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Legal & Regulatory
HerbalGram
The Journal of the American Botanical Council
Legal & Regulatory
Issues
126
page:
35-38

Preserving Peyote Native American Church Leaders Ask that the Sacred Cactus not be Decriminalized

119
page:
56-60

Kratom Crackdown: FDA Intensifies Warnings against the Southeast Asian Tree with Inconclusive Data

118
page:
50-53

AHPA’s Self-Regulatory Initiatives in the US Herb Industry

The American Herbal Products Association adheres to its mission as it pursues responsible commerce in 30 years of self-regulatory efforts
112
page:
60-61

NBTY Signs Agreement with New York Attorney General Regarding DNA Testing of Herbs NY AG finds no evidence for non-compliance with cGMPs

108
page:
68-69
New York Attorney General Targets 13 Manufacturers of Devil’s Claw Supplements Containing Harpagophytum zeyheri
107
page:
61-65
BMPEA/Acacia rigidula Controversy Fuels Further Criticism of Botanicals
104
page:
64-69
Crafting Dietary Supplement Warnings: Recent Developments and Guidelines for Mitigating Risk Associated with Product Liability “Failure to Warn” Claims
103
page:
57-61

Dr. Oz’s “Miracle” Herbal Weight-Loss Products: The Senate Hearing, Advertising Regulations, and Science behind the Claims
101
page:
68-75

New Analyses Fuel Controversy Over ‘Dendrobium Extract’-Containing Sports Supplements: Experts and officials question the legality, source, and safety of what some call the new DMAA
100
page:
86-89

Will ‘Obamacare’ Affect Natural Healthcare in the United States?
99
page:
66-69

Botanical New Drug Applications – The Final Frontier
97
page:
68-69
Update: FDA Approves Crofelemer as First Oral Botanical Drug
93
page:
58-61
Herbal Experts Say CSPI Petition for St. John’s Wort Warning Inaccurate
92
page:
63-64

