Product Description Regulatory Frameworks & Compliance 3 — Questions and Answers
Question 1: The FTC's 'Made in USA' standard requires that a product be:
- All or virtually all made in the United States (Correct answer)
- Assembled in the US regardless of component origin
- At least 51% manufactured domestically
- Designed and engineered in the US
Correct answer: All or virtually all made in the United States
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:
- Chemicals known to the state to cause cancer or reproductive harm above threshold levels (Correct answer)
- Any synthetic ingredients regardless of quantity
- More than 10 ingredients not listed on the FDA GRAS list
- Artificial colors approved by the FDA
Correct answer: Chemicals known to the state to cause cancer or reproductive harm above threshold levels
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?
- To require that consumer commodity labels disclose net quantity, identity of commodity, and name/address of manufacturer (Correct answer)
- To regulate the use of color claims in advertising
- To establish maximum price points for consumer goods
- To prohibit comparative advertising
Correct answer: To require that consumer commodity labels disclose net quantity, identity of commodity, and name/address of manufacturer
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?
- Clearance (510k) means the device is substantially equivalent to a legally marketed device; approval requires proving safety and effectiveness independently (Correct answer)
- Clearance applies to drugs, approval applies to devices
- They are interchangeable terms with no regulatory distinction
- Clearance requires clinical trials; approval does not
Correct answer: Clearance (510k) means the device is substantially equivalent to a legally marketed device; approval requires proving safety and effectiveness independently
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?
- Product descriptions and images must be accessible, including alt text for images and accessible formatting (Correct answer)
- Only physical store signage must be ADA compliant
- Online accessibility is voluntary and not legally enforceable
- Only checkout processes must meet accessibility standards
Correct answer: Product descriptions and images must be accessible, including alt text for images and accessible formatting
Courts and the DOJ have increasingly applied ADA requirements to websites, meaning product descriptions, images, and navigation must be accessible to people with disabilities.
Question 6: Which agency enforces truth-in-advertising rules for most product descriptions in the United States?
- Federal Trade Commission (FTC) (Correct answer)
- Food and Drug Administration (FDA)
- Consumer Financial Protection Bureau (CFPB)
- Securities and Exchange Commission (SEC)
Correct answer: Federal Trade Commission (FTC)
The FTC is the primary federal agency responsible for preventing deceptive and unfair business practices, including false or misleading product advertising.
Question 7: A seller includes testimonials in a product description claiming users lost 30 pounds in 30 days. The FTC requires that such testimonials:
- Reflect the typical consumer experience or clearly disclose that results are not typical (Correct answer)
- Only appear if the seller has scientific studies supporting the claim
- Be accompanied by a government seal of approval
- Be limited to endorsements from medical professionals
Correct answer: Reflect the typical consumer experience or clearly disclose that results are not typical
FTC guidelines require that testimonials reflect what consumers generally achieve, or include a clear disclosure of typical results if the testimonial is atypical.
Product Description Regulatory Frameworks & Compliance 3
The FTC's 'Made in USA' standard requires that a product be: