Recent Changes in US Regulations

Feb 1, 2009 | Contact Author | By: David C. Steinberg, Steinberg & Associates
Your message has been sent.
(click to close)
Contact the Author
Save
This item has been saved to your library.
View My Library
(click to close)
Save to My Library
Title: Recent Changes in US Regulations
  • Article
  • Media
  • Keywords/Abstract

Excerpt Only This is a shortened version or summary of the article you requested. To view the complete article, please log in or create an account. Registration is Free!

Two recent changes to regulations will significantly impact the industry in 2009. These include changes to over-the-counter (OTC) labels, and the latest amendment to the Lacey Act. The most recent “Regulatory Review” column, published in December 2008, discussed the Lacey Act in brief but more details are emerging. Although neither of these regulatory changes will likely impact the way in which companies conduct business, they do require more information on product labels and will cause significantly more paperwork both for cosmetic companies and ingredient suppliers.

The Lacey Act Changes 
John F. Lacey introduced a law that President McKinley signed on May 25, 1900, now known as the Lacey Act, which made it a federal crime to poach game in one state with the purpose of selling the bounty in another state. It became the first law to protect these endangered animals and birds. As the first federal conservation law, it remains one of the foundations of conservation law enforcement today.

Excerpt Only This is a shortened version or summary of the article you requested. To view the complete article, please log in or create an account. Registration is Free!

 

Close

Data Required for USDA Registration of Lacey Act Materials

Estimated date of arrival
Entry number
Container number
Bill of Lading
MID
Importer name, address
Consignee name, address
Description of merchandise
HTSUS Number
Entry value (in US dollars)
Article:
- Genus and species
- Country of Harvest
- Quantity
- Unit of measurement
- Percentage of recycled material

Drug Facts Labeling

1. Drug Facts (title)
2. Active ingredient(s)–Note the lowercase “i” in ingredient. Companies must use USAN names only. This is followed by the dose or %, as stated in the Monograph. At the right is the purpose, again specified in the Monograph.
3. Purpose that is specified in the Monograph
4. Use or Uses, as specified in the Monograph
5. Warnings, as specified in the Monograph, along with FDA-mandated general warnings
6. Directions, as specified in the Monograph
7. Other information, which is optional
8. Inactive ingredients–Note the lowercase “i” in ingredients. Companies must use USAN names only and in alphabetical order if only making drug claims outside the Drug Facts label. If making any cosmetic claims, only the INCI names must be used in descending order of predominance, down to 1%—similar to a general cosmetic ingredient declaration.
9. Questions–This is also optional. If a phone number is listed, the FDA assumes that it is manned 24/7 by an individual unless designated times are stated.

Next image >

 
 

Close

It's Free...

Register or Log in to get full access to this content

Registration includes:

  • Access to all premium content
  • One click ingredient sample requests
  • Save articles in the My Library tool

Create an Account or Log In