Lobbying Disclosure Act of 1995 (Section 5) - All Filers Are Required to Complete This Page

9. Check if this filing amends a previously filed version of this report

LOBBYING ACTIVITY. Select as many codes as necessary to reflect the general issue areas in which the registrant engaged in lobbying on behalf of the client during the reporting period. Using a separate page for each code, provide information as requested. Add additional page(s) as needed.

15. General issue area code PHA

16. Specific lobbying issues

Pseudoephedrine -- Potential legislation to implement real-time, stop-sale electronic tracking system for sales of medications containing pseudoephedrine in order to preserve consumer access to the ingredient and oppose PSE restrictions such as a prescription requirement (no bill number).

Mandatory recall authority of the FDA

Supporting a process within FDA that ensures clarity and timely outcomes for the FDA, applicants and stakeholders, as well as utilizing existing technologies to further streamline the prescription-to-nonprescription switch application process without changing the existing clear distinction between prescription and nonprescription medicines.

H.R.3164 - Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2020

S.930 - Allowing Greater Access to Safe and Effective Contraception Act

S.1847/H.R. 3296 - Affordability is Access Act

S.2522 - Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2020

H.R.6058 - SHOP SAFE Act of 2020

S.3431 - INFORM Consumers Act

Legislation to increase domestic production of pharmaceuticals and the domestic supply chain.

H.R. 6395 - National Defense Authorization Act for Fiscal Year 2021
S.4049 - National Defense Authorization Act for Fiscal Year 2021

HR 8179 - Hemp and Hemp-Derived CBD Consumer Protection and Market Stabilization Act of 2020

17. House(s) of Congress and Federal agencies Check if None

U.S. SENATE, U.S. HOUSE OF REPRESENTATIVES, Food & Drug Administration (FDA), Vice President of the U.S.

18. Name of each individual who acted as a lobbyist in this issue area

19. Interest of each foreign entity in the specific issues listed on line 16 above Check if None

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LOBBYING ACTIVITY. Select as many codes as necessary to reflect the general issue areas in which the registrant engaged in lobbying on behalf of the client during the reporting period. Using a separate page for each code, provide information as requested. Add additional page(s) as needed.

15. General issue area code ALC

16. Specific lobbying issues

H.R.863 - DXM Abuse Prevention Act of 2019 - legislation that would ban the sale of over-the-counter cough and cold medications containing the active ingredient dextromethorphan (DXM) to minors under the age of 18. Additionally, would ban the sale of bulk, unfinished DXM to entities not registered with the U.S. Food and Drug Administration; all sections.

H.R.2020/S.989 - STEER Act -- Tableting and Encapsulating Machine Regulation Gives the Drug Enforcement Agency additional authority to regulate tableting and encapsulating manufacturing machines.

FDA Packaging and Disposal, no bill number. Directs FDA to work with manufacturers to establish programs for efficient return or destruction of unused Schedule II drugs, with an emphasis on opioids. These methods could include mail-back pouches to secure facilities for incineration, or methods to immediately inactivate/render unattractive unused drugs.

H.R.3055 - Commerce, Justice, Science, Agriculture, Rural Development, Food and Drug Administration, Interior, Environment, Military Construction, Veterans Affairs, Transportation, and Housing and Urban Development Appropriations Act, 2020

H.R.3171 - Safe Disposal of Opioids Act of 2019

S.2584 - Commerce, Justice, Science, and Related Agencies Appropriations Act, 2020

S.2102 - Turn the Tide Act

H.R.4510 - Criminalizing Abused Substance Templates Act of 2019

H.R.1865 - Further Consolidated Appropriations Act, 2020

17. House(s) of Congress and Federal agencies Check if None

U.S. SENATE, U.S. HOUSE OF REPRESENTATIVES, Food & Drug Administration (FDA)

18. Name of each individual who acted as a lobbyist in this issue area

19. Interest of each foreign entity in the specific issues listed on line 16 above Check if None

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LOBBYING ACTIVITY. Select as many codes as necessary to reflect the general issue areas in which the registrant engaged in lobbying on behalf of the client during the reporting period. Using a separate page for each code, provide information as requested. Add additional page(s) as needed.

