Services

Little changes in language can make all the difference in claim compliance. I review product claims, website copy, social media posts, and marketing copy for compliance with FDA, advising on how to reduce risk while keeping your marketing language compelling.

Substantiation files support your product claims and allow you to confidently market your product. I bring together scientific and traditional use information to support your product’s claim, dosage, and safety.

I also prepare FDA claim notification letters.

Having a fully compliant label protects you and your product, helps you look good in the eyes of shoppers, and lets you be ready for any retailers you’d like to work with. Label regulations have a surprising number of details: required elements, font sizes, location of information, disclaimers, and more.

I’ll review all the details of your supplement, food, or cosmetic product to ensure that you’ve got all your “I”s dotted, your “T”s crossed, your net weight listed in the correct font size, and everything else.

I create nutrition fact panels and supplement fact panels for your labels. Working with lab testing results or an herbal formula, I’ll take care of any calculations needed to get all of the nutritional information and herbal ingredients listed correctly.

Regulatory training workshops are notoriously boring, but they don’t have to be.

I provide company-specific trainings on claim and marketing compliance that will leave your staff informed and inspired. Trainings can be tailored to cover dietary supplements, foods, or cosmetics.

If you’re feeling hesitant about the safety of a product or ingredient, I’ll take a look and give an expert opinion.

Similarly, if you’d like product-specific cautions for your label, including drug interactions and other cautions, I’ll put together a suitable caution statement.

Good caution statements keep your customers and your company safe.

In addition to substantiation files, I do GRAS dossiers, old dietary ingredient documentation, collections of interesting facts for your marketing team to use, and other research and writing.

Other areas of support and expertise include sourcing, quality control, adverse event reporting, and basic GMP compliance.

Need more? I partner with consultants specializing in DSHEA-compliant marketing and social media, GMP compliance, dietary supplement law, and related specialties to support the success of your business.