Dietary Supplement Labeling Lessons

Dietary supplement labeling can be confusing, but I’ll run through some key issues from a recent warning letter today.

Address or Phone Number

From warning letter.  “The label fails to bear a domestic address or domestic phone number through which the responsible person (as described in section 761) may receive a report of a serious adverse event with such dietary supplement.”

Asa Comments: This safety requirement is the core of the supplement industry, as it gives consumers a way to report adverse events to the brand holders. These complaints are investigated, and serious adverse events are then reported to FDA.

Common or Usual Ingredient Names

From warning letter. “The product labels fail to declare all the common or usual names of each ingredient used as required by 21 CFR 101.36 and 21 CFR 101.4.”

Asa Comments: For example, if the company only listed a branded ingredient name, this would not be sufficient and descriptive.

Weights Above 1000mg

From warning letter. “Product fails to express the quantitative amount by weight per serving of the Proprietary Blend …” using metric measures in appropriate units (i.e., 1000 units must be declared in the next higher set of units, e.g., 1,100 mg must be expressed as 1.1 g), as required by 21 CFR 101.36(b)(3)(ii)(A)”

Asa Comments: Okay, this is not really high risk, but it is always better to be compliant. If items without a %DV are present at 1000 mg or more, they should be listed in grams rather than milligrams. I’ve seen companies list the amount in grams, then list the milligrams in parentheses. I don’t think this is compliant, but I haven’t seen it cited in a warning letter.

From warning letter. “Products’ proprietary blends fail to declare the quantitative amount by weight totaled from the weight of all the dietary ingredients contained in the proprietary blend, as required by 21 CFR 101.36(c)(3);”

Asa Comments: This is pretty obvious. The amounts of ingredients should be listed on the label.

Statement of Identity

From warning letter. “The label fails to identify the product by using the term “dietary supplement” as a part of the product’s statement of identity, as required by 21 CFR 101.3(g).”

Asa Comments: This is a crucial part of a supplement label. If accurate, “Herbal Supplement” would be compliant, whereas “Sleep Supplement” would not.

DHSEA Disclaimer

From warning letter. “The labeling makes structure-function claims but fails to bear the required dietary supplement disclaimer in accordance with 21 CFR 101.93(b)-(d).”

Asa Comments: This is only required when products make structure-function claims, and according to regulations, the disclaimer should be on every label panel where claims occur.  FDA does not seem to enforce the “every label panel” rule, but there are numerous lawsuits about this.

Net Quantity of Contents

From warning letter. “The labels fail to accurately declare the net quantity of contents on the principal display panel (PDP)”

Asa Comments: This is an essential element of supplement labels such as “60 Capsules” or “1 FL OZ (30mL)” or “Net Wt. 5.5OZ (155.9g).”

To be fair, this company likely received the warning letter due to serious GMP violations, such as FDA stating that the “management could not provide any documentation that you are performing any quality control operations for receiving, packaging, labeling, holding, and distributing your dietary supplements, including approving and releasing product for distribution.” The company was also involved in a yellow oleander-related recall, which really speaks to why specifications and GMPs are an essential part of a safe supply chain. More on this in a future post.

Read the full warning letter here.