15. General issue area code TAX

16. Specific lobbying issues

S.12 - Health Savings Act of 2019 - Makes changes to Health Savings Accounts and Flexible Spending Accounts to include eligibility for OTC medicines and dietary supplements.

H.R. 1922/S.1089 - The Restoring Access to Medication Act -- To amend the Internal Revenue Code of 1986 to include certain over-the-counter medical products as qualified medical expenses.

S.3129 - Lower Costs, More Cures Act of 2019

S.3112 - Personalized Care Act of 2019

H.R.748 - CARES Act

Legislation to expand access to dietary supplements via HSA/FSA eligibility

H.R.7242 - To amend the Internal Revenue Code of 1986 to permit expenditures from health savings accounts for gym memberships and costs of home gym equipment, to repeal the requirement that health plan be high deductible, and for other purposes.

S.4463 - A bill to amend the Internal Revenue Code of 1986 to include certain over-the-counter dietary supplement products as qualified medical expenses

17. House(s) of Congress and Federal agencies Check if None

U.S. SENATE, U.S. HOUSE OF REPRESENTATIVES, Treasury - Dept of

18. Name of each individual who acted as a lobbyist in this issue area

19. Interest of each foreign entity in the specific issues listed on line 16 above Check if None

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LOBBYING ACTIVITY. Select as many codes as necessary to reflect the general issue areas in which the registrant engaged in lobbying on behalf of the client during the reporting period. Using a separate page for each code, provide information as requested. Add additional page(s) as needed.

15. General issue area code FOO

16. Specific lobbying issues

Food and Drug Administration (FDA) draft "Guidance for Industry: New Dietary Ingredient Notifications and Related Issues."

Supports efforts to encourage FDA to develop a legal path for CBD as a new dietary ingredient. (no bill number)

H.R.3055 - Commerce, Justice, Science, Agriculture, Rural Development, Food and Drug Administration, Interior, Environment, Military Construction, Veterans Affairs, Transportation, and Housing and Urban Development Appropriations Act, 2020

S.1215 - National Defense Authorization Act for Fiscal Year 2020

S.2032 - A bill to expand research on the cannabidiol and marihuana.

S.1717/H.R. 3142 - SNAP Vitamin and Mineral Improvement Act of 2019

H.R.1887 - National Institute of Nutrition Act

H.R.1595 - Secure And Fair Enforcement Banking Act of 2019

S.2895 - SARMs Control Act of 2019

S.1790 - National Defense Authorization Act for Fiscal Year 2020

H.R.1865 - Further Consolidated Appropriations Act, 2020

H.R.5587 - To amend the Federal Food, Drug, and Cosmetic Act with respect to the regulation of hemp-derived cannabidiol and hemp-derived cannabidiol containing substances.

17. House(s) of Congress and Federal agencies Check if None

U.S. SENATE, U.S. HOUSE OF REPRESENTATIVES, Food & Drug Administration (FDA)

18. Name of each individual who acted as a lobbyist in this issue area

19. Interest of each foreign entity in the specific issues listed on line 16 above Check if None

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LOBBYING ACTIVITY. Select as many codes as necessary to reflect the general issue areas in which the registrant engaged in lobbying on behalf of the client during the reporting period. Using a separate page for each code, provide information as requested. Add additional page(s) as needed.

15. General issue area code MAN

16. Specific lobbying issues

H.R.269 - Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019 -- To reauthorize certain programs under the Public Health Service Act and the Federal Food, Drug, and Cosmetic Act with respect to public health security and all-hazards preparedness and response, to clarify the regulatory framework with respect to certain nonprescription drugs that are marketed without an approved drug application, and for other purposes.

H.R.648 - Consolidated Appropriations Act, 2019 -- Making appropriations for the fiscal year ending September 30, 2019, and for other purposes. Includes language authorizing the collection of Monograph Reform user fees.

H.J.Res.28 - Further Additional Continuing Appropriations Act, 2019 - This joint resolution provides continuing FY2019 appropriations to several federal agencies through the earlier of February 15, 2019, or the enactment of the applicable appropriations legislation.

H.J.Res.31 - Consolidated Appropriations Act, 2019 -- This joint resolution provides continuing FY2019 appropriations for the Department of Homeland Security (DHS) through the earlier of February 15, 2019, or the enactment of the applicable appropriations legislation. It is known as a continuing resolution (CR) and ends the partial DHS shutdown that began on December 22, 2018, because the existing CR expired and the FY2019 DHS appropriations bill has not been enacted.

