Product Description Regulatory Frameworks & Compliance 3

Question 1

The FTC's 'Made in USA' standard requires that a product be:

Accepted Answer

All or virtually all made in the United States

Answer

The FTC applies an 'all or virtually all' standard, meaning all significant parts and processing must be of US origin to make an unqualified Made in USA claim.

Question 2

Under California's Proposition 65, a product description for a consumer product sold in California must include a warning if the product contains:

Accepted Answer

Chemicals known to the state to cause cancer or reproductive harm above threshold levels

Answer

Prop 65 requires 'clear and reasonable' warnings before exposing consumers to listed chemicals above safe harbor levels.

Question 3

What is the primary purpose of the Fair Packaging and Labeling Act (FPLA) as it relates to product descriptions?

Accepted Answer

To require that consumer commodity labels disclose net quantity, identity of commodity, and name/address of manufacturer

Answer

The FPLA mandates that consumer product labels provide accurate, standardized information about the product's identity, quantity, and manufacturer.

Question 4

A product description states a device is 'FDA cleared.' How does FDA clearance differ from FDA approval?

Accepted Answer

Clearance (510k) means the device is substantially equivalent to a legally marketed device; approval requires proving safety and effectiveness independently

Answer

510(k) clearance is a premarket submission pathway for medical devices deemed substantially equivalent to predicate devices, which is a lower bar than the PMA approval process.

Question 5

Under the Americans with Disabilities Act (ADA), how does compliance apply to online product descriptions for US retailers?

Accepted Answer

Product descriptions and images must be accessible, including alt text for images and accessible formatting

Answer

Courts and the DOJ have increasingly applied ADA requirements to websites, meaning product descriptions, images, and navigation must be accessible to people with disabilities.

Product Description Practice Test

Product Description Practice Test

Product Description Regulatory Frameworks & Compliance 3