How to Find an FDA Labeling Consultant

Posted on by kginter
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As we’ve blogged about before, we understand the confusion when it comes to FDA labeling compliance. A few weeks ago we received a comment asking for assistance in finding a good FDA labeling consultant. I thought about this question and said to myself “I bet there are a lot of people out there looking for a label consultant.” So here, my friends, are the deets on what to look for in a label consultant and what you should consider in deciding whether you need a label consultant.

What is an FDA Label Consultant?

Labeling rules can vary by size of the product and by the product container, can get as complicated as understanding whether there are mandatory type sizes for the text on your label, or required declarations that have to be printed in specific areas on your label.

You might not want the responsibility of verifying all of that information on your own.

An FDA label consultant is someone who is there to support your goal towards having an FDA compliant label. Their job is to be the expert on what can and cannot be printed on a product label. Each type of product is labeled under a different set of regulations, so if you have a complex product line, a label consultant can take help you understand how to comply with numerous sets of rules.

Do You Need an FDA Labeling Consultant?

Steve Zoller, president of consulting firm Food Label Consultants, advised that “Anyone just starting in the food business should have their labels reviewed.”

Barb Bennett, president of the International Meat Inspection Consultants, Inc., (IMIC), advises those who do not have the time to learn about labeling laws to use a labeling consultant.

Bennett explained, “If you have multiple products that you are producing or importing and do not have the time, energy or desire to review the labels for compliance, I would suggest you seek out a consultant to assist you in reviewing labels or assisting in the design of labels for compliance.”

We were able to get insight from a medical device company experienced with FDA label compliance, EXACTA Dental Direct. Chase Wade, Director of Operations, weighed in on why his company uses a qualified label consultant and why he advises others to use one.

“My advice to another small business going through FDA label pains is to find a qualified consultant and do exactly what they tell you to do. I know this sounds a little callous, but there are too many regulations that are under constant change in order for most small business to keep up.” Wade added, “It is a pricey solution, but less than having a world of hurt thrown down on you by a FDA regulator.”

Zoller explained that once a brand has an established product line and has had its original labels reviewed, “adding new SKUs should be routine as long as they are the same size package and similar ingredients.”

Voluntary food claims such as “low fat” make label compliance more complicated, according to Zoller. If you print your label claim incorrectly it’s not just the FDA you have to watch out for. “It’s important that these statements comply with the law. If you’re not compliant, even if the FDA doesn’t notice, your competitors will,” Zoller advised.

That’s a great point.

Even if your competitor makes certain claims, that doesn’t mean that you should. “Consultants advise on what complies, not what sells in the marketplace.” Some claims do fly under the FDA’s radar, but not for long. “Brands that step beyond the law do so at their own risk,” said Zoller.

“By nature, consultants will be conservative and render advice that clearly keeps the client within the law” Zoller added.

Do you use a co-packer? If so, Zoller said that some co-packers may be experienced enough to advise on compliance, while others may not want the liability. This may be something you want to consider when researching a co-packer.

How much does an FDA labeling consultant cost?

Consulting rates vary from company to company.

According to Bennett, IMIC’s general label review starts at $32.50 and up. Bennett says IMIC charges on a per label basis, whereas other companies may charge by the hour.

Zoller’s Food Label Consultants charge by the hour and costs vary depending on the product. He was kind enough to give us some cost examples: “A simple label, such as olive oil, takes little time and will probably cost $150.”

But on the other end of the spectrum, “A product with many ingredients, various claims, lots of romance language, and an odd container will take much more time and could be as much as $400-$500,” he said.

What services do label consultants offer?

Barbra Bennett described her company’s food label compliance services as offering USDA expediting services for the review of USDA labels and submittal to USDA for approval. Bennett also included review of domestic and imported non-meat/poultry products for regulatory compliance, nutritional labeling, and training in labeling basics. The complete list can be found at IMIC’s website:

  • Allergen statements
  • Child Nutritional labeling
  • Ingredient statements
  • Nutrition facts panels
  • Product claims (i.e. low fat or whole grain)
  • USDA expediting services
  • Training in label basics

Food Label Consultants offers complete label reviews for compliance with 21CFR101 Food Labeling, Nutrition Facts using a database program. They also review for dietary supplements and for non-foods as well, according to President Steve Zoller. On their website, they highlight consulting for the following federal regulations:

  • Allergen Statements
  • Health Claims
  • Ingredient Acceptability
  • Label Layout
  • Nutrient Claims
  • Organic Compliance
  • Statement of Identity (Product Name)

More Resources to Help You Find an FDA Labeling Consultant:

Food Label Consultants

International Meat Inspection Consultants (IMIC)

Manual of FDA Compliance Policy Guidelines

 

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