H.R.268 - Supplemental Appropriations Act, 2019 -- This bill provides $12.1 billion in FY2019 supplemental appropriations to several federal departments and agencies for expenses related to the consequences of recent wildfires, hurricanes, volcanos, earthquakes, typhoons, and other natural disasters.

S.726 - Personal Care Products Safety Act -- To amend the Federal Food, Drug, and Cosmetic Act to ensure the safety of cosmetics.

Cosmetic Safety Enhancement Act of 2019 (Pallone/Shimkus discussion draft) -- To amend the Federal Food, Drug, and Cosmetic Act to improve cosmetic safety, and for other purposes

H.R.3443 - Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2019

S.1895 - Lower Health Care Costs Act

S.2522 - Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2020

H.R.4296 - Safe Cosmetics and Personal Care Products Act of 2019

Udall/Lowenthal consumer products plastics outline, proposal to address consumer plastics issues. No bill number.

H.R.2296/S.1391 - More Efficient Tools to Realize Information for Consumers Act

S.2740 - Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2019

H.R.1865 - Further Consolidated Appropriations Act, 2020

H.R.5279 - Cosmetic Safety Enhancement Act of 2019

21st Century Cures Act 2.0 (No bill number)

H.R.2064 - To amend title XI of the Social Security Act to require manufacturers of certain drugs, devices, biologicals, and medical supplies to report on product samples provided to certain health care providers, and for other purposes.

S.1391 - Fair Accountability and Innovative Research Drug Pricing Act of 2019

H.R.748 - CARES Act

Critical infrastructure and supply chain

HR 8837 -- Continuing Appropriations Act, 2021 and Other Extensions Act

17. House(s) of Congress and Federal agencies Check if None

U.S. SENATE, U.S. HOUSE OF REPRESENTATIVES, Food & Drug Administration (FDA), Homeland Security - Dept of (DHS)

18. Name of each individual who acted as a lobbyist in this issue area

19. Interest of each foreign entity in the specific issues listed on line 16 above Check if None

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LOBBYING ACTIVITY. Select as many codes as necessary to reflect the general issue areas in which the registrant engaged in lobbying on behalf of the client during the reporting period. Using a separate page for each code, provide information as requested. Add additional page(s) as needed.

15. General issue area code ENV

16. Specific lobbying issues

H.R.1834 - To direct the Secretary of Commerce to issue regulations prohibiting the use of sunscreen containing oxybenzone or octinoxate in a National Marine Sanctuary in which coral is present, and for other purposes.

S.1371/H.R. 2588 - Oxybenzone and Octinoxate Impact Study Act of 2019

H.R.2587/S. 1375 - Reef Safe Act of 2019

S.3263/H.R.5845 - Break Free From Plastic Pollution Act of 2020

17. House(s) of Congress and Federal agencies Check if None

U.S. SENATE, U.S. HOUSE OF REPRESENTATIVES, Commerce - Dept of (DOC)

18. Name of each individual who acted as a lobbyist in this issue area

19. Interest of each foreign entity in the specific issues listed on line 16 above Check if None

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Information Update Page - Complete ONLY where registration information has changed.

20. Client new address

21. Client new principal place of business (if different than line 20)

22. New General description of client’s business or activities

LOBBYIST UPDATE

23. Name of each previously reported individual who is no longer expected to act as a lobbyist for the client

ISSUE UPDATE

24. General lobbying issue that no longer pertains

AFFILIATED ORGANIZATIONS

25. Add the following affiliated organization(s)

Internet Address:

26. Name of each previously reported organization that is no longer affiliated with the registrant or client

FOREIGN ENTITIES

27. Add the following foreign entities:

28. Name of each previously reported foreign entity that no longer owns, or controls, or is affiliated with the registrant, client or affiliated organization

CONVICTIONS DISCLOSURE

29. Have any of the lobbyists listed on this report been convicted in a Federal or State Court of an offense involving bribery, extortion, embezzlement, an illegal kickback, tax evasion, fraud, a conflict of interest, making a false statement, perjury, or money laundering?
No Yes