Band-Aid or Stitches? What's Your Compliance Approach?

When you get a deep cut, do you simply put on a band-aid or do you go to the hospital to get stitches that you really need? Stitches take time and are more costly - but, your bleeding will stop and your cut is less likely to re-open. With a band-aid - you're likely to re-open your wound and/or get an infection. You get stitches if you know what's good for you!

Compliance is similar in that there may be a quick fix for the current issue; however, if you don't stop the bleeding and get stitches, you will be in trouble in the long-run, and the bleeding won’t stop.

FDA Discusses TOP Reasons for Detention of Goods

At today’s Import Operations Training, sponsored by the U.S. Food and Drug Administration (FDA) and the Florida Customs Brokers and Forwarders Association (FCBF), top officials from FDA traveled to Miami to educate importers and brokers. Topics ranged from a general overview of FDA compliance, TOP rationales for FDA detentions, Food Safety and Modernization Act (FSMA) updates, an overview of the newly re-organized (now DIO) Division of Import Operations (formerly DIOP - policy has now been removed), an overview of CBP & FDA’s Joint Team 488 – which handles liquidated damages claims for underlying FDA violations and much more. Highlights of the TOP rationale for detentions follows, as I feel this is of most value to you to know and is arranged by commodity.

Food Products Top Rationales for Detention

•Manufacturer (processor, packer or person holding food product) is not registered with the FDA pursuant to the Bioterrorism Act. (You can Register with the FDA here: www.FDA-USA.com)

•Low Acid Canned Foods (LACF) are imported without establishment registration (FCE #) or scheduled process (SID #)

•The products are subject to an Import Alert

•Product labeling is not compliant (FDA does not pre-approve food labeling, it is up to importers to assure it is compliant before importing)

•Common labeling violations include:

1.Label is not in English

2.Incorrect or missing statement of identity

3.Failure to list allergens

4.Failure to declare ingredients

5.Failure to include a proper “Nutrition Facts” label (incorrect formats for Nutrition Facts labeling is also common) required by 21 C.F.R. 101.9

6.Color additives are not declared correctly (or at all) on the label or not certified

7.Food additives are unsafe or not declared on the label

Dietary Supplements Top Rationales for Detention

•The products are subject to an Import Alert

•Product labeling is not compliant (FDA does not pre-approve dietary supplement labeling, it is up to importers to assure it is compliant before importing)

•Common labeling violations include:

1. Label is not in English

2.Unauthorized health claims

3.Undeclared active ingredients

4.Lacks a “Supplement Facts” panel required by 21 C.F.R. 101.36

5.Failure to list the name of product and “Dietary Supplement” or “Herbal Supplement” on the label

6.Failure to list the appropriate disclaimer necessary when claims are made

Cosmetics Top Rationales for Detention

•The cosmetics are subject to an Import Alert (for example IA 66-38 for cosmetics labeled with drug claims)

•The cosmetics are contaminated and unsafe to use

•The cosmetics are manufactured under unsanitary conditions

•The cosmetics contain a non-permitted color additive

•Product labeling is not compliant (FDA does not pre-approve cosmetic labeling, it is up to importers to assure it is compliant before importing)

•Common labeling violations include:

1. Label is not in English

2.Labeling is missing ingredients

3.Label lacks warnings and adequate directions for use

4.Missing the net quantity of contents

5.Cosmetic contains a “drug” claim

Drugs Top Rationales for Detention

•The cosmetics are subject to an Import Alert (for example IA 66-41 – Unapproved new drugs)

•Drugs are not registered or listed with the FDA

•Product labeling is not compliant (FDA does not pre-approve drug labeling, it is up to importers to assure it is compliant before importing)

•Common labeling violations include:

1.Label is not in English

2.Label does not contain adequate directions for use

3.Active Pharmaceutical Ingredients (API) is not properly labeled or listed

4.Drug contains a “new” chemical or a different dosage making the product a “new drug”

Medical Devices Top Rationales for Detention

•The manufacturers is not registered with the FDA

•The initial importer is not registered with the FDA

•The device is not listed with the FDA

•The product does not contain a 510k or PMA

•Product labeling is not compliant (FDA does not pre-approve medical device labeling, it is up to importers to assure it is compliant before importing)

•Common labeling violations include:

1.Label is not in English

2.Label is false or misleading

Bottom line, as you can see, it is up to you, the importer to perform pre-compliance and assure you get compliance right before you import. FDA expects you to know the requirements and has little mercy if you don’t. Assure you stay compliant and avoid the top rationale for FDA to detain your goods by hiring someone that is extremely knowledgeable with FDA’s laws and regulations and continually stays up to date with the constant changes.  Contact me with any questions!