H.R. 7050: Homeopathic Drug Product Safety, Quality, and Transparency Act

The Homeopathic Drug Product Safety, Quality, and Transparency Act is designed to amend current legislation related to homeopathic drug products under the Federal Food, Drug, and Cosmetic Act. The aim of the bill is to establish clear safety, quality, and transparency standards that homeopathic products must meet. Here are the key provisions of the bill:

Purpose

The bill emphasizes the importance of homeopathic medicines for consumers and seeks to create a regulatory pathway that allows the continued access to safe homeopathic drug products. It aims to ensure that while the federal government protects against harmful products, it does not create unnecessary barriers that would limit access to safe homeopathic remedies.

Definitions

• Homeopathic Drug Product: A drug that contains one or more homeopathic ingredients and no other active ingredients.
• Homeopathic Ingredient: An ingredient that is listed in the Homeopathic Pharmacopoeia of the United States or is prepared according to set standards for homeopathy.

Safety, Quality, and Transparency Requirements

The bill outlines specific provisions for homeopathic drug products:

• Current regulations outside this section will not apply unless they align with the new homeopathic standards.
• Homeopathic products must not be adulterated, which means they must meet the established safety and quality standards.
• Manufacturers can petition for exemptions or alternative standards, but any changes must ensure product safety.
• Testing requirements are specified, including the need for testing to ensure the absence of harmful contaminants.

Labeling and Misbranding

The bill provides detailed requirements for labeling homeopathic drug products:

• The word "homeopathic" cannot be included unless the product meets the definitions stipulated by the new regulations.
• Labeling must include the purpose or indications for use based on recognized sources.
• Products need to clearly state that their uses have not been evaluated by the FDA.

Exemption from Premarket Approval

The bill states that homeopathic drug products do not require premarket approval, easing the pathway to market for these products.

Homeopathic Drug Product Advisory Committee

The legislation proposes the establishment of a committee to advise on the regulation of homeopathic drug products. This committee will include various representatives from consumer and practitioner backgrounds, aiming to offer a balanced perspective. The committee will meet regularly to discuss homeopathy-related issues and can also investigate adverse events related to homeopathic products.

Non-Preemption of State Laws

The bill clarifies that it does not interfere with state laws regarding the practice of homeopathy, thus maintaining state authority in this area.

Other Provisions

The bill aims to withdraw previous guidance concerning homeopathic drug products that may be inconsistent with the new regulations. It also includes language regarding the burden of proof in legal contexts related to violations of these provisions.

Relevant Companies

• UNFI (United Natural Foods, Inc.): As a distributor of natural and organic foods, including homeopathic products, UNFI may face shifts in the market and regulatory requirements regarding the distribution and labeling of homeopathic remedies.
• TARO (Taro Pharmaceutical Industries Ltd): As a manufacturer of topical medications, Taro may see changes in the production and regulation of its homeopathic offerings.