Food and beverage companies may be surprised to learn that the U.S. Food and Drug Administration (“FDA”) is not the exclusive regulatory authority over the safety of foods and beverages. Indeed, other governmental authorities may govern depending on the nature of the product. For example, the U.S. Department of Agriculture is the principal regulator of meat, poultry, and some fish and egg products.[1]
Another important agency, the Consumer Product Safety Commission (“CPSC”) is an independent federal agency that does not regulate the safety of food and beverages, but has regulatory authority over food packaging or containers that present mechanical or physical risks of injuries not related to food contamination, migration, or spoilage, such as sharp edges, flammability, etc. And the CPSC is becoming increasingly aggressive in enforcing consumer product safety regulations and standards. The following are six points food and beverage companies should know about CPSC compliance:
- Under the Poison Prevention Packaging Act (PPPA) (15 U.S.C. §§ 1471-1477) as enforced by the CPSC, household substances, including food and dietary supplements that include certain chemicals, such as fluoride and iron, must have child-resistant packaging.[2]
- Under the Consumer Product Safety Act (CPSA) (15 U.S.C. §§ 2051 et seq.) as enforced by the CPSC, manufacturers, importers, distributors, and retailers of food and beverage products must consider whether food and beverage packaging could pose a safety hazard, for example, because of sharp edges.[3]
- Under the CPSA as enforced by the CPSC, food and beverage companies should consider whether food and beverage packaging could pose a choking hazard. For example, recently the CPSC issued a recall for a liquid rolling candy product because the rolling ball in the candy packaging could dislodge and create a choking risk to children.[4]
- The CPSC is laser-focused on children’s products, including requiring manufacturers and importers of products marketed towards children twelve years old and younger to certify in a written Children’s Product Certificate that their children’s products comply with applicable children’s product safety rules based on test results from a CPSC-accepted laboratory. [5] This includes children’s feeding products like cups, plates, and baby bottles.
- Under the CPSA, manufacturers, importers, and distributors of food and beverage products should consider how potential mechanical hazards could affect their food and beverage products. For example, the CPSC issued a recall for instant ramen noodle products where the packaging could pose a fire risk when heated in a microwave.[6] Additionally, the CPSC issued a recall for countertop ice makers due to laceration hazards.[7]
- Manufacturers, importers, distributors, and retailers must timely report to the CPSC known product defects and other noncompliance with the PPPA and CPSA, or risk steep civil penalties of up to $120,000 per knowing violation and $17,150,000 for a series of related violations, as adjusted for inflation in 2021[8]. And, the CPSC is working with Congress to remove penalty caps entirely, adding another layer of exposure to companies under its jurisdiction.[9]
Foley’s multi-disciplinary and multi-jurisdictional team is prepared to help clients accomplish their legal and business strategies with respect to FDA and CPSC compliance. To discuss how FDA and CPSC regulatory requirements may impact your business, contact Erik Swanholt ([email protected]), Nathan A. Beaver ([email protected]), Kristin McGaver Sikora ([email protected]), or Megan Chester ([email protected]).
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[1] USDA Markets, Regulation, and Policy Statement (updated Feb. 29, 2024) https://www.ers.usda.gov/topics/food-safety/markets-regulation-and-policy/#:~:text=USDA%20is%20responsible%20for%20regulating,and%20almost%20all%20other%20foods.
[2] See 15 U.S.C. § 1472; 16 C.F.R. § 1700.14.
[3] Memorandum of Understanding Between the U.S. Consumer Product Safety Commission and The U.S. Food and Drug Administration, MOU 225-76-2003 (Dec. 15, 2017) (available at: https://www.fda.gov/about-fda/domestic-mous/mou-225-76-2003).
[4] See https://www.cpsc.gov/Recalls/2024/Twenty-Four-Six-Foods-Recalls-Happiness-USA-Roller-Ball-Candy-Due-to-Choking-Hazards.
[5] 15 U.S.C. § 1278a.
[6] See https://www.cpsc.gov/Recalls/2019/Lotus-Foods-Recalls-Ramen-Noodle-Soup-Cups-Due-to-Fire-and-Burn-Hazards.
[7] See https://www.cpsc.gov/Recalls/2024/Countertop-Nugget-Ice-Makers-Recalled-Due-to-Laceration-Hazard-Sold-Exclusively-through-Amazon-Distributed-by-Far-Success-Trading.
[8] Civil Penalties, Notice of Adjusted Maximum Amounts, 86 F.R. 68244 (Dec. 1, 2021), https://www.govinfo.gov/content/pkg/FR-2021-12-01/pdf/2021-26082.pdf.
[9] https://www.foley.com/insights/publications/2024/02/consumer-advocacy-protection-remove-cap-civil-penalties/.
