Source: http://naturepaq.net/FDA-Dietary-Supplements-Regulation.html
Timestamp: 2019-08-19 00:09:57
Document Index: 330884845

Matched Legal Cases: ['§1', '§2', '§9', '§342', '§342', '§111', '§7']

Department of Healtrh & Human Services - Office of Dietary Supplements guidelines
Complete Organic Vitamins Minerals 100% Natural Fountain of Youth Nutrition Grower direct fresh
Siam Industries International Co. Ltd., a US/Thailand Limited Amity Company is dedicated to manufacturing and importing superior grade organic Dietary Health Supplements from Thailand that adhere to both the laws setforth by the Thai Ministry of Public Health/FDA guidelines as well as the US Department of Health & Human Services - Dietary Supplement Health and Education Act of 1994
Dietary Health Supplement guidelines.
Dietary Health Supplements in the United States were originally regulated under the Federal Food, Drug, and Cosmetics Act. The United States Federal Food, Drug, and Cosmetic Act (abbreviated as FFDCA, FDCA, or FD&C), is a set of laws passed by Congress in 1938 giving authority to the U.S. Food and Drug Administration (FDA) to oversee the safety of food, drugs, medical devices, and cosmetics.
The Dietary Supplement Health and Education Act of 1994 - Public Law 103-417 - 103rd Congress supercedes and/or amends the original legislation setforth in the Federal Food, Drug, and Cosmetic Act of 1938.
Objective; To amend the Federal Food, Drug, and Cosmetic Act to establish standards with respect to dietary supplements, and for other purposes. Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled,
§1. Short Title; Reference; Table Of Contents. (a) Short Title. - This Act may be cited as the “Dietary Supplement Health and Education Act of 1994”.
§2. Findings. US 103rd Congress Public Law 103-417 finds that;
(B) the industry consistently projects a positive trade balance; and (C) the estimated 600 dietary supplement manufacturers in the United States produce approximately 4,000 products, with total annual sales of such products alone reaching at least $4,000,000,000;
Read the complete overview from the US Department Of Health & Human Services,
I. We fully support legal, safe & effective bacteria-free GMP manufactured Dietary Health Supplements & profoundly object to the on-going illegal activity being perpetrated by hi-tech internet portals who circumvent the laws of Thailand and America by electronically mass marketing undocumented, unlicensed, black-market and/or adulterated supplements currently being imported into the United States through the US Postal system hence avoiding the import-export laws and health & safety regulations of the Thailand Ministry of Public Health, FDA & The US Department of Health & Human Services, Office of Dietary Supplements.
We have filed formal complaints with both the Inspector General's Office at the Thailand Ministry of Public Health, (FDA) and the US Department of Health & Human Services Special Investigators.
II. We fully support an upcoming GOFUNDME Community-fundraiser project to seek legal action directed toward those hi-tech corporations and individuals involved in illegal trafficking of non-GMP compliant, black market and/or adulterated dietary health supplements sold on the internet. This is NOT being adhered to by US FDA, hence the general public is at significant health risk because multi-billion dollar hi-tech corporations have employed evasive if not illegal internet mechanisms which have evolved faster than lawmakers in terms of monitoring and enforcing current public safety regulations.
The Dietary Supplement Health and Education Act of 1994 states;
§9. Good Manufacturing Practices. Section 402 (21 U.S.C. 342), as amended by section 4, is amended by adding at the end the following: “(g)(1) If it is a dietary supplement and it has been prepared, packed, or held under conditions that do not meet current good manufacturing practice regulations, including regulations requiring, when necessary, expiration date labeling, issued by the Secretary under subparagraph (2). “(2) The Secretary may by regulation prescribe good manufacturing practices for dietary supplements. Such regulations shall be modeled after current good manufacturing practice regulations for food and may not impose standards for which there is no current and generally available analytical methodology. No standard of current good manufacturing practice may be imposed unless such standard is included in a regulation promulgated after notice and opportunity for comment in accordance with chapter 5 of title 5, United States Code.”
Good Manufacturing Practices(GMP) Dietary supplement processors, manufacturers, and packers are responsible for ensuring that a dietary supplement or dietary supplement ingredient is safe by following GMP. [34]
GMP establish the minimum standards for activities related to manufacturing, packaging, labeling, or holding dietary supplements for the purposes of ensuring the product’s quality throughout the manufacturing process to minimize the risks of a potentially unsafe or otherwise illegal product from reaching the marketplace.
