Pressure sensitive stickers are as a means for manufacturers to use existing labeling material by covering inaccurate and/or misleading labeling information with corrected text or used as a promotional tool, e.g., a starburst encircling sweepstakes terminology. A pressure sensitive sticker must be the type that destroys the underlying label or package if removed, or be self-destructive. Similarly, indelible ink is used as a means for manufacturers to use existing labeling material by covering inaccurate and/or misleading labeling information with opaque ink or adding required information with a rubber stamp.

Temporary label approval is not required when the entire label including the pressure sensitive sticker or marking/covering from indelible ink is truthful, not misleading, and the product is not misbranded. Corrected text on pressure sensitive sticker can cover mandatory or non-mandatory information. Indelible ink may be used to cover inaccurate information or apply markings to existing labeling material in order to make the labeling accurate and truthful.

Labeling bearing pressure sensitive stickers or marking/covering from indelible ink falls under the provisions of the generic label approval regulations in 9 CFR 317.5 and 9 CFR 381.133, which provides the conditions for use of final labeling without first submitting sketch labeling for evaluation and approval at headquarters. Companies need to create and maintain records of all final labeling, otherwise known as generic approvals.

Consistent with the rules on generic labeling approval, sketch labeling approval is required for the entire label when pressure sensitive stickers or marking from indelible ink contain special claims (e.g., quality, nutrient content, health, negative, geographical origin, animal production (e.g., "no antibiotics administered," breed claims, and "no hormones added"), and other claims (e.g., "natural"), guarantees, foreign language or a change of the nutrition facts serving size.

For non-standardized amenable product labeling (e.g., descriptive name products, meat flavors or poultry reaction flavors, etc.) that received sketch approval and the existing labeling is modified by use of pressure sensitive stickers or indelible ink, a sketch approval is required when a change is made to the product label not covered by generic approval regulations 9 CFR 317.5(b) (9) and 381.133(b) (9), e.g., a product name change.

Certain products are not compliant with the generic approval regulations, e.g., exotic animal product labeling, rabbit product labeling, certified pet food labeling, etc. In situations where existing labeling is modified by use of pressure sensitive stickers or indelible ink, the labels must be submitted to the Labeling Consumer Protection Staff in Washington, D.C for sketch approval.

Transferred labels bearing a pressure sensitive sticker covering the existing legend or indelible ink covering the existing legend, are operating under the original establishment's final label approval record, even though the establishment number is for that of the producing establishment. When pressure sensitive stickers are used to cover and correct other existing information or indelible ink is used to cover or add information, the rules for sketch approval and generic labeling apply to the entire label.

This entry cancels Policy Memo 115 dated July 11, 1988, since 115 is out of date.