Health Canada Relaxes Guidelines on p-Synephrine Use

89
page:
55-59

US Dietary Supplement cGMPs and Ingredient Supplier Qualification

88
page:
58-59
Chinese Herbal Medicine Clears US FDA Phase II Trials
86
page:
58-60
European Union Prepares for Full Enforcement of Traditional Herbal Medicine Regulations
85
page:
64-68
The State of Clinical Cannabis Research in the United States
84
page:
66-68
Impact of Current Good Manufacturing Practices for Dietary Supplements on Small Manufacturers
page:
69
AHPA and CRN Comment on FDA’s Proposed Policy on Economically Motivated Adulteration
83
page:
62
GAO Calls for More Dietary Supplement Regulation
81
page:
67-69
FDA Accepts Safety of Two Stevia Preparations for Food and Beverage Use
80
page:
68-69
CRN-NAD Program Increasing Reviews of Dietary Supplement Advertising
page:
70-71
Native Essence Herb Company Sues FTC Over “Traditional Use” Claims
79
page:
68
New Farm Bill Includes Provisions on Raw Ginseng Labeling and Eligibility of Herbal Crops under Grant Program
page:
66-67
GlaxoSmithKline Petitions FDA to Disallow Weight Loss Claims for Dietary Supplements
78
page:
58-59
Trade Associations Request Withdrawal of FDA
77
page:
54-55
Trade Organizations Submit Comments on FDA's GMP Interim Final Rule
76
page:
58
Review of FDA’s Final GMPs for Dietary Supplements
75
page:
64
FDA Creates New Agency Position for Food Safety and Defense
page:
62-63
Supreme Court Denies Appeal of Ephedra Ban
74
page:
62-63
FDA Approves Special Green Tea Extract as a New Topical Drug for Genital Warts Expert Says Development Marks the Birth of a "New Industry"
73
page:
62
Canada's NHPD Inducts New Expert Members
page:
60-61
President Signs New Law to Require Reporting of Serious Adverse Events of Dietary Supplements and OTC Drugs
page:
64
European Legislation on Food Supplement Claims and Fortification Becomes Effective in 2007
72
page:
55
Appeals Court Sides with FDA in Ephedra Ban Case
page:
56-58
European Health Agencies Recommend Liver Warnings on Black Cohosh Products
page:
57
Health Canada Issues Advisory on Black Cohosh
page:
59
UK Expert Committee Upholds Kava Ban
page:
60-61
FDA Rejects Proposed Health Claim for Cardiovascular Benefits of Green Tea
page:
61-62
AHPA Issues Trade Recommendations for Hoodia gordonii, Ginkgo, Pregnancy Labeling, and Internet Sales
page:
64-65
FDA Denies Medicinal Value of Smoked Marijuana
71
page:
58-59
WHO Surveys Worldwide Patterns of Herbal Regulations
page:
60-61
Australian TGA Publishes Liver Warning Policy for Black Cohosh
page:
62-63
Supreme Court Ruling Protects Religious Group's Access to Ayahuasca
70
page:
62-66
Proposed Quality Control Guidelines for the EU Directive on Traditional Herbal Medicinal Products: Implications for Small- to Medium-Sized Enterprises
69
page:
56-58
AHPA Adopts New and Revised Trade Recommendations for Herb Industry Self-Regulation
page:
60-61
Herb Industry Self-Regulation Initiative on Common Names for Herbal Ingredients Becomes Federal Law in January
68
page:
60-62
Rooibos Tea Trademark Dispute Settled
67
page:
64-67
Ban of Dietary Supplements Containing Low Doses of Ephedrine Alkaloids Overturned by District Court
66
page:
62
ABC Files Public Comments to FDA on New Dietary Ingredients
65
page:
58-59
President Signs New Law Banning Designer Steroids Dietary Supplements: DHEA Exempted from Ban
64
page:
52-53
FDA Issues Final Guidance for Industry Regarding Botanical Drug Products
page:
54-55
MHRA Publishes Guidance on Acceptable Sources of Evidence for Traditional Use Under the Future EU Directive on Traditional Herbal Medicinal Products
63
page:
64-69
A Review of the European Food Supplements and Traditional Herbal Medicines Directives
page:
70-74
New Dietary Ingredients: DSHEA Provides Protection from Potentially Unsafe New Ingredients with no Prior Market History in the U.S.
62
page:
63-64
FDA Issues Final Rule Banning Ephedra
page:
65
FTC Issues Reports on Deceptive Weight Loss Advertising
page:
66-67
British Government Calls for Regulation of Herbal and Acupuncture Practitioners in UK
61
page:
64-55
FDA Announces Ban on Ephedra Supplements: Federal Move Follows Bans by California, Illinois and New York
page:
56-59
Congress Increasingly Active on Herbs and Dietary Supplements: Durbin's Bill Intends to Clamp Down on Supplement Safety while Hatch and Harkin Propose More Funding for FDA Enforcement of DSHEA
page:
60-61
Supreme Court Refuses Government Appeal on Medical Marijuana Advice by Doctors
page:
62-63
Bioterrorism Act: Administrative Detention, Recordkeeping Requirements
page:
64
Doctor of Naturopathy Licensure Law Passes in California
60
page:
62-65
Canada Issues Final Natural Health Product Regulations
page:
65
American Botanical Council Clarifies Safety Issue on Star Anise Tea
page:
66
FDA Publishes Rule to Incorporate AHPA's Herbs of Commerce in Herb Labeling
59
page:
50-56
The Slow Demise of FDA Censorship
page:
52-53
AHPA's Input on Saw Palmetto Health Claims Filed in Court
page:
57-58
Industry Increasingly Nervous about Drug Orientation of FDA's Proposed GMPs for Dietary Supplements: High Costs Threaten Smaller Companies
58
page:
65-67
The Bioterrorism Act: Overview and Implications for Industry
page:
62-65
FDA Issues Proposed GMPs for Dietary Supplements
page:
68-70
FDA Proposes Strong Warnings for Ephedra, Releases Independent RAND Report on Ephedra Safety and Efficacy
56
page:
54
Farm Bill Bans Use of Name
page:
56
FDA Issues Final Rule Banning Use of Aloe and Cascara Sagrada in OTC Drug Products
page:
59
FTC Commissioner Wants More Rigorous Self-Regulation in Dietary Supplement Industry
55
page:
56
Herbal Dietary Supplements and Foods: Product Liability Analysis for a "Failure to Warn" of Herb/Drug Interactions and Guidelines to Develop Appropriate Warnings
54
page:
62