DSHEA gave FDA the authority to establish GMP specific to dietary supplements modeled after the existing GMP for food.[35]
Dietary supplement-specific GMP were requested by industry, citing concerns that GMP developed for conventional food products did not adequately address the unique characteristics of dietary supplements. These regulations were finalized in 2007,
[36] and largely addressed the concerns raised by the industry. Dietary supplement GMPs contain sections that detail additional quality control procedures and record keeping requirements for each step in the manufacturing process.
[37] Following GMP should ensure that final products do not include the wrong ingredients; too much or too little of a dietary ingredient;[38] contaminants such as natural toxins, bacteria, pesticides, glass, lead or other heavy metals; or improper packaging or labeling.
FDA noted in the final rule that “the focus of GMP is on process controls to ensure that the desired outcome is consistently achieved, and not on the inherent safety of the ingredients used.” [39]
GMP for dietary supplements apply to all domestic and foreign companies that manufacture, package, label, or hold a dietary supplement for import and sale in any state or territory of the United States, the District of Columbia, or Puerto Rico.[40] This includes those involved with testing, quality control, packaging and labeling, and distribution of dietary supplements, [but excludes retail establishments that are solely involved in the direct sale of dietary supplements to individual consumers] This "loophole" must be addressed to Congress immediately to stop the sale of these undocumented black market supplements being sold on internet stores such as Amazon, eBay, Etsy and others which cause 23,000 emergency room visits per year.
[33] Food and Drug Administration, “Draft Guidance for Industry, Dietary Supplements: New Dietary Ingredient Notifications and Related Issues,” 79 Federal Register 39111, July 5, 2011.
[34] 21 U.S.C. §342(g).
[ 35] 21 U.S.C. §342(g).
[36] Food and Drug Administration, “Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements; Final Rule,” 72 Federal Register 34752-34958, June 25, 2007.
[37] Food and Drug Administration, “Dietary Supplement Current Good Manufacturing Practices (CGMPs) and Interim Final Rule (IFR) Facts,” press release, June 22, 2007, http://www.fda.gov/Food/GuidanceRegulation/CGMP/ ucm110858.htm.
[38] Some researchers note that, for most botanicals, consensus has not been reached on analytical markers or standardized analytical methods for determining the presence or quantity of the botanical. For example, see J Kemsley, “Botanical Scrutiny,” Chemical and Engineering News, March 18, 2013, pp. 12-17.
[39] Food and Drug Administration, “Dietary Supplement Current Good Manufacturing Practices (CGMPs) and Interim Final Rule (IFR) Facts,” press release, June 22, 2007, http://www.fda.gov/Food/GuidanceRegulation/CGMP/ ucm110858.htm.
[40] 21 C.F.R. §111.1
§7. Dietary Supplement Ingredient Labeling and Nutrition Information Labeling. (a) MISBRANDED SUPPLEMENTS. - Section 403 (21 U.S.C. 343) is amended by adding at the end the following: “(s) If - “(1) it is a dietary supplement; and “(2)(A) the label or labeling of the supplement fails to list -
“(D) the supplement - “(i) is covered by the specifications of an official compendium; “(ii) is represented as conforming to the specifications of an official compendium; and “(iii) fails to so conform; or
“(E) the supplement - “(i) is not covered by the specifications of an official compendium; and “(ii)(I) fails to have the identity and strength that the supplement is represented to have; or
“(ii) the listing of dietary ingredients shall include the quantity of each such ingredient (or of a proprietary blend of such ingredients) per serving; “(iii) the listing of dietary ingredients may include the source of a dietary ingredient; and
“(iv) the nutrition information shall immediately precede the ingredient information required under subclause
(i), except that no ingredient identified pursuant to subclause (i) shall be required to be identified a second time.”.
(d) Vitamins and Minerals. Section 411(b)(2) (21 U.S.C. 350(b)(2)) is amended - (1) by striking “vitamins or minerals” and inserting “dietary supplement ingredients described in section 201(ff)”; (2) by striking “(2)(A)” and inserting “(2)”; and (3) by striking subparagraph (B). (e) Effective Date. Dietary supplements -
Siam Industries International, Co., Ltd.
23/555 Muban Thang Rot Fai Fang Tawan Tok Lane
Hua Hin, Phrachuap Khirikhan 77110 TH.
NaturePaq, inc.
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PO Box 881 Kealakekua, HI. 96750
info@naturepaq.net