, and cosmetic companies must adhere to FDA’s Current Good Manufacturing Practices (CGMPs) and extensive labeling requirements. For those products that do require approval, such as certain drugs and devices, labeling is approved when the product is approved.  However, labels are not generally subject to FDA approval.

You may be wondering how FDA enforces its requirements when so many products do not require premarket approval.  FDA enforces its requirements through routine facility inspections and randomized shipment inspections at the U.S. border.

Registrar Corp helps food, drug, medical device, and cosmetic companies comply with U.S. FDA regulations.  Registrar Corp can register a company with FDA, list its products with FDA, and review product labels for FDA compliance.  Registrar Corp can also help submit color additives to FDA for color batch certification.  For any questions regarding FDA regulations, or to learn more about how Registrar Corp can assist, contact +1-757-224-0177 or chat with a Regulatory Advisor 24 hours a day at regstaging.wpengine.com/LiveHelp.

All color additives must be approved by the U.S. Food and Drug Administration (FDA) before they are used in food, drugs, cosmetics, or medical devices that come in contact with a human or animal body for a significant period of time.  What many people don’t realize is that many of these color additives also require color batch certification, which is obtained by sending a sample of a batch of color to FDA for testing.

Highly synthetic color additives have a higher risk of contamination than other additives.  These additives, for which the U.S. name begins with “FD&C” or “D&C”, are subject to color batch certification.  Color batch certification must be obtained for every individual batch of color by sending a four ounce sample of each batch to FDA.  FDA will then test the sample to ensure any contaminants contained in the batch, such as lead or arsenic, do not exceed the amount allowed.

The fee for color batch certification is based on the weight of the batch.  For straight colors, the fee is $0.35 per pound with a minimum fee of $224. The fee is nonrefundable despite whether the color batch passes or fails the certification testing.

When purchasing a color additive for use in a product that will be sold in the U.S., the purchaser should check to see if the additive requires color batch certification.  If so, the purchaser should request proof of certification before purchasing the additive.  It’s important to use the U.S. name of a color additive when researching whether or not it requires color batch certification.  For example, a commonly used color additive is named “sunset yellow” in Europe.  “Sunset yellow” translates to “FD&C Yellow #6” in the U.S., a color which requires certification.  Similarly, the commonly used additive “Allura Red” is named “FD&C Red 40” and is another that requires certification.

If FDA certifies a color batch, the agency will send the manufacturer a certificate with a lot number.  If a product is shipped to the U.S. and it contains a color additive that requires certification, FDA may contact the owner or his U.S. Agent and ask for the lot number of the color batch.  If the contact cannot provide a valid lot number, the product may be deemed adulterated and may not be allowed into the United States.

FDA has published an import alert for companies with a history of shipping foods that contain illegal color additives, including those that are uncertified.  Any company on the import alert will have its products detained without physical examination at the U.S. border.  It’s important to comply with FDA’s color batch certification requirements to avoid the delays associated with being on an import alert.

For guidance on FDA’s requirements for a specific color additive, or to submit a sample for color batch certification, contact Registrar Corp.

About the Author:  David Lennarz is Vice President of Registrar Corp, an FDA compliance firm located in Hampton, Virginia, USA.  Lennarz served as a Technical Expert for FDA’s Foreign Facility Registration Verification Program and has conducted seminars on U.S. FDA regulations in more than 30 countries around the world.

According to U.S. Food and Drug Administration (FDA) records obtained by Registrar Corp through a Freedom of Information Act request on October 20, 2014, FDA received approximately 368 petitions to be removed from an import alert red list in 2013. This may seem like a substantial amount, but there are approximately 13,000 companies currently on FDA import alert red lists. Along with this, only 165 companies petitioned to be added to an import alert green list in 2013.

What is an Import Alert?

An import alert occurs when FDA determines a pattern of non-compliance from a specific company, country, or a specific type of product. Products that fit the criteria of an import alert are subject to Detention Without Physical Examination (DWPE). Products subject to DWPE will be detained at the U.S. border without being examined by FDA. The importer or exporter of the product must then prove to FDA that the shipment is compliant in order for the product to be released into the United States.

What are red and green lists?

A red list contains all the companies that FDA has specifically identified as having a history of violation and are therefore subject to DWPE under a certain import alert. For example, FDA Import Alert 45-02, “Detention Without Physical Examination and Guidance of Foods Containing Illegal and/or Undeclared Colors,” currently lists approximately 1,750 unique companies with products to be detained when shipped to the United States.

When an entire product type or region has a history of violation, FDA may create an import alert to cover all shipments of that product or from that region. These broad import alerts may have a green list, a list of companies that meet the criteria of an import alert, but have proven they are suitable for exclusion from DWPE. For example, FDA noticed a pattern of adulteration in shrimp coming from India in 1979. In response, FDA created Import Alert 16-35 to cover all shipments of raw and cooked shrimp from all manufacturers in India. An Indian facility can, however, petition FDA to be added to the green list of this import alert if it is able to prove that adulteration will not be a concern with its products.

Petitioning for removal from an Import Alert

When a company finds its products are subject to DWPE due to an import alert, the company can petition to be removed from a red list or added to a green list, whichever is relevant for the particular alert. The petition process typically has three steps:

1. Acompany must analyze its business to determine whether adequate preventive controls or corrective actions are in place to remove the appearance of violation.
2. The company will need evidence that its preventive controls or corrective actions are effective over a reasonable period of time. At minimum, FDA will require proof of five to twelve cleared, non-violative shipments of the product on import alert to the United States.
3. Lastly, the above evidence must be organized into a petition and submitted to FDA’s Division of Import Operations.

So why do such a small percentage of companies on import alert petition FDA? Many companies simply don’t know that petitioning is an option. For those that do, many are intimidated by the petitioning process. Import alert petitions are often extensive and complicated, requiring hundreds of pages of supporting documents. Though it’s a daunting process, petitioning FDA is worth it for most companies. Dealing with detentions can be a huge expense for companies, both directly and indirectly, and can stress the relationship between an exporter and importer. Companies often go through the petition process even if they don’t ship to the United States because they feel that being listed on an FDA import alert may negatively affects their corporate image and brand.

Registrar Corp Regulatory Specialists are highly experienced in obtaining and properly organizing the necessary documentation required for a successful import alert petition, and can assist companies on import alert through the petition process. For assistance with import alerts and detentions, contact Registrar Corp at +1-757-224-0177 or speak with a Regulatory Specialist 24 hours a day at: https://regstaging.wpengine.com/LiveHelp.

This blog was originally published as a press release.