Trade Organizations, Court and Government Actions Affect Herbal Industry

53
page:
60
HHS Report Calls for Increased Monitoring of Adverse Events
page:
60
New Office of Food Additive Safety at FDA
page:
61
FDA Sends Warning Letters to Functional Food Makers
page:
61
Cholestin® Reformulated in Response to U.S. Court Decision
page:
62
FDA and FTC Act on Comfrey
page:
62
FTC Cracking Down on Internet Claims
52
page:
55
House Committee on Government Reform Holds Hearings on Dietary Supplements
page:
56
New FDA Advisory and AHPA Trade Recommendation on Aristolochia
50
page:
66
CSPI Files Complaint to FDA on Herbs in Foods
page:
64
Ephedra Update: Industry Coalition Asks FDA to Adopt National Labeling Guidelines on Ephedra; Offers Cooperative Research with NIH
page:
68
FDA Publishes New Draft Guidance for Botanical Drug Products
49
page:
64
Regulation in the Herb Market: The Myth of the "Unregulated Industry"
48
page:
32-38
FDA Issues Final Rules for Structure/Function Claims for Dietary Supplements Under DSHEA.
page:
40
FDA Issues Proposed Regulations on Foreign Marketing Data for OTC Drug Approvals.
page:
42
Self Regulatory Initiatives by the Herbal Industry.
47
page:
34
GAO Criticizes FDA's Proposed Regulations on Ephedrine-containing Dietary Supplements: Report Notes Lack of Science in FDA Process.
page:
38-39
DSHEA at Five Years: A Review of Structure-Function Claims.
page:
40-45
Monograph Update: WHO Publishes Herbal Monographs; ABC, AHP, ESCOP and USP Continue Monograph Publication.
46
page:
26
Federal Court Upholds Dietary Supplement Status of Cholestin.
page:
27
Commentary on House Hearings on DSHEA and Supplements.
45
page:
29
Forget About Disease: Botanical Claims Under the DSHEA Paradigm.
page:
34
FTC Publishes Dietary Supplement Advertising Guide.
44
page:
24
The Health of the Canadian Herbal Medicinal Market: An Editorial.
page:
28
Operator of Lab Sent to Prison for "fx" Mislabeling.
43
page:
NAN
USP Publishes Information Monographs on Ginger and Valerian: Pharmaceutical body claims "lack of adequate evidence and conflicting study results".
page:
26
FDA Proposes New Rules on Dietary Supplement Structure-Function Claims: Agency redefines "Disease" in what critics call an attempt to limit claims and weaken DSHEA.
page:
29
Federal Court Lifts FDA Import Ban on Cholestin.
42
page:
22
Canadian Regulatory Update.
page:
23
Phytotherapy Aids in Benzodiazepine Withdrawal.
page:
25
AHPA's Recommended Label Language for Kava Products.
41
page:
24
President's Commission on Dietary Supplement Labels Issues Final Report: Botanicals Are a Key Issue.
page:
27
"When Will There Come a Savior?"
page:
28
FDA Proposes Health Claim for Psyllium.
page:
29
German Government Limits Ginkgolic Acid Levels.
40
page:
26
FDA Proposes Warnings and Dose Limits on Ephedra: Government Proposal Comes Three Years After Industry Warning.
page:
27
LAPD Issues Kava Retraction.
page:
28
Industry Alert: Plantain Adulterated with Digitalis.
39
page:
25
Ma Huang Update: Ohio Amends Ephedrine Ban; Herb Products Allowed with Limited Alkaloid Levels.
page:
25
Texas Pulls Back Proposed Regulations Banning Ephedra.
page:
26
California Requires Warning Labels for Products Containing Stimulant Laxative Herbs: GNC Requiring Laxative Warning Labels in all Stores.
