FDA child resistant packaging

The U.S. Food and Drug Administration (FDA) has specific regulations and guidelines for child-resistant packaging, which are designed to prevent children from accessing potentially harmful substances, particularly medications and household chemicals. These regulations are crucial for ensuring the safety of children, as many common products, like over-the-counter drugs and cleaning products, can be dangerous if ingested.

28mm child resistant cap for liquid

Here are some key points regarding FDA child-resistant packaging:

1. Regulations under the Poison Prevention Packaging Act (PPPA):

The Poison Prevention Packaging Act of 1970 (PPPA) is the main law governing child-resistant packaging. Under the PPPA, the FDA has set standards for packaging to reduce the risk of poisoning in children under five years old. The act requires that most substances be packaged in a way that is difficult for young children to open but can still be opened by adults.

2. Types of Products Subject to Child-Resistant Packaging:

Products covered by PPPA include:

Prescription drugs

Over-the-counter medications (e.g., aspirin, acetaminophen)

Household chemicals (e.g., cleaners, detergents)

Some hazardous substances (e.g., certain pesticides)

Vitamins and iron-containing drugs (especially dangerous for children)

HDPE bottle with child resistant closure

3. Child-Resistant Packaging Standards:

The packaging must meet the following criteria:

Effectiveness Test: Packaging must be designed so that 80% of children under 5 years old cannot open it. However, 90% of adults should be able to open it successfully.

Design: Child-resistant closures can include a variety of mechanisms such as push-and-turn or squeeze-and-turn caps, and blister packs with a special opening method.

Reliability: Packaging must not degrade over time, maintaining its resistance to opening for the product's shelf life.

4. Exemptions and Exceptions:

Not all products are required to be in child-resistant packaging. Some exceptions include:

Certain drugs or chemicals that the FDA has determined do not pose a significant risk to children.

Some low-risk products (such as those with a very low toxicity level).

Also, consumer requests for non-child-resistant packaging are allowed for some prescription medications, but manufacturers must document that the consumer requested it.

5. Enforcement:

The FDA enforces these regulations through regular inspections and reviews. Non-compliance can result in recalls, fines, or other penalties for manufacturers. Products that don't meet child-resistant packaging standards are considered misbranded and can be pulled off the market.

6. Recent Changes or Proposals:

The FDA continually evaluates the effectiveness of these standards. They have sometimes proposed updates or clarifications to improve packaging safety or address new risks, especially with emerging types of products.