CLE Regulatory Submissions & Approvals 3

Question 1

The FDA's Modernization of Cosmetics Regulation Act (MoCRA) affects lactation educators primarily because it includes mandatory registration and listing requirements for:

Accepted Answer

Topical nipple creams and balms marketed as cosmetics

Answer

MoCRA requires facilities that manufacture cosmetic products—including nipple creams and balms—to register with the FDA and list their products.

Question 2

Which regulatory framework governs the operation of nonprofit donor human milk banks in the United States?

Accepted Answer

HMBANA guidelines and applicable state tissue banking laws

Answer

Human Milk Banking Association of North America (HMBANA) guidelines, combined with state tissue banking statutes, form the primary regulatory framework for nonprofit donor milk banks.

Question 3

Under the Affordable Care Act, which provision most directly requires health insurance plans to cover lactation counseling and supplies without cost sharing?

Accepted Answer

Essential Health Benefits (EHB) mandate – preventive services

Answer

The ACA's preventive services mandate (Section 2713) requires non-grandfathered plans to cover USPSTF-recommended preventive services, including breastfeeding counseling, without cost sharing.

Question 4

When a lactation product manufacturer makes a health claim (e.g., 'supports milk production') on packaging, which regulatory standard must that claim meet to avoid FDA enforcement action?

Accepted Answer

Significant scientific agreement (SSA) standard for authorized health claims

Answer

FDA-authorized health claims for food products must meet the significant scientific agreement (SSA) standard, while qualified health claims require a lower level of evidence with a disclaimer.

Question 5

A hospital's lactation program wants to track outcomes across facilities and submit aggregate data to a state health department. Under HIPAA, this activity most likely qualifies as:

Accepted Answer

Public health reporting permitted without individual authorization

Answer

HIPAA's public health exception (45 CFR §164.512(b)) permits disclosure to public health authorities without patient authorization for authorized public health activities.

(CLE) Certified Lactation Educator Practice Test

(CLE) Certified Lactation Educator Practice Test

CLE Regulatory Submissions & Approvals 3