page:
28
Report on the Conference of the Codex Alimentarius: Regulators Meet to Establish International Standards for Foods.
page:
29
Overview of Codex Procedures.
38
page:
25
FDA Has Adequate Power And Authority To Protect The Public From Unsafe Dietary Supplements.
page:
27
FDA Accepts Supplement Industry GMP Proposal: New Good Manufacturing Practices Required Under DSHEA To Be Published For Public Comment.
page:
28
FDA Hearing Portends Uncertain Future For Mahuang: Members of FDA Panel Divided on Fate of Controversial Herb.
page:
31
Nebraska Law Criminalizes Ma Huang.
37
page:
20
The Agony of the Ecstasy: Herbal High Products Get Media Attention.
page:
21
FDA Statement on Street Drugs Containing Botanical Ephedra.
36
page:
21
FDA Holds Expert Advisory Committee Hearing on Ma Huang: Experts Recommend Appropriate Labeling and Warnings - Not Banning the Herb.
35
page:
17
FDA Lifts Import Alert On Stevia: Herb Can Be Imported Only As Dietary Supplement; Future Use As A Sweetener Is Still Unclear.
page:
19
EAPC Files Petitions For OTC Drug Use For Valerian And Ginger.
page:
21
Ma Huang Update: Industry Group Submits Ma Huang Safety Data To Texas Department of Health.
page:
23
AHPA Rescinds Chaparral Ban: Creates Hotline For Adverse Effects.
34
page:
18
FDA DROPS IMPORT ALERT ON EVENING PRIMROSE OIL.
page:
19
FDA APPROVES TAXOL BUT NOT TAXOTERE.
page:
21
CANADA APPROVES GINKGO FOR FOOD USE.
33
page:
20
ABC and HRF Publications Cited in Senate Report on Dietary Supplement Act: Respected medical and scientific authorities recognize the important role of herbs as dietary adjuncts and advocate their proper use.
page:
22
AHPA Issues Chinese Patent Medicine Policy.
page:
23
FDA and the Herbal Industry: Problems, Antagonisms and a Possible Solution.
32
page:
18
Congress Passes Dietary Supplement Health And Education Act of 1994: Herbs To Be Protected As Supplements.
page:
20
Harmonizing North American Herbal Regulation: A U.S. Perspective.
page:
23
Canadian Expert Advisory Committee On Herbs And Botanical Preparations Second Report: Can the U.S. Learn from the Canadian Regulatory Model?
29
page:
37
HERB INDUSTRY LAUNCHES MAJOR SCIENTIFIC PROGRAM: HRF PROJECT TO DOCUMENT SAFETY AND BENEFITS OF HERBS.
page:
38-39
Firm Wins Appeal in Black Currant Oil Case: Court Chides FDA's "Alice-in-Wonderland" Approach.
28
page:
36
European/American Phytomedicines Group Moves to Expand FDA OTC Drug Policy.
page:
37
NLEA and Hatch Bill Update: Widespread Support Prompts NLEA Moratorium.
27
page:
18-19
U.S. Herb Industry Proposes Self Regulation.
page:
24-26
Health Freedom Bill Would Protect Herbs.
26
page:
22
AHPA Petitions FDA for Approval of Stevia Leaf Sweetener.
page:
23
NLEA UPDATE.
24
page:
23
LEGAL AND REGULATORY: FDA Moves on OTC Diet Drug Ingredients; Warnings for Guar Gum.
23
page:
32
FDA Declares 258 OTC Ingredients Ineffective: Many Herbs Included; Prunes are not an effective laxative, says FDA panel!
page:
35
FDA Reclassifies OTC Prostate Products to Rx Status.
page:
36
FDA Collecting Information on Herb Products to Assess Safety: Comfrey Main Item for Review.
22
page:
18
LEGAL AND REGULATORY: CANADIAN UPDATE; "Traditional Herbal Medicines" in Current Drug Category.